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

Phase 2

Completed

• Conditions: Opioid Induced Constipation
• Interventions: Drug: TD-1211; Drug: Placebo

• Registration Number: NCT01401985
• Lead Sponsor: Theravance Biopharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2011-10
• Primary Completion: 2012-05
• Study Completion: 2012-08
• Disposition First Submitted: 2013-06-05
• Disposition First Submitted QC: 2013-06-05
• Disposition First Posted: 2013-06-13
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 6	Placebo	2.5 mg TD-1211 every 6 hours for 14 days
Cohort 2	TD-1211	5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days
Cohort 1	TD-1211	5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days
Cohort 4	TD-1211	5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days
Cohort 6	TD-1211	2.5 mg TD-1211 every 6 hours for 14 days
Cohort 5	Placebo	2 mg TD-1211 once daily for 14 days
Cohort 5	TD-1211	2 mg TD-1211 once daily for 14 days
Cohort 3	TD-1211	5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of TD-1211	14 days

Secondary Outcome Measures

Name	Time	Method
Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)	Weekly assessments throughout Treatment Period	Change from baseline in the weekly SBM and CSBM frequency

Trial Locations

Locations (1)

Theravance Biopharma Investigational Site; 🇺🇸 Pasadena, California, United States