CompletedPhase 3

A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

United States614 participantsStarted 2018-06-20

Plain-language summary

To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Hormonal contraception
✓. Double-barrier birth control
✓. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy

What they're measuring

Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Throughout the Treatment Period

Timeframe: Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)

Trial details

NCT IDNCT03573908

SponsorIronwood Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03-13

Results submitted2020-10-19

View on ClinicalTrials.gov More Irritable Bowel Syndrome Characterized by Constipation trials