A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 9/15/2018 |
Start Date: | October 2011 |
End Date: | August 2012 |
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects With Opioid-Induced Constipation
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects
with Opioid-Induced Constipation
with Opioid-Induced Constipation
Inclusion Criteria:
- stable dose of opioids for at least 12 weeks before screening visit
- less than or equal to 5 spontaneous bowel movements for a 2 week period and
experiencing at least one other symptom of constipation
- willing to stop laxatives and other bowel treatments; rescue laxative allowed
Exclusion Criteria:
- Clinically significant condition or illness (other than the condition for which the
pain medication was prescribed)
- Have participated in another clinical trial of an investigational drug 30 days prior
to screening
- History of cancer treatment except adequately treated localized skin cancer within 5
years of screening
- History of chronic constipation prior to opioid therapy
- Females who are pregnant or breast feeding
- Have any condition that may affect drug absorption (e.g. previous GI surgery)
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