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

Glycyx Therapeutics69 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Opioid-induced Constipation (OIC)

Interventions

TD-1211DRUG

Escalating doses

PlaceboDRUG

Placebo once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Research Unit

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels

Time frame: Continuous assessments for up to six weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.