Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 839 people — 417 in the linaclotide group and 422 in the placebo group (a placebo is a dummy treatment with no active ingredient, used for comparison). The trial was measuring symptoms of Irritable Bowel Syndrome with Constipation (IBS-C), specifically looking at abdominal pain and discomfort, overall IBS symptom relief, and bowel movement patterns over 12 weeks. By the end of the study, 384 people in the linaclotide group and 367 in the placebo group had completed the trial. The reported data shows the following numbers for the two main (primary) measures. For abdominal pain and discomfort response — meaning at least a 30% improvement for at least 6 out of 12 weeks — 250 out of 417 participants in the linaclotide group met this threshold, compared with 206 out of 422 in the placebo group. For overall IBS symptom relief — meaning participants reported their symptoms as "considerably" or "completely" relieved for at least 6 out of 12 weeks — 132 out of 417 in the linaclotide group met this threshold, compared with 65 out of 422 in the placebo group. For the secondary measures, the reported data shows that bowel movements without laxatives (including those with a sense of complete emptying) increased more in the linaclotide group than the placebo group over 12 weeks. Stool consistency scores also changed more in the linaclotide group, and straining scores decreased slightly more in the linaclotide group (a decrease of 1.02 points on a 5-point scale) compared to the placebo group (a decrease of 0.69 points). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 35019221) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Irritable Bowel Syndrome Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have read, understood, and signed a consent form agreeing to take part in the study.
- You are not currently pregnant or breastfeeding, and you are willing to use birth control during the study.
- You meet the requirements for having a colonoscopy as set out by a major gastroenterology organisation, and your lab tests and physical exam show no significant health concerns.
- You have been diagnosed with Irritable Bowel Syndrome with Constipation (IBS-C) and meet specific criteria related to how often you go to the toilet, how hard you strain, the texture of your stools, and the level of stomach pain or discomfort you experience.
- You are willing to regularly complete a daily electronic diary as required by the study, and you agree not to make any major lifestyle changes that could affect your IBS-C symptoms during the trial.
Who may not be able to join:
- You have recently had loose, mushy, or watery stools on a regular basis.
- You have certain medical conditions, a relevant personal medical history, or a family medical history that would make you unsuitable for this study (confirm with trial site for specifics).
- You are currently experiencing unexplained and significant warning symptoms, or signs of infection or inflammation of the bowel.
- You have had surgery on your digestive tract at any point.
- You are currently taking medications that are not allowed during this trial (confirm with trial site for the specific list).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Yunsheng Yang, Chinese PLA General Hospital
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
12-week Abdominal Pain/Abdominal Discomfort Weekly Responder; 12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.