CompletedPhase 2

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

United States69 participantsStarted 2011-05

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211

Timeframe: Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks

Trial details

NCT IDNCT01333540

SponsorTheravance Biopharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-05

View on ClinicalTrials.gov More Opioid-induced Constipation (OIC) trials