Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
NCT01336205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 844
Last updated 2014-10-20
Summary
The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
Conditions
- Opioid-Induced Constipation (OIC)
Interventions
- DRUG
-
NKTR-118
25 mg oral tablet once daily
- DRUG
-
Usual care
As prescribed by the investigator
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Mark Sostek · AstraZeneca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 84 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- United States
Study Locations
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