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

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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


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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