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
| Status: | Completed |
|---|---|
| Conditions: | Constipation, Irritable Bowel Syndrome (IBS) |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/17/2019 |
| Start Date: | October 2015 |
| End Date: | April 2017 |
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)
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.
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.
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.
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.
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)
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