A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C

Completed · Phase 3 · Has a placebo group

Conditions studied: Constipation Predominant Irritable Bowel Syndrome

In brief

This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a two-week screening period. Subjects who qualify and are randomized into the study will either receive 50mg BID of tenapanor or placebo BID for 12 week treatment period and then undergo a 4 week placebo controlled randomized withdrawal.

Key facts

Study ID

NCT02621892

Run by

Ardelyx

People needed

606

Starts

2015-10-01

Expected to finish

2017-04-01

Last updated by the study team

2020-04-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 75 years old
• Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception.
• Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization
• Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS
• A colonoscopy based on AGA guidelines; every 10 years at ≥ 50 years old, or the occurrence of any warning signs

You may not qualify if…

• Functional diarrhea as defined by Rome III criteria
• IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria
• Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction, ischemic colitis or carcinoid syndrome.
• Subject has a history or current evidence of laxative abuse (in the clinical judgment of the physician)
• Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal) or renal impairment (serum creatinine > 2mg/dL)
• Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
• Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy (unless within 60 days of screening visit)

Where it is running

• Ardelyx Investigative Site 114 — Birmingham, Alabama, United States
• Ardelyx Investigative Site 103 — Huntsville, Alabama, United States
• Ardelyx Investigative Site 100 — Huntsville, Alabama, United States
• Ardelyx Investigative Site 145 — Chandler, Arizona, United States
• Ardelyx Investigative Site 210 — Phoenix, Arizona, United States
• Ardelyx Investigative Site 296 — Phoenix, Arizona, United States
• Ardelyx Investigative Site 277 — Tempe, Arizona, United States
• Ardelyx Investigative Site 269 — Tucson, Arizona, United States
• Ardelyx Investigative Site 187 — Tucson, Arizona, United States
• Ardelyx Investigative Site 199 — Tucson, Arizona, United States
• Ardelyx Investigative Site 140 — Harrisburg, Arkansas, United States
• Ardelyx Investigative Site 274 — Little Rock, Arkansas, United States
• Ardelyx Investigative Site 161 — Little Rock, Arkansas, United States
• Ardelyx Investigative Site 122 — Little Rock, Arkansas, United States
• Ardelyx Investigative Site 129 — North Little Rock, Arkansas, United States
• Ardelyx Investigative Site 105 — Canoga Park, California, United States
• Ardelyx Investigative Site 143 — Chula Vista, California, United States
• Ardelyx Investigative Site 146 — Encino, California, United States
• Ardelyx Investigative Site 147 — Encino, California, United States
• Ardelyx Investigative Site 107 — Lomita, California, United States
• Ardelyx Investigative Site 112 — North Hollywood, California, United States
• Ardelyx Investigative Site 110 — Northridge, California, United States
• Ardelyx Investigative Site 294 — San Diego, California, United States
• Ardelyx Investigative Site 108 — Thousand Oaks, California, United States
• Ardelyx Investigative Site 149 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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