Phase 3
Completed N=606
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
Constipation Predominant Irritable Bowel Syndrome
Source: ClinicalTrials.gov NCT02621892 ↗
Enrolled (actual)
606
Serious AEs
1.0%
Results posted
Apr 2020
Primary outcomePrimary: 6 of 12 Week Overall Responder Rate — 83; 56 Participants — p=<0.02
◆ Published Evidence
Highly cited
102citations · ~17 / year
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1).
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.
Linked Publications (4)
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Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1).
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Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2).
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Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study.
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Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 of 12 Week Overall Responder Rate |
83; 56 | <0.02 sig |
| SECONDARY 6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate |
104; 88 | — |
| SECONDARY 6 of 12 Week Overall Abdominal Pain Responder Rate |
135; 99 | <0.008 sig |
| SECONDARY 9 of 12 Week Overall Responder Rate |
42; 10 | <0.001 sig |
| SECONDARY 9 of 12 Week Overall CSBM Responder Rate |
52; 15 | <0.001 sig |
| SECONDARY 9 of 12 Week Overall Abdominal Pain Responder Rate |
93; 58 | <0.003 sig |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02621892) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.