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NCT02290821 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 215
- Enrollment target
NCT02290821: Completed Phase 3 study, sponsored by Novartis.
NCT02290821 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 215 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02290821, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 215 participants
- Enrollment target
Study Summary
This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.
Primary Outcome
The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the ITT population. SPID 24 derived from spontaneous Pain Intensity scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), t
Interventions
- DRUG placebo
- DRUG Placebos
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2014-12 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
What the finished NCT02290821 record still lists
NCT02290821 is an interventional study that assigns participants to a tested intervention. The registered 215 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 (72% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02290821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02290821 about?
NCT02290821 is a clinical study titled "Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries". This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.
What is the current status of trial NCT02290821?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 215 participants. The study started on 2014-12. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02290821?
The interventions under investigation include: placebo (DRUG), Placebos (DRUG).
Who is sponsoring clinical trial NCT02290821?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02290821's enrollment target sits among peer trials
215 1334th of 2000 higher than 666 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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