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NCT01309841 · ClinicalTrials.gov registry record · Phase 3
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 652
- Enrollment target
NCT01309841: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01309841 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 652 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01309841, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 652 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).
Primary Outcome
Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.
Interventions
- DRUG Placebo
- DRUG NKTR-118
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 652 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT01309841 record still lists
NCT01309841 is an interventional study that assigns participants to a tested intervention. The registered 652 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01309841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01309841 about?
NCT01309841 is a clinical study titled "Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation". The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).
What is the current status of trial NCT01309841?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 652 participants. The study started on 2011-03. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01309841?
The interventions under investigation include: Placebo (DRUG), NKTR-118 (DRUG).
Who is sponsoring clinical trial NCT01309841?
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 NCT01309841's enrollment target sits among peer trials
652 571st of 2000 higher than 1,429 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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