A Study to Assess the Safety, Tolerability and Clinical Activity of TD−1211 in Patients With Opioid-Induced Constipation
| Status: | Completed |
|---|---|
| Conditions: | Constipation |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/30/2019 |
| Start Date: | May 2011 |
| End Date: | June 2012 |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Clinical Activity of TD−1211 in Subjects With Opioid-Induced Constipation
A dose-escalation study to assess the safety, tolerability and clinical activity of TD−1211
in patients with opioid-induced constipation.
in patients with opioid-induced constipation.
Inclusion Criteria:
- Males and females between 18 and 65 years of age, inclusive
- Subjects with documented OIC on stable opioid regimen
- Willingness to stop all laxatives throughout run-in and treatment period
Exclusion Criteria:
- Any clinically significant findings in subjects with OIC
- Have participated in another clinical trial of an investigational drug 30 days prior
to screening
- History of chronic constipation prior to opioid therapy in OIC subjects
- Active medical disorders associated with diarrhea or intermittent loose stools in OIC
subjects
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