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 (T3MPO-1)

• ClinicalTrials.gov Identifier: NCT02621892
• Recruitment Status: Completed
• First Posted: December 4, 2015
• Last Update Posted: March 15, 2019
• Sponsor: Ardelyx
• Information provided by (Responsible Party): Ardelyx

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Constipation Predominant Irritable Bowel Syndrome	Drug: Tenapanor; Drug: Placebo	Phase 3

Detailed Description:

During the 12-week treatment period, subjects will record daily assessments including: frequency and timing of bowel movements; sensation and complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping. Subjects will also record weekly assessments including: adequate relief of IBS severity, and constipation severity.

At the end of the 12-week treatment period, there will be a 4-week randomized withdrawal period in which subjects who complete the study in Tenapanor group will be randomized to either Tenapanor 50mg BID or placebo BID (1:1) and subjects who complete the study in the placebo group will be assigned to receive Tenapanor 50mg BID.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 629 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
• Study Start Date: October 2015
• Actual Primary Completion Date: March 2017
• Actual Study Completion Date: April 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 50mg BID; Tenapanor	Drug: Tenapanor; Other Name: RDX5791, AZD1722
Placebo Comparator: Placebo; Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. 6 of 12 Week Overall Responder Rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. 6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate [ Time Frame: 12 weeks ]
2. 6 of 12 Week Overall Abdominal Pain Responder Rate [ Time Frame: 12 weeks ]
3. 9 of 12 Week Overall Responder Rate [ Time Frame: 12 weeks ]
4. 9 of 12 Week Overall CSBM Responder Rate [ Time Frame: 12 weeks ]
5. 9 of 12 Week Overall Abdominal Pain Responder Rate [ Time Frame: 12 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

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, 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)

Contacts and Locations

  Show 111 Study Locations

Sponsors and Collaborators

Ardelyx

Investigators

• Study Chair: David P Rosenbaum, Ph.D.; Ardelyx, Inc.

More Information

• Responsible Party: Ardelyx
• ClinicalTrials.gov Identifier: NCT02621892 History of Changes
• Other Study ID Numbers: TEN-01-301
• First Posted: December 4, 2015
• Last Update Posted: March 15, 2019
• Last Verified: March 2019

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Constipation; Disease; Pathologic Processes; Signs and Symptoms, Digestive; Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases