A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2)

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Ardelyx

Status and phase

Completed
Phase 3

Conditions

Constipation Predominant Irritable Bowel Syndrome

Treatments

Drug: Placebo
Drug: Tenapanor

Study type

Interventional

Funder types

Industry

Identifiers

NCT02686138
TEN-01-302

Details and patient eligibility

About

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.

Full description

During the 26-week double-blind treatment period, subjects will record daily assessments including: frequency and timing of bowel movements; sensation of complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping; and use and timing of rescue medication. Subjects will also record weekly assessments including: adequate relief of IBS symptoms, degree of relief of IBS symptoms, IBS severity, and constipation severity.

Enrollment

593 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

593 participants in 2 patient groups, including a placebo group

50mg BID
Experimental group
Description:
Tenapanor, 50mg BID (100mg total)
Treatment:
Drug: Tenapanor
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

117

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Data sourced from clinicaltrials.gov

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