Chronic Idiopathic ConstipationPhase 3NCT03097861

Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo

A Phase 3 study testing Lubiprostone in people with Chronic Idiopathic Constipation, run by Sucampo Pharma Americas, LLC at 67 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 evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Idiopathic Constipation
What is being tested?: Lubiprostone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 552 participants
Where: 67 sitesUnited States
Study dates: 13 Mar 2017to 17 Aug 2017
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or meets the diagnosis as confirmed using the Rome III constipation module questionnaire during the Screening period.
Is male or female, 18 or older years of age
Should be on stable dose of fiber supplement or a concomitant medication for the indication of lowering blood pressure

Who cannot join

Has any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
Is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting

Trial locations and contacts

67 sites in 1 country.

City, postcode or hospital

67 sites in 1 country

United States67 sites

Investigative Site
Anaheim, California, 92805
Investigative Site
Athens, Georgia, 30607
Investigative Sitee
Bellevue, Nebraska, 68005
Investigative Site
Birmingham, Alabama, 35216
Investigative Site
Blackfoot, Idaho, 83221
Investigative Site
Boise, Idaho, 83712
Investigative Site
Charleston, South Carolina, 29406
Investigative Site
Chattanooga, Tennessee, 37421
Investigative Site
Chevy Chase, Maryland, 20815
Investigative Sitee
Chula Vista, California, 91910
Investigative Site
Clearwater, Florida, 33765
Investigative Site
Cleveland, Ohio, 44122
Investigative Site
Colorado Springs, Colorado, 80909
Investigative Site
Coral Springs, Florida, 33065
Investigative Site
DeLand, Florida, 32720
Investigative Site
Foley, Alabama, 36535
Investigative Site
Garden Grove, California, 92840
Investigative Site
Hagerstown, Maryland, 21742
Investigative Site
Hialeah, Florida, 33012
Investigative Sitee
High Point, North Carolina, 27262
Investigative Site
Houston, Texas, 77058
Investigative Site
Houston, Texas, 77099
Investigative Site
Jackson, Missouri, 39202
Investigative Site 2
Jackson, Tennessee, 38305
Investigative Site
Jackson, Tennessee, 38305
Investigative Site
Jupiter, Florida, 33458
Investigative Site
Lake Charles, Louisiana, 70601
Investigative Site
Las Vegas, Nevada, 89119
Investigative Site
Layton, Utah, 84041
Investigative Site
Little Rock, Arkansas, 72212
Investigative Site
Long Beach, California, 90806
Investigative Site
Longview, Texas, 75605
Investigative Site
Los Angeles, California, 90057
Investigative Site
McAllen, Texas, 78504
Investigative Site
Mentor, Ohio, 44060
Investigative Site
Meridian, Idaho, 83642
Investigative Site
Miami, Florida, 33142
Investigative Site 2
Miami, Florida, 33143
Investigative Site
Miami, Florida, 33143
Investigative Site
Miami, Florida, 33165
Investigative Site
Midwest City, Oklahoma, 73110
Investigative Site
New Bedford, Massachusetts, 02740
Investigative Site
New London, Connecticut, 06320
Investigative Site
New Orleans, Louisiana, 70124
Investigative Site
Newport News, Virginia, 23606
Investigative Site
Orlando, Florida, 32806
Investigative Site
Panorama City, California, 91402
Investigative Site
Philadelphia, Pennsylvania, 19152
Investigative Site
Plantation, Florida, 33322
Investigative Sitee
Port Orange, Florida, 32129
Investigative Site
Port Saint Lucie, Florida, 34952
Investigative Site
Raleigh, North Carolina, 27612
Investigative Site
Richmond, Virginia, 23220
Investigative Site
San Diego, California, 92103
Investigative Site
San Marcos, California, 92078
Investigative Site
Shreveport, Louisiana, 71101
Investigative Site
Snellville, Georgia, 30078
Investigative Site
Spartanburg, South Carolina, 29303
Investigative Site
Stockbridge, Georgia, 30281
Investigative Site
Sugar Land, Texas, 77479
Investigative Site
Tampa, Florida, 33609
Investigative Site
Tampa, Florida, 33634
Investigative Site
Taylorsville, Utah, 84123
Investigative Site
The Bronx, New York, 10459
Investigative Site
Upland, California, 91786
Investigative Site
West Jordan, Utah, 84088
Investigative Site
West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects With Chronic Idiopathic Constipation

Conditions: Chronic Idiopathic Constipation
Being tested: Lubiprostone, Placebo

What participants receive

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

LubiprostoneDrug
Also called Amitiza
24 mcg administered orally BID
PlaceboDrug
24 mcg administered orally BID

Study groups in NCT03097861
Study group	Role	What they receive
Lubiprostone Capsule	Active comparator	Lubiprostone 24 mcg capsule twice daily (BID) for 7 days. Receives: Drug: Lubiprostone
Lubiprostone Sprinkle	Experimental	Lubiprostone 24 mcg sprinkle BID for 7 days. Receives: Drug: Lubiprostone
Placebo	Placebo comparator	Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days. Receives: Drug: Placebo

What is being measured

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

Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week
Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period.
Measured: during the 1-week treatment period

Secondary outcomes (3)

Mean SBM Consistency Score Within 1 Week
Stool consistency associated with SBMs was rated according to the 7-point Bristol Stool Form Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass), 2 = Sausage-shaped but lumpy, 3 = Like a sausage but with cracks on the surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges (passed easily), 6 = Fluffy pieces with ragged edges, a mushy stool, 7 = Watery, no solid pieces; entirely liquid. Scores in the mid-range of this scale indicate better stool consistency.
Measured: during the 1-week treatment period
Mean SBM Straining Score Within 1 Week
Bowel straining associated with SBMs was rated on a scale of 0-4 where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Higher score indicates more straining, so a worse condition.
Measured: during the 1-week treatment period
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is an episode which occur after the administration of the first dose of study medication and within 7 days after final dose.
Measured: From first dose of study medication to follow-up (up to 15 days)

Timeline

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

13 Mar 201717 Aug 2017

First posted31 Mar 2017
Study start13 Mar 2017
Primary completion17 Aug 2017
Study completion17 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 (1)Papers the sponsor has linked to this study.
Other trials for Chronic Idiopathic ConstipationStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 552 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03097861
Sponsor's protocol ID: SCMP-0211-302
Status last verified: Jan 2020
First submitted: 27 Mar 2017
Last updated: 14 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Adams A, Barish C, Chen A, Dennis P, Krause R, Lichtlen P, Losch-Beridon T, Mareya S, Schneider J. Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation. Adv Ther. 2021 Jun;38(6):2936-2952. doi: 10.1007/s12325-021-01707-9. Epub 2021 Apr 8.
PubMed 33834354

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

Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
Active, not recruitingObservational study
Post-Marketing Study of Prucalopride Safety In Pregnancy
Chronic Idiopathic Constipation (CIC)
RecruitingPhase 3
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Chronic Idiopathic Constipation (CIC)
RecruitingObservational study
A Study of Prucalopride in Breastfeeding Women With Constipation
Chronic Idiopathic Constipation (CIC)

All Chronic Idiopathic Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects With Chronic Idiopathic Constipation
ClinicalTrials.gov ID: NCT03097861
Acronym / sponsor ID: SCMP-0211-302
Conditions: Chronic Idiopathic Constipation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 552 participants (actual)
Lead sponsor: Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
Collaborators: Sucampo AG, Sucampo Pharmaceuticals, Inc.
Study start: 13 Mar 2017 (actual)
Primary completion: 17 Aug 2017 (actual)
Study completion: 17 Aug 2017 (actual)
First posted: 31 Mar 2017 (actual)
Results: Posted 14 Jan 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Lubiprostone Capsule	Active comparator	Drug: LubiprostoneLubiprostone 24 mcg capsule twice daily (BID) for 7 days.
Lubiprostone Sprinkle	Experimental	Drug: LubiprostoneLubiprostone 24 mcg sprinkle BID for 7 days.
Placebo	Placebo comparator	Drug: PlaceboPlacebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.

Who may qualify

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

Key inclusion criteria (3 listed)

Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or meets the diagnosis as confirmed using the Rome III constipation module questionnaire during the Screening period.
Is male or female, 18 or older years of age
Should be on stable dose of fiber supplement or a concomitant medication for the indication of lowering blood pressure

Key exclusion criteria (2 listed)

Has any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
Is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting

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
LubiprostoneAlso: Amitiza24 mcg administered orally BID	Drug	Lubiprostone Capsule, Lubiprostone Sprinkle
Placebo24 mcg administered orally BID	Drug	Placebo

Primary outcome

Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week
Time frame: during the 1-week treatment period
Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period.

3 secondary outcomes

Mean SBM Consistency Score Within 1 Week
Time frame: during the 1-week treatment period
Mean SBM Straining Score Within 1 Week
Time frame: during the 1-week treatment period
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study medication to follow-up (up to 15 days)

Results and safety

Results posted to the registry on 14 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	145	138
Lubiprostone Sprinkle	276	254
Lubiprostone Capsule	131	122

Primary outcome: Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week

Time frame: during the 1-week treatment period. Mean (Standard Deviation). Unit: SBMs/week

Measure	Placebo n = 126	Lubiprostone Sprinkle n = 234	Lubiprostone Capsule n = 113
Baseline	1.38 (0.692)	1.37 (0.693)	1.35 (0.720)
Week 1	3.68 (2.164)	4.82 (3.658)	5.74 (3.786)

Placebo vs Lubiprostone Sprinkle: p =0.0020, ANCOVA
Placebo vs Lubiprostone Capsule: p <0.0001, ANCOVA

Population analysed: Per protocol population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: from first dose of study medication through a 1-week follow-up (up to 15 days). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 143 (0%)	15 of 143 (10.5%)	0 of 143
Lubiprostone Sprinkle	0 of 275 (0%)	50 of 275 (18.2%)	0 of 275
Lubiprostone Capsule	0 of 130 (0%)	29 of 130 (22.3%)	0 of 130

Limitations and caveats (from the sponsor): Actual randomization ratio (2:1:1) was different than the planned ratio (1:1:1).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33834354Adams A, Barish C, Chen A, Dennis P, Krause R, Lichtlen P, Losch-Beridon T, Mareya S, Schneider J. Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation. Adv Ther. 2021 Jun;38(6):2936-2952. doi: 10.1007/s12325-021-01707-9. Epub 2021 Apr 8.
Individual participant dataSharing planned: No

Related trials for Chronic Idiopathic Constipation

Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
Active, not recruitingObservational study
Post-Marketing Study of Prucalopride Safety In Pregnancy
Chronic Idiopathic Constipation (CIC)
RecruitingPhase 3
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Chronic Idiopathic Constipation (CIC)
RecruitingObservational study
A Study of Prucalopride in Breastfeeding Women With Constipation
Chronic Idiopathic Constipation (CIC)

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.

Global Clinical Leader study director

Mallinckrodt

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lubiprostone in people with Chronic Idiopathic Constipation, run by Sucampo Pharma Americas, LLC at 67 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 3 inclusion and 2 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 Jan 2020). 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?

Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week (time frame: during the 1-week treatment period). 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 NCT03097861, which also lists 1 linked publication.

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 14 Jan 2020.