Phase 3
Completed N=356
The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C)
Constipation Predominant Irritable Bowel Syndrome
Source: ClinicalTrials.gov NCT01923428 ↗
Enrolled (actual)
356
Serious AEs
1.1%
Results posted
Jan 2020
Primary outcomePrimary: Percent Complete Spontaneous Bowel Movement Responders vs Placebo — 35; 38; 51; 30 Participants — p=<0.001
◆ Published Evidence
Not yet cited
0citations
Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis.
Summary
This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of three dose levels of AZD1722 in subjects with constipation predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as determined during a two-week screening period. Subjects who qualify and are randomized into the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive weeks. At the end of this treatment period, subjects will be followed for an additional 4 weeks.
Linked Publications
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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 Percent Complete Spontaneous Bowel Movement Responders vs Placebo |
35; 38; 51; 30 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Females and males must agree to use appropriate methods of contraception or be sterile (with appropriate documentation)
- Subject is ambulatory
- Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS with a history of 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.
- Pregnant or lactating women.
- A major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other psychoses that has required hospitalization in the last 3 years. History of attempted suicide or uncontrolled bipolar disorder. Alcohol or substance abuse in the last year.
- Participation in other clinical trials within 1 month prior to Day -14 (beginning of screening period).
- If, in the opinion of the Investigator the subject is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable.
Data sourced from ClinicalTrials.gov (NCT01923428) 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.