Chronic ConstipationPhase 3NCT00730015

Trial of Linaclotide in Patients With Chronic Constipation

A Phase 3 study testing Linaclotide in people with Chronic Constipation, run by Ironwood Pharmaceuticals, Inc. at 105 sites in United States.

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 dosing 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 643 participants
Where: 105 sitesUnited States
Study dates: Aug 2008to Oct 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

105 sites in 1 country.

City, postcode or hospital

105 sites in 1 country

United States105 sites

Ironwood Investigational Site
Albuquerque, New Mexico, 87108
Ironwood Investigational Site
Anaheim, California, 92801
Ironwood Investigational Site
Anderson, Indiana, 46011
Ironwood Investigational Site
Anderson, South Carolina, 29621
Ironwood Investigational Site
Annapolis, Maryland, 21401
Ironwood Investigational Site
Asheboro, North Carolina, 27203
Ironwood Investigational Site
Asheville, North Carolina, 28801
Ironwood Investigational Site
Baltimore, Maryland, 21215
Ironwood Investigational Site
Baton Rouge, Louisiana, 70809
Ironwood Investigational Site
Beachwood, Ohio, 44122
Ironwood Investigational Site
Beaumont, Texas, 77701
Ironwood Investigational Site
Birmingham, Alabama, 35209
Ironwood Investigational Site
Boynton Beach, Florida, 33426
Ironwood Investigational Site
Bristol, Connecticut, 06010
Ironwood Investigational Site
Bristol, Tennessee, 37620
Ironwood Investigational Site
Cedar Knolls, New Jersey, 07927
Ironwood Investigational Site
Chandler, Arizona, 85224
Ironwood Investigational Site
Chapel Hill, North Carolina, 27599
Ironwood Investigational Site
Charleston, South Carolina, 29414
Ironwood Investigational Site
Charlotte, North Carolina, 28211
Ironwood Investigational Site
Chattanooga, Tennessee, 37421
Ironwood Investigational Site
Chesapeake, Virginia, 23320
Ironwood Investigational Site
Chesterfield, Michigan, 48047
Ironwood Investigational Site
Chula Vista, California, 91910
Ironwood Investigational Site
Cincinnati, Ohio, 45224
Ironwood Investigational Site
Cincinnati, Ohio, 45242
Ironwood Investigational Site
Clive, Iowa, 50325
Ironwood Investigational Site
Colorado Springs, Colorado, 80904
Ironwood Investigational Site
Davenport, Iowa, 52807
Ironwood Investigational Site
Dayton, Ohio, 45440
Ironwood Investigational Site
El Paso, Texas, 79905
Ironwood Investigational Site
Encinitas, California, 92024
Ironwood Investigational Site
Garden Grove, California, 92840
Ironwood Investigational Site
Germantown, Tennessee, 38138
Ironwood Investigational Site
Greensboro, North Carolina, 27408
Ironwood Investigational Site
Harrisburg, North Carolina, 28075
Ironwood Investigational Site
Henderson, Nevada, 89104
Ironwood Investigational Site
Hickory, North Carolina, 28602
Ironwood Investigational Site
Hollywood, Florida, 33021
Ironwood Investigational Site
Hollywood, Maryland, 20636
Ironwood Investigational Site
Houston, Texas, 77024
Ironwood Investigational Site
Huntsville, Alabama, 35801
Ironwood Investigational Site
Inverness, Florida, 34452
Ironwood Investigational Site
Irving, Texas, 75061
Ironwood Investigational Site
Jackson, Mississippi, 39202
Ironwood Investigational Site
Jacksonville, Florida, 32256
Ironwood Investigational Site
Jacksonville, North Carolina, 28546
Ironwood Investigational Site
Jefferson City, Missouri, 65109
Ironwood Investigational Site
Kingsport, Tennessee, 37660
Ironwood Investigational Site
La Crosse, Wisconsin, 54601
Ironwood Investigational Site
Laguna Hills, California, 92653
Ironwood Investigational Site
Lancaster, Pennsylvania, 17604
Ironwood Investigational Site
Lancaster, Pennsylvania, 19606
Ironwood Investigational Site
Las Vegas, Nevada, 89128
Ironwood Investigational Site
Laurel, Maryland, 20707
Ironwood Investigational Site
Levittown, Pennsylvania, 19056
Ironwood Investigational Site
Longview, Texas, 75605
Ironwood Investigational Site
Los Angeles, California, 90045
Ironwood Investigational Site
Lynchburg, Virginia, 24502
Ironwood Investigational Site
Marlton, New Jersey, 08053
Ironwood Investigational Site
Milwaukee, Wisconsin, 53215
Ironwood Investigational Site
Mineola, New York, 11501
Ironwood Investigational Site
Mission, Kansas, 66202
Ironwood Investigational Site
Monroe, Louisiana, 71201
Ironwood Investigational Site
Nashville, Tennessee, 37203
Ironwood Investigational Site
New Bern, North Carolina, 28562
Ironwood Investigational Site
Newnan, Georgia, 30263
Ironwood Investigational Site
Ocean City, New Jersey, 07712
Ironwood Investigational Site
Ogden, Utah, 84405
Ironwood Investigational Site
Oklahoma City, Oklahoma, 73116
Ironwood Investigational Site
Orange, California, 92868
Ironwood Investigational Site
Overland Park, Kansas, 66215
Ironwood Investigational Site
Peoria, Illinois, 61602
Ironwood Investigational Site
Phoenix, Arizona, 85020
Ironwood Investigational Site
Pittsburgh, Pennsylvania, 15213
Ironwood Investigational Site
Pittsford, New York, 14534
Ironwood Investigational Site
Port Orange, Florida, 32129
Ironwood Investigational Site
Sacramento, California, 95830
Ironwood Investigational Site
Salt Lake City, Utah, 84107
Ironwood Investigational Site
San Antonio, Texas, 78229
Ironwood Investigational Site
San Carlos, California, 94070
Ironwood Investigational Site
San Diego, California, 92103
Ironwood Investigational Site
San Diego, California, 92108
Ironwood Investigational Site
San Diego, California, 92123
Ironwood Investigational Site
Sellersville, Pennsylvania, 18960
Ironwood Investigational Site
Sherwood, Arkansas, 72120
Ironwood Investigational Site
Shreveport, Louisiana, 71103
Ironwood Investigational Site
Simpsonville, South Carolina, 29681
Ironwood Investigational Site
Spokane, Washington, 99208
Ironwood Investigational Site
Statesville, North Carolina, 28625
Ironwood Investigational Site
Summerville, North Carolina, 29485
Ironwood Investigational Site
Sylvania, Ohio, 43560
Ironwood Investigational Site
Tampa, Florida, 33607
Ironwood Investigational Site
Topeka, Kansas, 66606
Ironwood Investigational Site
Traverse City, Michigan, 49684
Ironwood Investigational Site
Troy, Michigan, 48098
Ironwood Investigational Site
Tucson, Arizona, 85715
Ironwood Investigational Site
Tupelo, Mississippi, 38801
Ironwood Investigational Site
Tuscon, Arizona, 85710
Ironwood Investigational Site
Vancouver, Washington, 98664
Ironwood Investigational Site
Wadsworth, Ohio, 44281
Ironwood Investigational Site
Wilmington, North Carolina, 28401
Ironwood Investigational Site
Winston-Salem, North Carolina, 27103
Ironwood Investigational Site
Yukon, Oklahoma, 73099
Ironwood Investigational Site
Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Chronic Constipation

Conditions: Chronic Constipation
Being tested: Matching Placebo, Linaclotide

What participants receive

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

Matching PlaceboDrug
Oral, once daily
LinaclotideDrug
Oral, once daily

Study groups in NCT00730015
Study group	Role	What they receive
145 μg linaclotide	Experimental	Not described Receives: Drug: Linaclotide
290 μg linaclotide	Experimental	Not described Receives: Drug: Linaclotide
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.

Complete Spontaneous Bowel Movement (CSBM) Overall Responder
A 12-week CSBM Overall Responder 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
The number of CSBMs per week.
Measured: Change from Baseline to Week 12
12-Week Spontaneous Bowl Movement (SBM) Frequency
The number of SBMs per week.
Measured: Change from Baseline to Week 12
12-week Change in 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 Change in Severity of Straining
Severity of 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 Change in 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 Change in 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 Change in 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.

Aug 2008Oct 2009

First posted8 Aug 2008 (estimated)
Study startAug 2008
Primary completionAug 2009
Study completionOct 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: 643 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00730015
Sponsor's protocol ID: MCP-103-303
Status last verified: Dec 2012
First submitted: 5 Aug 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 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)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced 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
RecruitingPhase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Constipation

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 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Chronic Constipation
ClinicalTrials.gov ID: NCT00730015
Acronym / sponsor ID: MCP-103-303
Conditions: Chronic Constipation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 643 participants (actual)
Lead sponsor: Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Forest Laboratories
Study start: Aug 2008
Primary completion: Aug 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 8 Aug 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
145 μg linaclotide	Experimental	Drug: Linaclotide
290 μg linaclotide	Experimental	Drug: Linaclotide
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 (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
Matching PlaceboOral, once daily	Drug	Matching Placebo
LinaclotideOral, once daily	Drug	145 μg linaclotide, 290 μg linaclotide

Primary outcome

Complete Spontaneous Bowel Movement (CSBM) Overall Responder
Time frame: Change from Baseline to Week 12
A 12-week CSBM Overall Responder 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
Time frame: Change from Baseline to Week 12
12-Week Spontaneous Bowl Movement (SBM) Frequency
Time frame: Change from Baseline to Week 12
12-week Change in Stool Consistency
Time frame: Change from Baseline to Week 12
12-week Change in Severity of Straining
Time frame: Change from Baseline to Week 12
12-week Change in Abdominal Discomfort
Time frame: Change from Baseline to Week 12
12-week Change in Bloating
Time frame: Change from Baseline to Week 12
12-week Change in 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
Linaclotide, 145μg	217	186
Linaclotide, 290μg	217	177
Placebo	209	177

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

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

Measure	Linaclotide, 145μg n = 217	Linaclotide, 290μg n = 216	Placebo n = 209
Value	46	42	7

Linaclotide, 145μg vs Placebo: Odds Ratio (OR): 7.72 (95% CI 3.41 to 17.47), p <0.0001, Cochran-Mantel-Haenszel
Linaclotide, 290μg vs Placebo: Odds Ratio (OR): 7.21 (95% CI 3.14 to 16.59), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: 643 randomized patients received at least 1 dose of study drug. 642 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 data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Linaclotide 145μg	3 of 217 (1.4%)	27 of 217 (12.4%)	Not reported
Linaclotide 290μg	4 of 217 (1.8%)	30 of 217 (13.8%)	Not reported
Placebo	5 of 209 (2.4%)	14 of 209 (6.7%)	Not reported
Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period	0 of 177 (0%)	20 of 177 (11.3%)	Not reported
Linaclotide 145μg to Placebo RW Period	2 of 95 (2.1%)	1 of 95 (1.1%)	Not reported
Linaclotide 145μg to Linaclotide 145μg RW Period	0 of 90 (0%)	2 of 90 (2.2%)	Not reported
Linaclotide 290μg to Placebo RW Period	0 of 86 (0%)	0 of 86 (0%)	Not reported
Linaclotide 290μg to Linaclotide 290μg RW Period	0 of 90 (0%)	1 of 90 (1.1%)	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 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)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced 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
RecruitingPhase 4
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Constipation

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.

Jeffrey M. Johnston, MD, FACP study chair

Ironwood Pharmaceuticals, Inc.

105 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 Linaclotide in people with Chronic Constipation, run by Ironwood Pharmaceuticals, Inc. at 105 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 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 105 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 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 NCT00730015, 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.