Opioid-induced Constipation (OIC)
Conditions
Keywords
constipation, opioid induced
Brief summary
A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation.
Interventions
DRUGTD-1211
Escalating doses
DRUGPlacebo
Placebo once daily
Sponsors
Glycyx Therapeutics
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211 | Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels | Continuous assessments for up to six weeks |
Countries
United States
Contacts
STUDY_DIRECTORMedical Monitor
Theravance Biopharma
Outcome results
None listed