Opioid Induced ConstipationPhase 4NCT03060512

To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation

A Phase 4 study testing Polyethylene Glycol 3350 and Movantik in people with Opioid Induced Constipation, run by AstraZeneca at 53 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350. Read more about this study

Who is it for?: Ages 18 to 84 years
Conditions the study is for: Opioid Induced Constipation
What is being tested?: Polyethylene Glycol 3350 and Movantik
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 53 sitesUnited States
Study dates: 2 Mar 2017to 23 Aug 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 84 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female between the ages of ≥18 and <85 years
Self-reported active symptoms of OIC (Opioid Induced Constipation) based on components of the Rome IV criteria at screening. Patients should have at least 2 of the following:
<3 SBMs (Spontaneous Bowel Movements) per week
Straining >25% of defecations
Sensation of incomplete evacuation >25% of defecations
Lumpy or hard stools >25% of defecations

Show all 10Show fewer

Sensation of anorectal obstruction/blockage >25% of defecations
Confirmed OIC by BFI (Bowel Function Index) ≥30
Stable maintenance opioid regimen consisting of a total daily dose of at least 30 mg of oral morphine, or equivalent of 1 or more other opioid therapies
Willingness to stop all laxatives and other bowel regimens other than specified rescue medication

Who cannot join

Pain related to cancer or has a history of cancer within 5 years
Current constipation or chronic constipation not caused by or related to use of opioids
History of rectal evacuation disorders, surgery or procedures that can potentially affect pelvic floor function; requirement of using manual maneuvers to facilitate a bowel movement
Evidence of significant GI structural abnormalities, acute or chronic GI conditions that could post risk to the patient or confound the study results
Recent surgery that may affect GI motility or increase risk for bowel obstruction or perforation
Severe hepatic impairment

Show all 10Show fewer

Moderate or severe renal impairment
Condition that may affect the permeability of blood-brain barrier
Concomitantly using strong or moderate CYP3A4 inhibitors and strong CYP3A4 inducers
Any other significant and/or progressive medical, surgical, psychiatric, or mental health condition or any significant laboratory findings that could increase the risk of participation in the study or affect the interpretation of study data as determined by the Investigator

Trial locations and contacts

53 sites in 1 country.

City, postcode or hospital

53 sites in 1 country

United States53 sites

Research Site
Albuquerque, New Mexico, 87102
Research Site
Anaheim, California, 92801
Research Site
Anaheim, California, 92805
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Atlanta, Georgia, 30342
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Beavercreek, Ohio, 45432
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Biloxi, Mississippi, 39531
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Bloomington, Illinois, 61701
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Brownsburg, Indiana, 46112
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Charlotte, North Carolina, 28204
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Chattanooga, Tennessee, 37421
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Collegeville, Pennsylvania, 19426
Research Site
Decatur, Georgia, 30030
Research Site
DeLand, Florida, 32720
Research Site
Edmond, Oklahoma, 73034
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Endwell, New York, 13760
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Fort Myers, Florida, 33912
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Greensboro, North Carolina, 27410
Research Site
Greer, South Carolina, 29651
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High Point, North Carolina, 27262
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Huntsville, Alabama, 35801
Research Site
Jacksonville, Florida, 32218
Research Site
Jacksonville, Florida, 32257
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Jupiter, Florida, 33458
Research Site
Kingsport, Tennessee, 37660
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Lake City, Florida, 32055
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Las Vegas, Nevada, 89119
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Levittown, Pennsylvania, 19056
Research Site
Lincoln, California, 95648
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Los Gatos, California, 95032
Research Site
Marietta, Georgia, 30060
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Miami, Florida, 33155
Research Site
Miami Springs, Florida, 33166
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North Hollywood, California, 91606
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North Miami Beach, Florida, 33162
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Omaha, Nebraska, 68114
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Orange, California, 92868
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Ormond Beach, Florida, 32174
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Phoenix, Arizona, 85020
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Phoenix, Arizona, 85050
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Phoenix, Arizona, 85051
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Pikesville, Maryland, 21208
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Plantation, Florida, 33317
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Port Orange, Florida, 32129
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San Diego, California, 92114
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St Louis, Missouri, 63141
Research Site
Trenton, New Jersey, 08611
Research Site
Troy, Michigan, 48085
Research Site
Waltham, Massachusetts, 02451
Research Site
West Jordan, Utah, 84088
Research Site
West Palm Beach, Florida, 33409
Research Site
Westminster, California, 92683
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Phase IV, Randomized, Multi-Center, Open-Label, Prospective, Crossover Study to Evaluate Patient Preference of Movantik™ Versus Polyethylene Glycol 3350 for Opioid-Induced Constipation (OIC) Treatment

The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.

Read the detailed description

This study is a prospective, randomized, open-label crossover study consisting of a 1-week washout period, a 2-week treatment period, another 1-week washout and a final 2-week treatment period. The study will assess the overall patient preference Movantik versus Polyethylene Glycol 3350 for the treatment of their opioid-induced constipation. This study will also evaluate the reasons for patient preference (only among subjects who indicate a preference), patient global impression of change, and change in bowel function over the treatment periods measured by Bowel Function Index. Patient's bowel movement diary will also be collected during the study.

Conditions: Opioid Induced Constipation
Being tested: Polyethylene Glycol 3350, Movantik
Keywords: Opioid Induced constipation,, constipation,, laxative,, bowel movement,, Movantik,, Naloxegol
Medical subject headings: Opioid-Induced Constipation, Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Polyethylene Glycol 3350Drug
Also called MiraLAX
Polyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
MovantikDrug
Also called Naloxegol
Movantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.

Study groups in NCT03060512
Study group	Role	What they receive
Crossover Group 1	Active comparator	Crossover Group Movantik to Polyethylene Glycol 3350 2-period, 2-treatment cross-over model: Subjects will be randomized to Movantik during Treatment period 1 (2 weeks), then crossed over to receive Polyethylene Glycol 3350 for Treatment period 2 (2 weeks) after 1 week washout. Receives: Drug: Polyethylene Glycol 3350; Drug: Movantik
Crossover Group 2	Active comparator	Crossover group Polyethylene Glycol 3350 to Movantik 2-period, 2-treatment cross-over model: Subjects will be randomized to Polyethylene Glycol 3350 during Treatment period 1 (2 weeks), then crossed over to receive Movantik for Treatment period 2 (2 weeks) after 1 week washout. Receives: Drug: Polyethylene Glycol 3350; Drug: Movantik

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment
The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The 3 categories were formed by collapsing the 7-point rating scale to: 1. Prefer Movantik (including Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik), 2. No preference, and 3. Prefer PEG 3350 (including Strong preference for PEG 3350, Moderate preference for PEG 3350, and Slight preference for PEG 3350). The number of subjects in each category is presented for the total number of subjects in the Per-Protocol (PP) Set.
Measured: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence
The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The following categories were the possible responses: Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik, No preference, Slight preference for PEG 3350, Moderate preference for PEG 3350 and Strong preference for PEG 3350. Prefer Movantik included subjects in the categories Strong preference for Movantik, Moderate preference for Movantik and Slight preference for Movantik. Prefer PEG 3350 included subjects in the categories Strong preference for PEG 3350, Moderate preference for PEG 3350 and Slight preference for PEG 3350. Preference for Period 1 treatment and Preference for Period 2 treatment included subjects who preferred the first and second treatments respectively taken within a given treatment sequence. The number of subjects in each category is presented per treatment sequence for subjects in the PP Set.
Measured: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).

Secondary outcomes (5)

Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350
In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the median score for each characteristic is presented for the overall PP Set according to which treatment was preferred.
The assessment was only completed by subjects who indicated an overall preference.
Measured: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350
In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the number of subjects in each characteristic category is presented for the overall PP Set according to which treatment was preferred.
The assessment was only completed by subjects who indicated an overall preference.
Measured: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms
PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The scoring was as follows: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real difference; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms.
Mean score results are presented for each treatment for Visits 3 and 5.
Measured: At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.
PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms
PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The subjects selected one of the following PGIC items as their response: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real differences; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms.
The number of subjects responding to each PGIC item at Visits 3 and/or 5 is presented for each treatment overall.
Measured: At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.
Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms
The BFI is a 3-item questionnaire administered by a study clinician to measure constipation from the subject's perspective (ease of defecation, feeling of complete evacuation, and personal judgment of constipation). For each item the subject was asked to rate their response on a scale from 0 to 100, where 0 indicates the best response (easy/no diffculty) and 100 the worst response (severe difficulty). The total BFI score was calculated as the mean of the 3 item scores.
The mean change from baseline in BFI scores at Visits 3 and/or 5 are presented.
Measured: From Baseline (Visit 2, Day 1) to Visit 3 (Day 15) and Visit 5 (Day 36).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 201723 Aug 2017

First posted23 Feb 2017
Study start2 Mar 2017
Primary completion23 Aug 2017
Study completion23 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Opioid Induced ConstipationStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03060512
Sponsor's protocol ID: D3820L00017
Status last verified: Jul 2018
First submitted: 13 Feb 2017
Last updated: 13 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Argoff CE, Brennan MJ, Camilleri M, Davies A, Fudin J, Galluzzi KE, Gudin J, Lembo A, Stanos SP, Webster LR. Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation. Pain Med. 2015 Dec;16(12):2324-37. doi: 10.1111/pme.12937. Epub 2015 Nov 19.
PubMed 26582720
Bell TJ, Panchal SJ, Miaskowski C, Bolge SC, Milanova T, Williamson R. The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1). Pain Med. 2009 Jan;10(1):35-42. doi: 10.1111/j.1526-4637.2008.00495.x. Epub 2008 Aug 18.
PubMed 18721170
Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014 Oct;26(10):1386-95. doi: 10.1111/nmo.12417. Epub 2014 Aug 28.
PubMed 25164154
Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.
PubMed 24896818
Coyne KS, LoCasale RJ, Datto CJ, Sexton CC, Yeomans K, Tack J. Opioid-induced constipation in patients with chronic noncancer pain in the USA, Canada, Germany, and the UK: descriptive analysis of baseline patient-reported outcomes and retrospective chart review. Clinicoecon Outcomes Res. 2014 May 23;6:269-81. doi: 10.2147/CEOR.S61602. eCollection 2014.
PubMed 24904217
Coyne KS, Margolis MK, Yeomans K, King FR, Chavoshi S, Payne KA, LoCasale RJ. Opioid-Induced Constipation Among Patients with Chronic Noncancer Pain in the United States, Canada, Germany, and the United Kingdom: Laxative Use, Response, and Symptom Burden Over Time. Pain Med. 2015 Aug;16(8):1551-65. doi: 10.1111/pme.12724. Epub 2015 Mar 20.
PubMed 25802051
Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.
PubMed 14739871
Holzer P. New approaches to the treatment of opioid-induced constipation. Eur Rev Med Pharmacol Sci. 2008 Aug;12 Suppl 1(0 1):119-27.
PubMed 18924451
Johanson JF. Review of the treatment options for chronic constipation. MedGenMed. 2007 May 2;9(2):25.
PubMed 17955081
Kumar L, Barker C, Emmanuel A. Opioid-induced constipation: pathophysiology, clinical consequences, and management. Gastroenterol Res Pract. 2014;2014:141737. doi: 10.1155/2014/141737. Epub 2014 May 5.
PubMed 24883055
McGraw T. Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial. Clin Exp Gastroenterol. 2016 Jul 15;9:173-80. doi: 10.2147/CEG.S111693. eCollection 2016.
PubMed 27486340
Brenner DM, Hu Y, Datto C, Creanga D, Camilleri M. A Randomized, Multicenter, Prospective, Crossover, Open-Label Study of Factors Associated With Patient Preferences for Naloxegol or PEG 3350 for Opioid-Induced Constipation. Am J Gastroenterol. 2019 Jun;114(6):954-963. doi: 10.14309/ajg.0000000000000229.
PubMed 31058652

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Opioid-Induced Constipation (OIC)
Not yet recruitingPhase 3
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OIC
RecruitingObservational study
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Cancer, Opioid Induced Constipation (OIC)

All Opioid Induced Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Randomized, Multi-Center, Open-Label, Prospective, Crossover Study to Evaluate Patient Preference of Movantik™ Versus Polyethylene Glycol 3350 for Opioid-Induced Constipation (OIC) Treatment
ClinicalTrials.gov ID: NCT03060512
Acronym / sponsor ID: D3820L00017
Conditions: Opioid Induced Constipation
Keywords: Opioid Induced constipation,, constipation,, laxative,, bowel movement,, Movantik,, Naloxegol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: QuintilesIMS, Inc.
Study start: 2 Mar 2017 (actual)
Primary completion: 23 Aug 2017 (actual)
Study completion: 23 Aug 2017 (actual)
First posted: 23 Feb 2017 (actual)
Results: Posted 13 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Crossover Group 1	Active comparator	Drug: Polyethylene Glycol 3350, Drug: MovantikCrossover Group Movantik to Polyethylene Glycol 3350 2-period, 2-treatment cross-over model: Subjects will be randomized to Movantik during Treatment period 1 (2 weeks), then crossed over to receive Polyethylene Glycol 3350 for Treatment period 2 (2 weeks) after 1 week washout.
Crossover Group 2	Active comparator	Drug: Polyethylene Glycol 3350, Drug: MovantikCrossover group Polyethylene Glycol 3350 to Movantik 2-period, 2-treatment cross-over model: Subjects will be randomized to Polyethylene Glycol 3350 during Treatment period 1 (2 weeks), then crossed over to receive Movantik for Treatment period 2 (2 weeks) after 1 week washout.

Who may qualify

Ages: 18 to 84 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female between the ages of ≥18 and <85 years
Self-reported active symptoms of OIC (Opioid Induced Constipation) based on components of the Rome IV criteria at screening. Patients should have at least 2 of the following:
Confirmed OIC by BFI (Bowel Function Index) ≥30
Stable maintenance opioid regimen consisting of a total daily dose of at least 30 mg of oral morphine, or equivalent of 1 or more other opioid therapies
Willingness to stop all laxatives and other bowel regimens other than specified rescue medication

Key exclusion criteria (10 listed)

Pain related to cancer or has a history of cancer within 5 years
Current constipation or chronic constipation not caused by or related to use of opioids
History of rectal evacuation disorders, surgery or procedures that can potentially affect pelvic floor function; requirement of using manual maneuvers to facilitate a bowel movement
Evidence of significant GI structural abnormalities, acute or chronic GI conditions that could post risk to the patient or confound the study results
Recent surgery that may affect GI motility or increase risk for bowel obstruction or perforation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Polyethylene Glycol 3350Also: MiraLAXPolyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day. Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.	Drug	Crossover Group 1, Crossover Group 2
MovantikAlso: NaloxegolMovantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal. Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.	Drug	Crossover Group 1, Crossover Group 2

Primary outcome

Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment
Time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The 3 categories were formed by collapsing the 7-point rating scale to: 1. Prefer Movantik (including Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik), 2. No preference, and 3. Prefer PEG 3350 (including Strong preference for PEG 3350, Moderate preference for PEG 3350, and Slight preference for PEG 3350). The number of subjects in each category is presented for the total number of subjects in the Per-Protocol (PP) Set.
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence
Time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The following categories were the possible responses: Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik, No preference, Slight preference for PEG 3350, Moderate preference for PEG 3350 and Strong preference for PEG 3350. Prefer Movantik included subjects in the categories Strong preference for Movantik, Moderate preference for Movantik and Slight preference for Movantik. Prefer PEG 3350 included subjects in the categories Strong preference for PEG 3350, Moderate preference for PEG 3350 and Slight preference for PEG 3350. Preference for Period 1 treatment and Preference for Period 2 treatment included subjects who preferred the first and second treatments respectively taken within a given treatment sequence. The number of subjects in each category is presented per treatment sequence for subjects in the PP Set.

5 secondary outcomes

Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350
Time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350
Time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms
Time frame: At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.
PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms
Time frame: At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.
Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms
Time frame: From Baseline (Visit 2, Day 1) to Visit 3 (Day 15) and Visit 5 (Day 36).

Results and safety

Results posted to the registry on 13 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Movantik, Then PEG 3350	137	130
PEG 3350, Then Movantik	139	130

Primary outcome: Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment

Time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).. Count of participants. Unit: Participants

Measure	Total (PP Set) n = 246
Prefer Movantik	124
Prefer PEG 3350	118
No preference	4

Population analysed: The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation.

Primary outcome: Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence

Time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).. Count of participants. Unit: Participants

Measure	Movantik, Then PEG 3350 n = 125	PEG 3350, Then Movantik n = 121
Strong preference for Movantik	37	38
Moderate preference for Movantik	14	17
Slight preference for Movantik	11	7
No preference	2	2
Slight preference for PEG 3350	9	8
Moderate preference for PEG 3350	15	23
Strong preference for PEG 3350	37	26
Prefer Movantik	62	62

Movantik, Then PEG 3350 vs PEG 3350, Then Movantik: p = 0.9239, Prescott's test
Movantik, Then PEG 3350 vs PEG 3350, Then Movantik: p = 0.8874, Prescott's test

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 5 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Movantik	3 of 271 (1.1%)	66 of 271 (24.4%)	0 of 271
PEG 3350	1 of 268 (0.4%)	46 of 268 (17.2%)	0 of 268

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26582720Argoff CE, Brennan MJ, Camilleri M, Davies A, Fudin J, Galluzzi KE, Gudin J, Lembo A, Stanos SP, Webster LR. Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation. Pain Med. 2015 Dec;16(12):2324-37. doi: 10.1111/pme.12937. Epub 2015 Nov 19.
Results publication: PubMed 18721170Bell TJ, Panchal SJ, Miaskowski C, Bolge SC, Milanova T, Williamson R. The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1). Pain Med. 2009 Jan;10(1):35-42. doi: 10.1111/j.1526-4637.2008.00495.x. Epub 2008 Aug 18.
Results publication: PubMed 25164154Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014 Oct;26(10):1386-95. doi: 10.1111/nmo.12417. Epub 2014 Aug 28.
Results publication: PubMed 24896818Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.
Results publication: PubMed 24904217Coyne KS, LoCasale RJ, Datto CJ, Sexton CC, Yeomans K, Tack J. Opioid-induced constipation in patients with chronic noncancer pain in the USA, Canada, Germany, and the UK: descriptive analysis of baseline patient-reported outcomes and retrospective chart review. Clinicoecon Outcomes Res. 2014 May 23;6:269-81. doi: 10.2147/CEOR.S61602. eCollection 2014.
Results publication: PubMed 25802051Coyne KS, Margolis MK, Yeomans K, King FR, Chavoshi S, Payne KA, LoCasale RJ. Opioid-Induced Constipation Among Patients with Chronic Noncancer Pain in the United States, Canada, Germany, and the United Kingdom: Laxative Use, Response, and Symptom Burden Over Time. Pain Med. 2015 Aug;16(8):1551-65. doi: 10.1111/pme.12724. Epub 2015 Mar 20.
Results publication: PubMed 14739871Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.
Results publication: PubMed 18924451Holzer P. New approaches to the treatment of opioid-induced constipation. Eur Rev Med Pharmacol Sci. 2008 Aug;12 Suppl 1(0 1):119-27.
Results publication: PubMed 17955081Johanson JF. Review of the treatment options for chronic constipation. MedGenMed. 2007 May 2;9(2):25.
Results publication: PubMed 24883055Kumar L, Barker C, Emmanuel A. Opioid-induced constipation: pathophysiology, clinical consequences, and management. Gastroenterol Res Pract. 2014;2014:141737. doi: 10.1155/2014/141737. Epub 2014 May 5.
Results publication: PubMed 27486340McGraw T. Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial. Clin Exp Gastroenterol. 2016 Jul 15;9:173-80. doi: 10.2147/CEG.S111693. eCollection 2016.
Derived from this study: PubMed 31058652Brenner DM, Hu Y, Datto C, Creanga D, Camilleri M. A Randomized, Multicenter, Prospective, Crossover, Open-Label Study of Factors Associated With Patient Preferences for Naloxegol or PEG 3350 for Opioid-Induced Constipation. Am J Gastroenterol. 2019 Jun;114(6):954-963. doi: 10.14309/ajg.0000000000000229.
Movantik\_D3820L00017\_Protocol\_Original-26Jan17\_Redacted\_PDF-ALink provided by the sponsor.
Movantik\_D3820L00017\_SAP\_Redacted\_15Aug2017\_PDF-ALink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Scientific Leadership study director

AstraZeneca

53 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Polyethylene Glycol 3350 and Movantik in people with Opioid Induced Constipation, run by AstraZeneca at 53 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment (time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03060512, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.