A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)

Opioid Induced Constipation Clinical Trial

Official title:

A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects With Opioid-Induced Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401985
• Other study ID #: TD-1211-0076
• Status: Completed
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: May 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constipation
• Opioid Induced Constipation

Intervention

Drug:
• TD-1211
Capsules
• Placebo
Capsules

Locations

Country	Name	City	State
United States	Theravance Biopharma Investigational Site	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of TD-1211		14 days
Secondary	Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)	Change from baseline in the weekly SBM and CSBM frequency	Weekly assessments throughout Treatment Period