Irritable Bowel Syndrome With ConstipationPhase 2NCT00460811

Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

A Phase 2 study testing Linaclotide Acetate in people with Irritable Bowel Syndrome With Constipation, run by Ironwood Pharmaceuticals, Inc. at 85 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 purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Irritable Bowel Syndrome With Constipation
What is being tested?: Linaclotide Acetate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 420 participants
Where: 85 sitesin 2 countries
Study dates: Apr 2007to Apr 2008
Phase: Phase 2
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

Must not be pregnant or breastfeeding and agree to use birth control;
Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
Demonstrates English fluency and has access to a touch-tone telephone.

Who cannot join

Recent history of mushy or watery stools;
Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study;
Clinically-significant alarm symptoms;
Secondary causes of constipation or evacuation disorders;
Surgery to the gastrointestinal tract;
Usage of prohibited medications.

Trial locations and contacts

85 sites in 2 countries.

Country

City, postcode or hospital

85 sites in 2 countries

United States79 sites

Microbia Investigational Site
Anaheim, California
Microbia Investigational Site
Anderson, South Carolina
Microbia Investigational Site
Ann Arbor, Michigan
Microbia Investigational Site
Annapolis, Maryland
Microbia Investigational Site
Asheville, North Carolina
Microbia Investigational Site
Baton Rouge, Louisiana
Microbia Investigational Site
Beaumont, Texas
Microbia Investigational Site
Blackwood, New Jersey
Microbia Investigational Site
Boynton Beach, Florida
Microbia Investigational Site
Bristol, Connecticut
Microbia Investigational Site
Bristol, Tennessee
Microbia Investigational Site
Chandler, Arizona
Microbia Investigational Site
Chapel Hill, North Carolina
Microbia Investigational Site
Charleston, West Virginia
Microbia Investigational Site
Chesapeake, Virginia
Microbia Investigational Site
Cincinnati, Ohio
Microbia Investigational Site
Cleveland, Ohio
Microbia Investigational Site
Clive, Iowa
Microbia Investigational Site
Corsicana, Texas
Microbia Investigational Site
Davenport, Iowa
Microbia Investigational Site
Dayton, Ohio
Microbia Investigational Site
Dunedin, Florida
Microbia Investigational Site
El Paso, Texas
Microbia Investigational Site
Elkin, North Carolina
Microbia Investigational Site
Fall River, Massachusetts
Microbia Investigational Site
Garden Grove, California
Microbia Investigational Site
Germantown, Tennessee
Microbia Investigational Site
Great Neck, New York, 11020
Microbia Investigational Site
Greensboro, North Carolina
Microbia Investigational Site
Harrisburg, North Carolina
Microbia Investigational Site
Henderson, Nevada
Microbia Investigational Site
Hickory, North Carolina
Microbia Investigational Site
Huntsville, Alabama, 35801
Microbia Investigational Site
Jackson, Tennessee
Microbia Investigational Site
Kingsport, Tennessee
Microbia Investigational Site
La Crosse, Wisconsin
Microbia Investigational Site
Lakewood, Washington
Microbia Investigational Site
Largo, Florida
Microbia Investigational Site
Las Vegas, Nevada
Microbia Investigational Site
Levittown, Pennsylvania
Microbia Investigational Site
Libertyville, Illinois
Microbia Investigational Site
Lynchburg, Virginia
Microbia Investigational Site
Medford, Oregon
Microbia Investigational Site
Mission, Kansas
Microbia Investigational Site
Missoula, Montana
Microbia Investigational Site
Monroe, Louisiana, 71201
Microbia Investigational Site
Mt. Pleasant, South Carolina
Microbia Investigational Site
Ocala, Florida
Microbia Investigational Site
Ogden, Utah
Microbia Investigational Site
Oklahoma City, Oklahoma
Microbia Investigational Site
Olympia, Washington
Microbia Investigational Site
Peoria, Illinois, 60601
Microbia Investigational Site
Pittsburgh, Pennsylvania
Microbia Investigational Site
Pittsford, New York
Microbia Investigational Site
Port Orange, Florida
Microbia Investigational Site
Raleigh, North Carolina
Microbia Investigational Site
Reading, Pennsylvania
Microbia Investigational Site
Richmond, Virginia
Microbia Investigational Site
Sacramento, California
Microbia Investigational Site
San Antonio, Texas
Microbia Investigational Site
San Diego, California
Microbia Investigational Site
Sellersville, Pennsylvania, 18960
Microbia Investigational Site
Shawnee, Kansas
Microbia Investigational Site
Sherwood, Arkansas
Microbia Investigational Site
Silver Spring, Maryland
Microbia Investigational Site
Simpsonville, South Carolina
Microbia Investigational Site
St Louis, Missouri
Microbia Investigational Site
Statesville, North Carolina
Microbia Investigational Site
Stockbridge, Georgia
Microbia Investigational Site
Stuart, Florida
Microbia Investigational Site
Summerville, South Carolina
Microbia Investigational Site
Sylvania, Ohio
Microbia Investigational Site
Tampa, Florida, 33607
Microbia Investigational Site
Tulsa, Oklahoma
Microbia Investigational Site
Tuscon, Arizona
Microbia Investigational Site
Vancouver, Washington
Microbia Investigational Site
West Monroe, Louisiana
Microbia Investigational Site
Winston-Salem, North Carolina
Microbia Investigational Site
Yukon, Oklahoma

Other trials in United States

Canada6 sites

Microbia Investigational Site
Abbortsford, British Columbia
Microbia Investigational Site
Guelph, Ontario
Microbia Investigational Site
Milton, Ontario
Microbia Investigational Site
Saskatoon, Saskatchewan
Microbia Investigational Site
Toronto, Ontario
Microbia Investigational Site
Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-design, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Irritable Bowel Syndrome With Constipation

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Conditions: Irritable Bowel Syndrome With Constipation
Being tested: Linaclotide Acetate, Matching placebo
Keywords: Irritable Bowel Syndrome with Constipation, IBS, Irritable Bowel Syndrome, linaclotide acetate, linaclotide, MD-1100
Medical subject headings: Irritable Bowel Syndrome

What participants receive

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

Linaclotide AcetateDrug
Oral, once daily
Matching placeboDrug
Oral, once daily

Study groups in NCT00460811
Study group	Role	What they receive
72 ug linaclotide acetate	Active comparator	Not described Receives: Drug: Linaclotide Acetate
145 ug linaclotide acetate	Active comparator	Not described Receives: Drug: Linaclotide Acetate
290 ug linaclotide acetate	Active comparator	Not described Receives: Drug: Linaclotide Acetate
579 ug linaclotide acetate	Active comparator	Not described Receives: Drug: Linaclotide Acetate
Matching Placebo	Placebo comparator	Not described Receives: Drug: Matching placebo

What is being measured

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

Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period
The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period.
The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours.
Measured: Change from Baseline to Week 12

Secondary outcomes (6)

CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
For each week of the Treatment and Posttreatment Periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥ 4 days of IVRS questions, 2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from the baseline weekly CSBM rate.
Measured: Change from Baseline to Week 12
Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period
SBMs were measured daily during the treatment period by patient calls to the IVRS.
Measured: Change from Baseline to Week 12
Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period
Stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 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; and 7 = watery, no solid pieces (entirely liquid).
Measured: Change from Baseline to Week 12
Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period
Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.
Measured: Change from Baseline to Week 12
Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period
Patients provided a weekly assessment of Degree of Relief of IBS Symptoms using a 7-point balanced scale (1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse, 7=as bad as I can imagine).
Measured: Change from Baseline to Week 12
Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period
During the study, patients provided their self assessment of abdominal pain using a 5-point ordinal scale (1=none, 2=mild, 3=moderate, 4=severe, 5=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.

Apr 2007Apr 2008

First posted16 Apr 2007 (estimated)
Study startApr 2007
Primary completionFeb 2008
Study completionApr 2008

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 Irritable Bowel Syndrome With 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00460811
Sponsor's protocol ID: MCP-103-202
Status last verified: Jan 2013
First submitted: 13 Apr 2007
Last updated: 4 Feb 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Lembo A, Kuo B, Boinpally R, Li E, Mallick M, Bochenek W, Bartolini W. Randomised clinical trial: effects of MD-7246 on irritable bowel syndrome with diarrhoea. Aliment Pharmacol Ther. 2023 Jan;57(2):192-204. doi: 10.1111/apt.17274. Epub 2022 Nov 2.
PubMed 36324245
Johnston JM, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, O'Dea C, Baird M, Lembo AJ. Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation. Gastroenterology. 2010 Dec;139(6):1877-1886.e2. doi: 10.1053/j.gastro.2010.08.041. Epub 2010 Aug 27.
PubMed 20801122

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

Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2/3
Home Transcutaneous Electrical Acustimulation (TEA)
Irritable Bowel Syndrome With Constipation
Recruiting
A Study of Virtual Reality and Linaclotide for IBS-C
Irritable Bowel Syndrome With Constipation
RecruitingObservational study
Single-center Exploratory Study of the Intestinal Microbiota in Patients Treated for Irritable Bowel Syndrome With Predominant Constipation and Methane Production
Irritable Bowel Syndrome

All Irritable Bowel Syndrome With Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-design, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Irritable Bowel Syndrome With Constipation
ClinicalTrials.gov ID: NCT00460811
Acronym / sponsor ID: MCP-103-202
Conditions: Irritable Bowel Syndrome With Constipation
Keywords: Irritable Bowel Syndrome with Constipation, IBS, Irritable Bowel Syndrome, linaclotide acetate, linaclotide, MD-1100
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 420 participants (actual)
Lead sponsor: Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Feb 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 16 Apr 2007 (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.

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
72 ug linaclotide acetate	Active comparator	Drug: Linaclotide Acetate
145 ug linaclotide acetate	Active comparator	Drug: Linaclotide Acetate
290 ug linaclotide acetate	Active comparator	Drug: Linaclotide Acetate
579 ug linaclotide acetate	Active comparator	Drug: Linaclotide Acetate
Matching Placebo	Placebo comparator	Drug: Matching placebo

Who may qualify

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

Key inclusion criteria (4 listed)

Must not be pregnant or breastfeeding and agree to use birth control;
Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
Demonstrates English fluency and has access to a touch-tone telephone.

Key exclusion criteria (6 listed)

Recent history of mushy or watery stools;
Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study;
Clinically-significant alarm symptoms;
Secondary causes of constipation or evacuation disorders;
Surgery to the gastrointestinal tract;

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 AcetateOral, once daily	Drug	145 ug linaclotide acetate, 290 ug linaclotide acetate, 579 ug linaclotide acetate, 72 ug linaclotide acetate
Matching placeboOral, once daily	Drug	Matching Placebo

Primary outcome

Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period
Time frame: Change from Baseline to Week 12
The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period. The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours.

6 secondary outcomes

CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
Time frame: Change from Baseline to Week 12
Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period
Time frame: Change from Baseline to Week 12
Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period
Time frame: Change from Baseline to Week 12
Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period
Time frame: Change from Baseline to Week 12
Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period
Time frame: Change from Baseline to Week 12
Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period
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
72 μg Linaclotide Acetate	79	63
145 μg Linaclotide Acetate	82	67
290 μg Linaclotide Acetate	85	71
579 μg Linaclotide Acetate	89	71
Matching Placebo	85	65

Primary outcome: Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period

Time frame: Change from Baseline to Week 12. Least squares mean (Standard Error). Unit: CSBMs per week

Measure	72 ug Linaclotide Acetate n = 79	145 ug Linaclotide Acetate n = 82	290 ug Linaclotide Acetate n = 84	579 ug Linaclotide Acetate n = 89	Matching Placebo n = 85
Value	2.90 (0.385)	2.49 (0.380)	3.61 (0.372)	2.68 (0.369)	1.01 (0.372)

72 ug Linaclotide Acetate vs Matching Placebo: p = 0.0002, ANCOVA
145 ug Linaclotide Acetate vs Matching Placebo: p = 0.0036, ANCOVA
290 ug Linaclotide Acetate vs Matching Placebo: p <0.0001, ANCOVA

Population analysed: The Intent-to-treat (ITT) Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from March of 2007 to April 2008.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
72 µg Linaclotide Acetate	0 of 79 (0%)	21 of 79 (26.6%)	Not reported
145 µg Linaclotide Acetate	0 of 82 (0%)	23 of 82 (28%)	Not reported
290 µg Linaclotide Acetate	1 of 85 (1.2%)	26 of 85 (30.6%)	Not reported
579 µg Linaclotide Acetate	0 of 89 (0%)	30 of 89 (33.7%)	Not reported
Matching Placebo	0 of 85 (0%)	17 of 85 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36324245Lembo A, Kuo B, Boinpally R, Li E, Mallick M, Bochenek W, Bartolini W. Randomised clinical trial: effects of MD-7246 on irritable bowel syndrome with diarrhoea. Aliment Pharmacol Ther. 2023 Jan;57(2):192-204. doi: 10.1111/apt.17274. Epub 2022 Nov 2.
Derived from this study: PubMed 20801122Johnston JM, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, O'Dea C, Baird M, Lembo AJ. Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation. Gastroenterology. 2010 Dec;139(6):1877-1886.e2. doi: 10.1053/j.gastro.2010.08.041. Epub 2010 Aug 27.

Related trials for Irritable Bowel Syndrome With Constipation

Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2/3
Home Transcutaneous Electrical Acustimulation (TEA)
Irritable Bowel Syndrome With Constipation
Recruiting
A Study of Virtual Reality and Linaclotide for IBS-C
Irritable Bowel Syndrome With Constipation
RecruitingObservational study
Single-center Exploratory Study of the Intestinal Microbiota in Patients Treated for Irritable Bowel Syndrome With Predominant Constipation and Methane Production
Irritable Bowel Syndrome

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.

Microbia Medical Director, MD study director

Microbia, Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Linaclotide Acetate in people with Irritable Bowel Syndrome With Constipation, run by Ironwood Pharmaceuticals, Inc. at 85 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 4 inclusion and 6 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period (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 NCT00460811, 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 4 Feb 2013.