Irritable Bowel Syndrome With ConstipationPhase 3NCT00938717

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

A Phase 3 study of Irritable Bowel Syndrome With Constipation, run by Ironwood Pharmaceuticals, Inc. at 107 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 purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 805 participants
Where: 107 sitesUnited States
Study dates: Jul 2009to Sep 2010
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 diagnosis of IBS-C
Patient demonstrates continued IBS-C 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 a medical condition that may contribute to abdominal pain
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

107 sites in 1 country.

City, postcode or hospital

107 sites in 1 country

United States107 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, 06011
Ironwood Investigational Site
Bristol, Tennessee, 37620
Ironwood Investigational Site
Chapel Hill, North Carolina, 27599
Ironwood Investigational Site
Charleston, South Carolina, 29414
Ironwood Investigational Site
Charlotte, North Carolina, 28209
Ironwood Investigational Site
Charlotte, North Carolina, 28211
Ironwood Investigational Site
Chattanooga, Tennessee, 37404
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
Fort Worth, Texas, 76104
Ironwood Investigational Site
Garden Grove, California, 92840
Ironwood Investigational Site
Germantown, Tennessee, 38183
Ironwood Investigational Site
Greensboro, North Carolina, 27401
Ironwood Investigational Site
Greensboro, North Carolina, 27408
Ironwood Investigational Site
Harrisburg, North Carolina, 28075
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
Huntersville, North Carolina, 28078
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, 32205
Ironwood Investigational Site
Jacksonville, Florida, 32207
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
Lauderdale Lakes, Florida, 33319
Ironwood Investigational Site
Laurel, Maryland, 20707
Ironwood Investigational Site
Levittown, Pennsylvania, 19056
Ironwood Investigational Site
Longview, Texas, 75605
Ironwood Investigational Site
Lynchburg, Virginia, 24502
Ironwood Investigational Site
Marlton, New Jersey, 08053
Ironwood Investigational Site
Mentor, Ohio, 44060
Ironwood Investigational Site
Metairie, Louisiana, 70006
Ironwood Investigational Site
Miami, Florida, 33156
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
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, 85014
Ironwood Investigational Site
Pinellas Park, Florida, 33782
Ironwood Investigational Site
Pittsford, New York, 14534
Ironwood Investigational Site
Plymouth, Minnesota, 55446
Ironwood Investigational Site
Reading, Pennsylvania, 19606
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, 29581
Ironwood Investigational Site
Spokane, Washington, 99208
Ironwood Investigational Site
Statesville, North Carolina, 28625
Ironwood Investigational Site
Sugarland, Texas, 77479
Ironwood Investigational Site
Summerville, South Carolina, 29485
Ironwood Investigational Site
Sylvania, Ohio, 43560
Ironwood Investigational Site
Tampa, Florida, 33607
Ironwood Investigational Site
Tempe, Arizona, 85282
Ironwood Investigational Site
Topeka, Kansas, 66606
Ironwood Investigational Site
Traverse City, Michigan, 49684
Ironwood Investigational Site
Troy, Michigan, 48098
Ironwood Investigational Site
Tucson, Arizona, 85710
Ironwood Investigational Site
Tucson, Arizona, 85741
Ironwood Investigational Site
Tupelo, Mississippi, 38801
Ironwood Investigational Site
Vancouver, Washington, 98664
Ironwood Investigational Site
Wadsworth, Ohio, 44281
Ironwood Investigational Site
Washington, Pennsylvania, 15301
Ironwood Investigational Site
Winston-Salem, North Carolina, 27103
Ironwood Investigational Site
Yukon, Oklahoma, 73099

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 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation

The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).

Conditions: Irritable Bowel Syndrome With Constipation
Being tested: Linaclotide or Matching Placebo
Keywords: IBS

What participants receive

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

Linaclotide or Matching PlaceboDrug
Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial

Study groups in NCT00938717
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Linaclotide or Matching Placebo
290 μg Linaclotide	Experimental	Not described Receives: Drug: Linaclotide or Matching Placebo

What is being measured

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

Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks
A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.
The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.
SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation.
Measured: Change from Baseline to Week 12
Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks
A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.
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
Abdominal Pain Responder, 9 Out of 12 Weeks
A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.
The Abdominal Pain score assesses patient's worst abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Measured: Change from Baseline to Week 12
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks
A patient is considered to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.
The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.
SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation.
Measured: Change from Baseline to Week 12

Secondary outcomes (10)

12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency
The change from baseline in 12-week CSBM frequency (i.e., weekly CSBM frequency over the first 12 weeks of the Treatment Period).
Measured: Change from Baseline to Week 12
12-Week Spontaneous Bowl Movement (SBM) Frequency
The change from baseline in 12-week SBM frequency (i.e., weekly SBM frequency over the first 12 weeks of the Treatment Period).
Measured: Change from Baseline to Week 12
12-Week Change in Stool Consistency
The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.
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
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 Pain Score
Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Measured: Change from Baseline to Week 12
12-Week Change in Abdominal Discomfort
Abdominal discomfort was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".
Measured: Change from Baseline to Week 12
12-Week Change in Bloating
Bloating was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".
Measured: Change from Baseline to Week 12
Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment
A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.
Measured: Change from Baseline to Week 12
Abdominal Pain Responder for 6 Out of 12 Weeks
A patient is considered to be an AP responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had a decrease of at least 30 percent in their Abdominal Pain score from baseline during a particular week.
Measured: Change from Baseline to Week 12
12-Week Percent of Abdominal Pain-free Days
Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst.
Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
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.

Jul 2009Sep 2010

First posted14 Jul 2009 (estimated)
Study startJul 2009
Primary completionSep 2010
Study completionSep 2010

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 805 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00938717
Sponsor's protocol ID: MCP-103-302
Status last verified: Oct 2013
First submitted: 12 Jul 2009
Last updated: 5 Nov 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Rao SS, Quigley EM, Shiff SJ, Lavins BJ, Kurtz CB, MacDougall JE, Currie MG, Johnston JM. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.
PubMed 24075889
Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.
PubMed 23116208

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

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
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

All Irritable Bowel Syndrome With Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 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 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation
ClinicalTrials.gov ID: NCT00938717
Acronym / sponsor ID: MCP-103-302
Conditions: Irritable Bowel Syndrome With Constipation
Keywords: IBS
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 805 participants (actual)
Lead sponsor: Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Forest Laboratories
Study start: Jul 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 14 Jul 2009 (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 and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (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: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Linaclotide or Matching Placebo
290 μg Linaclotide	Experimental	Drug: Linaclotide or 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 diagnosis of IBS-C
Patient demonstrates continued IBS-C 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 a medical condition that may contribute to abdominal pain
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 or Matching PlaceboLinaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial	Drug	290 μg Linaclotide, Placebo

Primary outcome

Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks
Time frame: Change from Baseline to Week 12
A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation.
Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks
Time frame: Change from Baseline to Week 12
A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week. 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.
Abdominal Pain Responder, 9 Out of 12 Weeks
Time frame: Change from Baseline to Week 12
A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week. The Abdominal Pain score assesses patient's worst abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks
Time frame: Change from Baseline to Week 12
A patient is considered to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation.

10 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 Pain Score
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
Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment
Time frame: Change from Baseline to Week 12
Abdominal Pain Responder for 6 Out of 12 Weeks
Time frame: Change from Baseline to Week 12
12-Week Percent of Abdominal Pain-free Days
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	403	305
Linaclotide	402	294

Primary outcome: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks

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

Measure	Placebo n = 403	Linaclotide n = 401
Value	12	51

Placebo vs Linaclotide: Odds Ratio (OR): 4.65 (95% CI 2.44 to 8.84), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.

Primary outcome: Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks

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

Measure	Placebo n = 403	Linaclotide n = 401
Value	20	72

Placebo vs Linaclotide: Odds Ratio (OR): 4.19 (95% CI 2.50 to 7.03), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.

Primary outcome: Abdominal Pain Responder, 9 Out of 12 Weeks

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

Measure	Placebo n = 403	Linaclotide n = 401
Value	79	156

Placebo vs Linaclotide: Odds Ratio (OR): 2.62 (95% CI 1.91 to 3.60), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.

Primary outcome: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks

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

Measure	Placebo n = 403	Linaclotide n = 401
Value	56	135

Placebo vs Linaclotide: Odds Ratio (OR): 3.16 (95% CI 2.22 to 4.49), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from July of 2009 to September of 2010 (26 weeks of safety data were collected). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	7 of 403 (1.7%)	86 of 403 (21.3%)	Not reported
Linaclotide	4 of 402 (1%)	137 of 402 (34.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24075889Rao SS, Quigley EM, Shiff SJ, Lavins BJ, Kurtz CB, MacDougall JE, Currie MG, Johnston JM. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.
Derived from this study: PubMed 23116208Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.

Related trials for Irritable Bowel Syndrome With Constipation

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
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

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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Irritable Bowel Syndrome With Constipation, run by Ironwood Pharmaceuticals, Inc. at 107 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 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 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?

Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks (time frame: Change from Baseline to Week 12). The study lists 4 primary outcomes in all. 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 NCT00938717, 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 5 Nov 2013.