Trials / Terminated
TerminatedNCT01384292
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients With Cancer-Related Pain
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR). The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week extension with active treatment (part B).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NKTR-118 | 12.5 mg oral tablet once daily |
| DRUG | NKTR-118 | 25 mg oral tablet once daily |
| DRUG | Placebo | Oral treatment |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2012-09-01
- Completion
- 2012-09-01
- First posted
- 2011-06-29
- Last updated
- 2015-06-01
- Results posted
- 2015-06-01
Locations
140 sites across 14 countries: United States, Australia, Belgium, Bulgaria, Croatia, Czechia, Germany, Poland, Puerto Rico, Romania, Slovakia, South Africa, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01384292. Inclusion in this directory is not an endorsement.