A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
Status and phase
Completed
Phase 2
Conditions
Opioid Induced Constipation
Treatments
Drug: TD-1211
Drug: Placebo
Details and patient eligibility
About
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
Enrollment
95 patients
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
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)
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Sequential Assignment
Masking
Single Blind
95 participants in 6 patient groups
Cohort 1
Experimental group
Description:
5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days
Treatment:
Drug: TD-1211
Cohort 2
Experimental group
Description:
5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days
Treatment:
Drug: TD-1211
Cohort 3
Experimental group
Description:
5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days
Treatment:
Drug: TD-1211
Cohort 4
Experimental group
Description:
5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days
Treatment:
Drug: TD-1211
Cohort 5
Experimental group
Description:
2 mg TD-1211 once daily for 14 days
Treatment:
Drug: TD-1211
Drug: Placebo
Cohort 6
Experimental group
Description:
2.5 mg TD-1211 every 6 hours for 14 days
Treatment:
Drug: TD-1211
Drug: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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