A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-06-30

Brief Summary

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A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation.

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Detailed Description

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Conditions

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Opioid-induced Constipation (OIC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

Escalating Doses of TD-1211

Group Type EXPERIMENTAL

TD-1211

Intervention Type DRUG

Escalating doses

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily

Interventions

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TD-1211

Escalating doses

Intervention Type DRUG

Placebo

Placebo once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females between 18 and 65 years of age, inclusive
* Subjects with documented OIC on stable opioid regimen
* Willingness to stop all laxatives throughout run-in and treatment period

Exclusion Criteria

* Any clinically significant findings in subjects with OIC
* Have participated in another clinical trial of an investigational drug 30 days prior to screening
* History of chronic constipation prior to opioid therapy in OIC subjects
* Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No