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NCT01619839 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
A Phase 2 study, sponsored by Nektar Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 296
- Enrollment target
NCT01619839: Completed Phase 2 study, sponsored by Nektar Therapeutics.
NCT01619839 is a Phase 2 study that has completed, run by Nektar Therapeutics. The registered enrollment target is 296 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01619839, a Phase 2 study, has completed, sponsored by Nektar Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 296 participants
- Enrollment target
Study Summary
NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe chronic pain - active as a mu agonist, but with inherent molecular properties designed to provide a unique clinical profile, including most notably, reduced CNS side effects and an attenuated attractiveness as a target of abuse.
Primary Outcome
The first phase of this trial involved an open-label titration period where patients were given NKTR-181 at increasing doses up to a maximum of 400 mg twice daily until adequate pain control was achieved. Patients achieving adequate pain control were then progressed to the second phase of the trial where patients were randomized in a 1:1 ratio to receive either placebo or their tolerable dose level of NKTR-181. All efficacy data for NKTR-181 patients was combined into one group regardless of to
Interventions
- DRUG Placebo
- DRUG NKTR-181
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT01619839 record still lists
NCT01619839 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01619839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01619839 about?
NCT01619839 is a clinical study titled "A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain". NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe chronic pain - active as a mu agonist, but with inherent molecular properties designed to provide a unique clinical profile, including most notably, reduced CNS side effects and an attenuated attractiveness ...
What is the current status of trial NCT01619839?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 296 participants. The study started on 2012-06. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01619839?
The interventions under investigation include: Placebo (DRUG), NKTR-181 (DRUG).
Who is sponsoring clinical trial NCT01619839?
This trial is sponsored by Nektar Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01619839's enrollment target sits among peer trials
296 189th of 2000 higher than 1,812 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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