ConstipationPhase 4NCT01170039

The Effectiveness of Lubiprostone in Constipated Diabetics

A Phase 4 study testing Lubiprostone in people with Constipation and Diabetes, run by Emory University at 2 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

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Constipation, Diabetes
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: 121 participants
Where: 2 sitesUnited States
Study dates: Sep 2010to Oct 2014
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 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diabetic patients with constipation.
Patient must be on stable oral or subcutaneous hypoglycemic medication for 6 months.

Who cannot join

Acute infections
Ischemic bowel syndrome
Gastrointestinal obstruction

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Atlanta Veterans Administration Hospital
Atlanta, Georgia, 30033
The Emory Clinic
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo-controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients

The investigators will recruit a total of 136 diabetic men and women with constipation into this study from both The Emory Clinic and The Atlanta Veteran's Administration Hospital. The investigators will track spontaneous bowel movements defined as a bowel movement in 24 hours after initiation of study drug (SBMs) in all patients two weeks before treatment with lubiprostone as well as measure baseline colonic transit using the Smartpill pH capsule. Colon transit reflects that rate of colonic peristalsis and movement of stool through the large bowel.

Patients will receive either lubiprostone 24 micrograms (mcg) orally twice a day for 8 weeks or placebo. Primary and secondary endpoints will be the number of SBMs/week and colonic transit time as measured by the Smartpill capsule, respectively. The number of SBMs/week will be evaluated at 0, 2, 4 and 8 weeks after initiation of therapy. The investigators will over-sample African American patients to achieve approximately 50% enrollment of this group. In a subanalysis, the investigators will assess response to treatment between the general population and African Americans.

We hypothesize that lubiprostone will significantly increase the number of SBMs as well as decrease colonic transit time and improve quality of life in constipated diabetic patients compared with placebo.

Read the detailed description

Diabetes mellitus (DM) is very common in the United States, and the incidence as well as prevalence of this disease are increasing. DM is not only a risk factor for cardiovascular and pulmonary conditions, but is also linked with several digestive complications. Among digestive complaints, constipation occurs in approximated two-thirds of patients with DM, making constipation the most common gastrointestinal (GI) complaint among type 2 diabetics. Consequently, these patients suffer abdominal pain, bloating, and have a lower health related quality of life when compared with patients without DM and GI symptoms.Constipated individuals may be reluctant to eat on a regular schedule which may worsen glycemic control as well as the symptoms related to an underlying diabetic enteropathy.

Effective therapies for constipation are limited and there is little data evaluating the treatment of constipation, specifically in diabetic patients. Lubiprostone has been shown to be superior to placebo in increasing the number of spontaneous bowel movements (SBMs) in patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). However, lubiprostone has not been previously studied in diabetics suffering with constipation. Furthermore, other prokinetic pharmacotherapeutics targeted toward constipated patients with diabetes mellitus type 2 are lacking.

African Americans have the highest rate of DM compared with other ethnic groups in the Unites States. Furthermore, constipation is more prevalent in African Americans compared with other minority groups. However, there is little data evaluating the prevalence of constipation and the response to treatment in African Americans. Therefore, more information regarding the severity of symptoms, differences in bowel patterns, colonic transit, and response to therapy is important to improving the management of constipation in this group. Hence, in a subanalysis, we will study whether the responsiveness of African American patients to lubiprostone differs from that of the general population.

Given the dearth of information on the effectiveness of lubiprostone in diabetics, who have a particularly strong need for alternative safe and effective treatments for constipation, we propose to assess the effectiveness of lubiprostone in constipated diabetic men and women.

This is a randomized double- blind placebo controlled trial of lubiprostone in the treatment of constipation in diabetic patients.

Conditions: Constipation, Diabetes
Being tested: Lubiprostone, Placebo
Keywords: Constipation, Diabetes, Lubiprostone, Amitiza, African Americans
Medical subject headings: Constipation, Diabetes Mellitus

What participants receive

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

LubiprostoneDrug
Also called Amitiza
Lubiprostone will be given as 24 mcg orally twice a day.
PlaceboDrug
A matched placebo pill will be given twice a day for 8 weeks.

Study groups in NCT01170039
Study group	Role	What they receive
Lubiprostone	Active comparator	Not described Receives: Drug: Lubiprostone
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week
The average number of spontaneous bowel movements calculated per week from baseline to 8 weeks was recorded. The number of spontaneous bowel movements was recorded by the subjects in a daily stool diary and the weekly average was calculated. Spontaneous bowel movements are bowel movements within a 24 hour period independent of rescue medication use within the previous week.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks

Secondary outcomes (3)

Efficacy, Measured by the Duration of Colonic Transit Time as Measured by the SmartPill pH Capsule
The duration of colonic transit time in hours was measured by the SmartPill pH Capsule. Colonic transit time is the time interval from the cecal entry of the capsule to anal expulsion and was measured in hours.
Measured: Baseline, 4 weeks
Number of Subjects With Daily Abdominal Discomfort
The number of subjects experiencing abdominal discomfort was recorded weekly.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
Change in Scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire
The difference in the scores on the self-reported Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. The quality of life is measured by the by the overall scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, a validated 28-item questionnaire measuring quality of life as it pertains to constipation. The 28 items are grouped into four subscales, 1) worries and concerns, 2) physical discomfort, 3) psychosocial discomfort, and 4) satisfaction. A 5-point Likert response scale, ranging from 0 (Not at all/None of the time) to 4 (Extremely/ All of the time), is used. The subscale scores vary from 0 to 4 and the total (global) score ranges from 0 to 4. A lower score indicates better quality of life (QOL).
Measured: Screening, 8 weeks

Timeline

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

Sep 2010Oct 2014

First posted27 Jul 2010 (estimated)
Study startSep 2010
Primary completionOct 2014
Study completionOct 2014

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.
Other trials for ConstipationStudies of the same condition, open and under way.
More trials run by Emory UniversityThe 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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01170039
Sponsor's protocol ID: IRB00014592
Status last verified: Feb 2016
First submitted: 23 Jul 2010
Last updated: 15 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
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All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo-controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients
ClinicalTrials.gov ID: NCT01170039
Acronym / sponsor ID: IRB00014592
Conditions: Constipation, Diabetes
Keywords: Constipation, Diabetes, Lubiprostone, Amitiza, African Americans
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: Sep 2010
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 27 Jul 2010 (estimated)
Results: Posted 15 Mar 2016

Clinical summary

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

Detailed description

This is a randomized double- blind placebo controlled trial of lubiprostone in the treatment of constipation in diabetic patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lubiprostone	Active comparator	Drug: Lubiprostone
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diabetic patients with constipation.
Patient must be on stable oral or subcutaneous hypoglycemic medication for 6 months.

Key exclusion criteria (3 listed)

Acute infections
Ischemic bowel syndrome
Gastrointestinal obstruction

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: AmitizaLubiprostone will be given as 24 mcg orally twice a day.	Drug	Lubiprostone
PlaceboA matched placebo pill will be given twice a day for 8 weeks.	Drug	Placebo

Primary outcome

Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week
Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
The average number of spontaneous bowel movements calculated per week from baseline to 8 weeks was recorded. The number of spontaneous bowel movements was recorded by the subjects in a daily stool diary and the weekly average was calculated. Spontaneous bowel movements are bowel movements within a 24 hour period independent of rescue medication use within the previous week.

3 secondary outcomes

Efficacy, Measured by the Duration of Colonic Transit Time as Measured by the SmartPill pH Capsule
Time frame: Baseline, 4 weeks
Number of Subjects With Daily Abdominal Discomfort
Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
Change in Scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire
Time frame: Screening, 8 weeks

Results and safety

Results posted to the registry on 15 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lubiprostone	37	29
Placebo	39	33

Primary outcome: Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week

Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks. Mean (Standard Deviation). Unit: spontaneous bowel movements

Measure	Lubiprostone n = 35	Placebo n = 39
1 week	4.85 (5.27)	1.40 (3.27)
2 weeks	3.81 (5.60)	2.41 (4.29)
3 weeks	5.76 (4.99)	3.11 (4.34)
4 weeks	4.12 (4.63)	2.48 (3.68)
5 weeks	5.28 (4.10)	3.03 (4.33)
6 weeks	4.52 (5.37)	3.23 (3.95)
7 weeks	4.65 (5.27)	3.46 (3.59)
8 weeks	5.30 (4.42)	2.63 (3.81)

Population analysed: Two subjects in the Lubiprostone arm did not complete the daily stool diary at baseline. No data was analyzed for these two subjects.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lubiprostone	0 of 37 (0%)	28 of 37 (75.7%)	Not reported
Placebo	0 of 39 (0%)	25 of 39 (64.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Constipation

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
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RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic 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)
Not yet recruiting
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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.

Jennifer A Christie, MD principal investigator

Emory University

Latoya Carter study director

Emory University

2 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 Lubiprostone in people with Constipation and Diabetes, run by Emory University at 2 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 2 inclusion and 3 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 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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 15 Mar 2016). 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?

Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week (time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks). 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 NCT01170039.

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 15 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.