Opioid Induced Constipation
Conditions
Keywords
Opioid induced constipation, OIC, Constipation, Opioid side effects, morphine induced constipation
Brief summary
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
Interventions
DRUGTD-1211
Capsules
DRUGPlacebo
Capsules
Sponsors
Glycyx Therapeutics
Theravance Biopharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* stable dose of opioids for at least 12 weeks before screening visit * less than or equal to 5 spontaneous bowel movements for a 2 week period and experiencing at least one other symptom of constipation * willing to stop laxatives and other bowel treatments; rescue laxative allowed
Exclusion criteria
* Clinically significant condition or illness (other than the condition for which the pain medication was prescribed) * Have participated in another clinical trial of an investigational drug 30 days prior to screening * History of cancer treatment except adequately treated localized skin cancer within 5 years of screening * History of chronic constipation prior to opioid therapy * Females who are pregnant or breast feeding * Have any condition that may affect drug absorption (e.g. previous GI surgery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of TD-1211 | 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM) | Weekly assessments throughout Treatment Period | Change from baseline in the weekly SBM and CSBM frequency |
Countries
United States
Contacts
STUDY_DIRECTORMedical Monitor
Theravance Biopharma
Outcome results
None listed