A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

Completed · Phase 3 · Has a placebo group

Conditions studied: Constipation Predominant Irritable Bowel Syndrome

In brief

This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of one dose 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 (1:1) for a 26 week treatment period.

Key facts

Study ID

NCT02686138

Run by

Ardelyx

People needed

593

Starts

2015-12-01

Expected to finish

2017-10-01

Last updated by the study team

2020-04-22

Who can join

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

You may qualify if…

• Males or females aged 18 to 75 years, inclusive
• 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 appropriate methods 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

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 or carcinoid syndrome.
• Potential CNS cause of constipation (e.g., Parkinson's disease, spinal cord injury, or multiple sclerosis)
• Subject has a history or current evidence of laxative abuse (in the clinical judgment of physician)
• Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal) or renal impairment (serum creatinine >2 mg/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 and cholecystectomy (unless within 60 days of screening visit)

Where it is running

• Ardelyx Investigative Site 200 — Foley, Alabama, United States
• Ardelyx Investigative Site 103 — Huntsville, Alabama, United States
• Ardelyx Investigative Site 244 — Huntsville, Alabama, United States
• Ardelyx Investigative Site 251 — Huntsville, Alabama, United States
• Ardelyx Investigative Site 100 — Huntsville, Alabama, United States
• Ardelyx Investigative Site 209 — Saraland, Alabama, United States
• Ardelyx Investigative Site 210 — Phoenix, Arizona, United States
• Ardelyx Investigative Site 296 — Phoenix, Arizona, United States
• Ardelyx Investigative Site 269 — Tucson, Arizona, United States
• Ardelyx Investigative Site 256 — Tucson, Arizona, United States
• Ardelyx Investigative Site 292 — Conway, Arkansas, United States
• Ardelyx Investigative Site 122 — Little Rock, Arkansas, United States
• Ardelyx Investigative Site 163 — Anaheim, California, United States
• Ardelyx Investigative Site 105 — Canoga Park, California, United States
• Ardelyx Investigative Site 143 — Chula Vista, California, United States
• Ardelyx Investigative Site 147 — Encino, California, United States
• Ardelyx Investigative Site 297 — La Mesa, California, United States
• Ardelyx Investigative Site 284 — La Mirada, California, United States
• Ardelyx Investigative Site 107 — Lomita, California, United States
• Ardelyx Investigative Site 165 — Long Beach, California, United States
• Ardelyx Investigative Site 211 — Orange, California, United States
• Ardelyx Investigative Site 233 — Wheat Ridge, Colorado, United States
• Ardelyx Investigative Site 212 — Bristol, Connecticut, United States
• Ardelyx Investigative Site 176 — Brandon, Florida, United States
• Ardelyx Investigative Site 257 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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