Chronic ConstipationPhase 3NCT00765882

Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

A Phase 3 study testing Linaclotide 290 micrograms and Linaclotide 145 micrograms in people with Chronic Constipation, run by Forest Laboratories at 108 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Constipation
What is being tested?: Linaclotide 290 micrograms and Linaclotide 145 micrograms
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 633 participants
Where: 108 sitesin 2 countries
Study dates: Sep 2008to Aug 2009
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

Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
Patient meets protocol criteria for CC: reports < 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
Patient demonstrates continued chronic constipation through Pretreatment Period
Patient is compliant with IVRS

Who cannot join

Patient has history of loose or watery stools
Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

Trial locations and contacts

108 sites in 2 countries.

Country

City, postcode or hospital

108 sites in 2 countries

United States100 sites

Forest Investigative Site
Akron, Ohio, 44302
Forest Investigative Site
Albuquerque, New Mexico, 87106
Forest Investigative Site
Arkansas City, Kansas, 67005
Forest Investigative Site
Atlanta, Georgia, 30342
Forest Investigative Site
Austin, Texas, 78705
Forest Investigative Site
Bellevue, Washington, 98402
Forest Investigative Site
Bensalem, Pennsylvania, 19020
Forest Investigative Site
Birmingham, Alabama, 35205
Forest Investigative Site
Birmingham, Alabama, 35215
Forest Investigative Site
Bismarck, North Dakota, 58501
Forest Investigative Site
Boca Raton, Florida, 33486
Forest Investigative Site
Boston, Massachusetts, 02135
Forest Investigative Site
Boulder, Colorado, 80304
Forest Investigative Site
Bradenton, Florida, 34203
Forest Investigative Site
Brooklyn, New York, 11214
Forest Investigative Site
Brooksville, Florida, 34601
Forest Investigative Site
Burbank, California, 91505
Forest Investigative Site
Chandler, Arizona, 85225
Forest Investigative Site
Charlottesville, Virginia, 22911
Forest Investigative Site
Chaska, Minnesota, 55318
Forest Investigative Site
Chevy Chase, Maryland, 20815
Forest Investigative Site
Christianburg, Virginia, 24073
Forest Investigative Site
Cincinnati, Ohio, 45219
Forest Investigative Site
Cleveland, Ohio, 44122
Forest Investigative Site
Colorado Springs, Colorado, 80909
Forest Investigative Site
Dallas, Texas, 75234
Forest Investigative Sites
Denver, Colorado, 80205
Forest Investigative Site
Elkhart, Indiana, 46514
Forest Investigative Site
Encinitas, California, 92024
Forest Investigative Site
Evansville, Indiana, 47714
Forest Investigative Site
Fayetteville, North Carolina, 28304
Forest Investigative Site
Foothill Ranch, California, 92610
Forest Investigative Site
Fort Myers, Florida, 33916
Forest Investigative Site
Great Neck, New York, 11021
Forest Investigative Site
Great Neck, New York, 11023
Forest Investigative Site
Greensboro, North Carolina, 27403
Forest Investigative Site
Greenville, South Carolina, 29615
Forest Investigative Site
Greer, South Carolina, 29651
Forest Investigative Site
Hagerstown, Maryland, 21742
Forest Investigative Site
Hickory, North Carolina, 28601
Forest Investigative Site
Houston, Texas, 77090
Forest Investigative Site
Huntsville, Alabama, 35801
Forest Investigative Site
Idaho Falls, Idaho, 83404
Forest Investigative Site
Indianapolis, Indiana, 46237
Forest Investigative Site
Indianapolis, Indiana, 46254
Forest Investigative Site
Iowa City, Iowa, 52242
Forest Investigative Site
Jupiter, Florida, 33458
Forest Investigative Site
Kissimmee, Florida, 34741
Forest Investigative Site
Lake Jackson, Texas, 77566
Forest Investigative Site
Lakewood, Washington, 98499
Forest Investigative Site
Lexington, Kentucky, 40509
Forest Investigative Site
Longmont, Colorado, 80501
Forest Investigative Site
Los Angeles, California, 90036
Forest Investigative Site
Lutherville, Maryland, 21093
Forest Investigative Site
Madisonville, Kentucky, 42431
Forest Investigative Site
Marietta, Georgia, 30060
Forest Investigative Site
Marietta, Georgia, 30067
Forest Investigative Site
Mesa, Arizona, 85210
Forest Investigative Site
Miami, Florida, 33143
Forest Investigative Site
Milwaukee, Wisconsin, 53209
Forest Investigative Site
Nashville, Tennessee, 37205
Forest Investigative Site
Newport News, Virginia, 23606
Forest Investigative Site
Newton, Kansas, 67114
Forest Investigative Site
Norfolk, Virginia, 23502
Forest Investigative Site
Norfolk, Virginia, 23507
Forest Investigative Site
Ocala, Florida, 34471
Forest Investigative Site
Oklahoma City, Oklahoma, 73104
Forest Investigative Site
Orange, California, 92869
Forest Investigative Site
Orlando, Florida, 32806
Forest Investigative Site
Panama City, Florida, 32405
Forest Investigative Site
Pembroke Pines, Florida, 33024
Forest Investigative Site
Peoria, Arizona, 85381
Forest Investigative Site
Phoenix, Arizona, 85012
Forest Investigative Site
Pittsburgh, Pennsylvania, 15206
Forest Investigative Site
Raleigh, North Carolina, 27612
Forest Investigative Site
Richmond, Virginia, 23294
Forest Investigative Site
Rockford, Illinois, 61107
Forest Investigative Site
Salt Lake City, Utah, 84102
Forest Investigative Site
San Antonio, Texas, 78209
Forest Investigative Site
San Antonio, Texas, 78229
Forest Investigative Site
Scottsdale, Arizona, 85251
Forest Investigative Site
St Louis, Missouri, 63110
Forest Investigative Site
St Louis, Missouri, 63128
Forest Investigative Site
St. Petersburg, Florida, 33709
Forest Investigative Site
Stockbridge, Georgia, 30281
Forest Investigative Site
Tampa, Florida, 33606
Forest Investigative Site
Trinity, Florida, 34655
Forest Investigative Site
Tucson, Arizona, 85741
Forest Investigative Site
Tulsa, Oklahoma, 74135
Forest Investigative Site
Vineland, New Jersey, 08360
Forest Investigative Site
Waterbury, Connecticut, 06708
Forest Investigative Site
Wenatchee, Washington, 98801
Forest Investigative Site
Westlake Village, California, 91361
Forest Investigative Site
Wheat Ridge, Colorado, 80033
Forest Investigative Site
Wichita, Kansas, 67205
Forest Investigative Site
Wichita, Kansas, 67207
Forest Investigative Site
Wilmington, North Carolina, 28401
Forest Investigative Site
Winston-Salem, North Carolina, 27103
Forest Investigative Site
Woodstock, Georgia, 30189
Forest Investigative Site
Zephyrhills, Florida, 33542

Other trials in United States

Canada8 sites

Forest Investigative Site
Greater Sudbury, Ontario, P3E 1H5
Forest Investigative Site
Hamilton, Ontario, L8N 4A6
Forest Investigative Site
Newmarket, Ontario, L3Y 7V1
Forest Investigative Site
Ottawa, Ontario, K2c 3R2
Forest Investigative Site 1
Sarnia, Ontario, N7T 4X3
Forest Investigative Site 2
Sarnia, Ontario, N7T 4X3
Forest Investigative Site
Toronto, Ontario, MCN 2V7
Forest Investigative Site
Vancouver, British Columbia, V67 2K5

Other trials in Canada

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation

Conditions: Chronic Constipation
Being tested: Linaclotide 290 micrograms, Linaclotide 145 micrograms, Placebo
Keywords: Constipation, Chronic Constipation, Linaclotide
Medical subject headings: Constipation

What participants receive

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

Linaclotide 290 microgramsDrug
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Linaclotide 145 microgramsDrug
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
PlaceboDrug
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Study groups in NCT00765882
Study group	Role	What they receive
1	Experimental	Linaclotide 290 micrograms Receives: Drug: Linaclotide 290 micrograms
2	Experimental	Linaclotide 145 micrograms Receives: Drug: Linaclotide 145 micrograms
3	Placebo comparator	Matching placebo Receives: Drug: Placebo

What is being measured

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

Complete Spontaneous Bowel Movement (CSBM) Overall Responder
A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline.
A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.
An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
Measured: Change from Baseline to Week 12

Secondary outcomes (7)

12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
The number of CSBMs per week.
Measured: Change from Baseline to Week 12
12-Week Spontaneous Bowel Movement (SBM) Frequency Rate
A patient's 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.
Measured: Change from Baseline to Week 12
12-Week Stool Consistency
The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:
1. = separate hard lumps like nuts [difficult to pass]
2. = sausage shaped but lumpy
3. = like a sausage but with cracks on 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]
Measured: Change from Baseline to Week 12
12-Week Severity of Straining
Straining is measured on a 5-point scale, where a value of 1 is "not at all" and a value of 5 is "an extreme amount.
Measured: Change from Baseline to Week 12
12-Week Abdominal Discomfort
Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."
Measured: Change from Baseline to Week 12
12-Week Bloating
Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".
Measured: Change from Baseline to Week 12
12-Week Constipation Severity
Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe".
Measured: Change from Baseline to Week 12

Timeline

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

Sep 2008Aug 2009

First posted3 Oct 2008 (estimated)
Study startSep 2008
Primary completionJul 2009
Study completionAug 2009

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 (2)Papers the sponsor has linked to this study.
Other trials for Chronic 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: 633 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00765882
Sponsor's protocol ID: LIN-MD-01
Status last verified: Dec 2012
First submitted: 1 Oct 2008
Last updated: 30 Jan 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Chang L, Lembo AJ, Lavins BJ, Shiff SJ, Hao X, Chickering JG, Jia XD, Currie MG, Kurtz CB, Johnston JM. The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials. Aliment Pharmacol Ther. 2014 Dec;40(11-12):1302-12. doi: 10.1111/apt.12985. Epub 2014 Oct 13.
PubMed 25312449
Lembo AJ, Schneier HA, Shiff SJ, Kurtz CB, MacDougall JE, Jia XD, Shao JZ, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Eng P, Fox SM, Johnston JM. Two randomized trials of linaclotide for chronic constipation. N Engl J Med. 2011 Aug 11;365(6):527-36. doi: 10.1056/NEJMoa1010863.
PubMed 21830967

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

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
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)
Active, not recruiting
Footstool in Alleviating Symptoms of Evacuation Disorder
Pelvic Floor Dysfunc, Chronic Constipation
RecruitingObservational study
Indiana University Gastrointestinal Motility Diagnosis Registry
Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD)

All Chronic Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation
ClinicalTrials.gov ID: NCT00765882
Acronym / sponsor ID: LIN-MD-01
Conditions: Chronic Constipation
Keywords: Constipation, Chronic Constipation, Linaclotide
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 633 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Ironwood Pharmaceuticals, Inc.
Study start: Sep 2008
Primary completion: Jul 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 3 Oct 2008 (estimated)
Results: Posted 30 Jan 2013

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
1	Experimental	Drug: Linaclotide 290 microgramsLinaclotide 290 micrograms
2	Experimental	Drug: Linaclotide 145 microgramsLinaclotide 145 micrograms
3	Placebo comparator	Drug: PlaceboMatching placebo

Who may qualify

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

Key inclusion criteria (5 listed)

Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
Patient meets protocol criteria for CC: reports < 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
Patient demonstrates continued chronic constipation through Pretreatment Period
Patient is compliant with IVRS

Key exclusion criteria (4 listed)

Patient has history of loose or watery stools
Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

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
Linaclotide 290 microgramsOral, once daily each morning at least 30 minutes before breakfast for the duration of the study	Drug	1
Linaclotide 145 microgramsOral, once daily each morning at least 30 minutes before breakfast for the duration of the study	Drug	2
PlaceboOral, once daily each morning at least 30 minutes before breakfast for the duration of the study	Drug	3

Primary outcome

Complete Spontaneous Bowel Movement (CSBM) Overall Responder
Time frame: Change from Baseline to Week 12
A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation. An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

7 secondary outcomes

12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
Time frame: Change from Baseline to Week 12
12-Week Spontaneous Bowel Movement (SBM) Frequency Rate
Time frame: Change from Baseline to Week 12
12-Week Stool Consistency
Time frame: Change from Baseline to Week 12
12-Week Severity of Straining
Time frame: Change from Baseline to Week 12
12-Week Abdominal Discomfort
Time frame: Change from Baseline to Week 12
12-Week Bloating
Time frame: Change from Baseline to Week 12
12-Week Constipation Severity
Time frame: Change from Baseline to Week 12

Results and safety

Results posted to the registry on 30 Jan 2013, 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	215	191
Linaclotide 145µg	213	173
Linaclotide 290µg	205	169

Primary outcome: Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Time frame: Change from Baseline to Week 12. Number. Unit: participants

Measure	Placebo n = 215	Linaclotide 145µg n = 213	Linaclotide 290µg n = 202
Responder	13	34	43
Nonresponder	202	179	159

Placebo vs Linaclotide 145µg: Odds Ratio (OR): 2.93 (95% CI 1.50 to 5.72), p = 0.0012, Cochran-Mantel-Haenszel
Placebo vs Linaclotide 290µg: Odds Ratio (OR): 4.22 (95% CI 2.20 to 8.10), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event reporting occurred from October 2008 through August 2009.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 215 (1.9%)	35 of 215 (16.3%)	Not reported
Linaclotide 145µg	3 of 213 (1.4%)	70 of 213 (32.9%)	Not reported
Linaclotide 290µg	7 of 205 (3.4%)	49 of 205 (23.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25312449Chang L, Lembo AJ, Lavins BJ, Shiff SJ, Hao X, Chickering JG, Jia XD, Currie MG, Kurtz CB, Johnston JM. The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials. Aliment Pharmacol Ther. 2014 Dec;40(11-12):1302-12. doi: 10.1111/apt.12985. Epub 2014 Oct 13.
Derived from this study: PubMed 21830967Lembo AJ, Schneier HA, Shiff SJ, Kurtz CB, MacDougall JE, Jia XD, Shao JZ, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Eng P, Fox SM, Johnston JM. Two randomized trials of linaclotide for chronic constipation. N Engl J Med. 2011 Aug 11;365(6):527-36. doi: 10.1056/NEJMoa1010863.

Related trials for Chronic Constipation

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
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)
Active, not recruiting
Footstool in Alleviating Symptoms of Evacuation Disorder
Pelvic Floor Dysfunc, Chronic Constipation
RecruitingObservational study
Indiana University Gastrointestinal Motility Diagnosis Registry
Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD)

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.

Paul F.C. Eng, PhD study director

Forest Laboratories

108 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linaclotide 290 micrograms and Linaclotide 145 micrograms in people with Chronic Constipation, run by Forest Laboratories at 108 sites in 2 countries.

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 5 inclusion and 4 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 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Canada. 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 30 Jan 2013). 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?

Complete Spontaneous Bowel Movement (CSBM) Overall Responder (time frame: Change from Baseline to Week 12). 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 NCT00765882, which also lists 2 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 30 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.