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NCT01395524 · ClinicalTrials.gov registry record · Phase 3
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 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
- 302
- Enrollment target
NCT01395524: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01395524 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 302 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01395524, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 302 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 over a 6-month period.
Primary Outcome
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Interventions
- DRUG Placebo
- DRUG NKTR-118
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01395524 record still lists
NCT01395524 is an interventional study that assigns participants to a tested intervention. The registered 302 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 (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01395524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01395524 about?
NCT01395524 is a clinical study titled "A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 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 over a 6-month period.
What is the current status of trial NCT01395524?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 2011-07. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01395524?
The interventions under investigation include: Placebo (DRUG), NKTR-118 (DRUG).
Who is sponsoring clinical trial NCT01395524?
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 NCT01395524's enrollment target sits among peer trials
302 1119th of 2000 higher than 880 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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