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NCT03554772 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Tolerability, Safety, and Pharmacokinetic Study of DFN-15
A Phase 2 study, sponsored by Dr. Reddy's Laboratories Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT03554772: Completed Phase 2 study, sponsored by Dr. Reddy's Laboratories Limited.
NCT03554772 is a Phase 2 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03554772, a Phase 2 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
Efficacy, Tolerability, Safety and Pharmacokinetic Study of DFN-15 in Post-Surgical Dental Pain.
Primary Outcome
The primary endpoint is the Summed Pain Intensity Difference over the first 6 hours (SPID6) after dosing compared between DFN-15 and placebo. Pain intensity (P) will be measured at timepoints of 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5 and 6, hours after baseline ,using 11-point Pain Intensity Numerical Rating Scale (NPRS). Zero (0) equals no pain and Ten (10) equals worst pain imaginable. SPID6 is created by summing the time weighted pain intensity differences (PID) scores using the area
Interventions
- DRUG Placebo
- DRUG DFN-15 (Celecoxib Oral Solution) 62.5 mg
- DRUG DFN-15 (Celecoxib Oral Solution) 125 mg
- DRUG DFN-15 (Celecoxib Oral Solution) 250 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2018-08-20 |
| Phase | Phase 2 |
What the finished NCT03554772 record still lists
NCT03554772 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03554772 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03554772 about?
NCT03554772 is a clinical study titled "Efficacy, Tolerability, Safety, and Pharmacokinetic Study of DFN-15". Efficacy, Tolerability, Safety and Pharmacokinetic Study of DFN-15 in Post-Surgical Dental Pain.
What is the current status of trial NCT03554772?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2018-06-19. Estimated completion is 2018-08-20.
What interventions are being tested in trial NCT03554772?
The interventions under investigation include: Placebo (DRUG), DFN-15 (Celecoxib Oral Solution) 62.5 mg (DRUG), DFN-15 (Celecoxib Oral Solution) 125 mg (DRUG), DFN-15 (Celecoxib Oral Solution) 250 mg (DRUG).
Who is sponsoring clinical trial NCT03554772?
This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03554772's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 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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