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

Theravance Biopharma

Status and phase: Completed; Phase 2

Conditions: Opioid-induced Constipation (OIC)

Treatments: Drug: TD-1211; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01333540

0074

Details and patient eligibility

About

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

Enrollment: 69 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Escalating Doses of TD-1211

Treatment:

Drug: TD-1211

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo