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NCT00945945 · ClinicalTrials.gov registry record · Phase 3
A Study of Duloxetine in Patients With Osteoarthritis Knee Pain
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 424
- Enrollment target
NCT00945945: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT00945945 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 424 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00945945, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 424 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces pain severity in patients with osteoarthritis (OA) knee pain compared with placebo.
Primary Outcome
A self-reported measure of the severity of pain based on the average pain over 24-hours. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). BOCF endpoint was defined as the baseline value for participants discontinued during acute phase, and defined as the last non-missing observation in the treatment phase for all other randomized participants. Due to the nature of a study drug labeling error which led to a treatment crossover (see Arms), data from protocol-define
Interventions
- DRUG Duloxetine (DLX)
- DRUG Placebo (PLA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 424 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
What the finished NCT00945945 record still lists
NCT00945945 is an interventional study that assigns participants to a tested intervention. The registered 424 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 (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Duloxetine (DLX) is the first listed.
NCT00945945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00945945 about?
NCT00945945 is a clinical study titled "A Study of Duloxetine in Patients With Osteoarthritis Knee Pain". The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces pain severity in patients with osteoarthritis (OA) knee pain compared with placebo.
What is the current status of trial NCT00945945?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 424 participants. The study started on 2009-07. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00945945?
The interventions under investigation include: Duloxetine (DLX) (DRUG), Placebo (PLA) (DRUG).
Who is sponsoring clinical trial NCT00945945?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00945945's enrollment target sits among peer trials
424 884th of 2000 higher than 1,116 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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