Adults 18 to 60, any sex, with Acute Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Summed Pain Intensity Difference Over the First Six HoursPrimary· 6 hours post dose
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 under the PID curve methodology. All SPID calculations will be performed using the standard trapezoi
Group
Value
95% CI
Placebo
-420.2
± 716.42
DFN-15 (Celecoxib Oral Solution) 62.5 mg
-1101.0
± 570.74
DFN-15 (Celecoxib Oral Solution) 125 mg
-1771.7
± 646.10
DFN-15 (Celecoxib Oral Solution) 250 mg
-1463.5
± 727.28
Adverse events — posted to ClinicalTrials.gov
Time frame: All AEs, whether volunteered, elicited, or noted on physical examination, and regardless of causality or seriousness, were assessed and recorded in the CRF beginning after administration of study drug through the final follow-up assessment (approximately 7 ± 3 days after the last study drug administration). Additionally, if the investigator became aware of the occurrence of an SAE within 30 days of the last visit, the SAE was reported..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT06779604 — Dexmedetomidine and Dexamethasone Added as Adjuvant Infraclavicular Brachial Plexus Block in Upper Limb Surgery
· recruiting
NCT07348419 — Quadro-Iliac vs Thoracolumbar Interfascial Plane Block for Analgesia After Single-Level Lumbar Disc Surgery
· NA
· recruiting
NCT07335159 — Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention
· NA
· recruiting
NCT07348523 — Comparison of the Postoperative Analgesic Efficacy of Classical and Modified Erector Spinae Plane Blocks After Lumbar Sp
· NA
· recruiting
NCT07336264 — Characterization of Acute Pain
· recruiting
Other Dr. Reddy's Laboratories Limited trials
Trials by the same sponsor.
NCT04529499 — Clinical Trial Evaluating the Efficacy and Safety of Favipiravir in Moderate to Severe COVID-19 Patients
· Phase 3
· terminated
NCT04268771 — A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products
· Phase 3
· completed
NCT03976102 — Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular
· Phase 3
· completed
NCT03421197 — A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)
· Phase 2
· completed
NCT03599193 — A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dr. Reddy's Laboratories Limited
Last refreshed: 22 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03554772.