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

Sponsor

Theravance Biopharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01401985

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Opioid Induced Constipation	Drug: TD-1211 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days	Drug: TD-1211 Capsules
Experimental: Cohort 2 5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days	Drug: TD-1211 Capsules
Experimental: Cohort 3 5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days	Drug: TD-1211 Capsules
Experimental: Cohort 4 5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days	Drug: TD-1211 Capsules
Experimental: Cohort 5 2 mg TD-1211 once daily for 14 days	Drug: TD-1211 Capsules Drug: Placebo Capsules
Experimental: Cohort 6 2.5 mg TD-1211 every 6 hours for 14 days	Drug: TD-1211 Capsules Drug: Placebo Capsules

Outcome Measures

Primary Outcome Measures

Safety and tolerability of TD-1211 [14 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)