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NCT01384292 · ClinicalTrials.gov registry record · Phase 3
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
A Phase 3 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 3
- Development phase
- 14
- Enrollment target
NCT01384292: Clinical Trial Phase 3 study, sponsored by AstraZeneca.
NCT01384292 is a Phase 3 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 14 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01384292, a Phase 3 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 14 participants
- Enrollment target
Study 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).
Primary Outcome
Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.
Interventions
- DRUG Placebo
- DRUG NKTR-118
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
Why NCT01384292 stopped before completion
NCT01384292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01384292 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01384292 about?
NCT01384292 is a clinical study titled "Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain". 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 t...
What is the current status of trial NCT01384292?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 14 participants. The study started on 2011-06. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01384292?
The interventions under investigation include: Placebo (DRUG), NKTR-118 (DRUG).
Who is sponsoring clinical trial NCT01384292?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01384292's enrollment target sits among peer trials
14 1983rd of 2000 higher than 17 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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