Phase 4
N=340
Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00553605 ↗Enrolled (actual)
340
Serious AEs
5.0%
Results posted
Jan 2013
Primary outcome: Primary: Mean Pain Intensity Difference at 30 Minutes (mPID30min) — 34.147; 35.266 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketoprofen 100mg (Drug); Parecoxib 40mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pain Intensity Difference at 30 Minutes (mPID30min) |
34.147; 35.266 | — |
| SECONDARY Mean Pain Intensity Difference at 120 Min (mPID120min) |
51.608; 51.697 | 0.972 |
| SECONDARY Time-specific Pain Intensity (PI) VAS Score |
77.14; 76.99; 50.42; 50.95; 34.13; 33.65 | — |
| SECONDARY Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 |
26.72; 26.04; 42.89; 43.22; 54.37; 53.55 | 0.768 |
| SECONDARY Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min) |
362.42; 352.29 | 0.451 |
| SECONDARY Number of Participants With Pain Relief (PR) |
10; 9; 21; 19; 35; 44 | 0.3982 |
| SECONDARY Number of Participants With Response in Pain Intensity |
132; 124 | 0.9785 |
| SECONDARY Patient's Global Evaluation of Study Medication |
12; 10; 21; 17; 76; 66 | 0.2482 |
| SECONDARY Physician's Global Evaluation of Study Medication |
11; 11; 22; 23; 69; 63 | 0.9783 |
| SECONDARY Number of Participants With Use of Rescue Medication (RM) |
26; 25 | 0.9645 |
Summary
This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen.
Eligibility Criteria
Inclusion Criteria
- Patient male or female with a confirmed diagnosis of acute renal colic with moderate to severe pain according to the VAS and Categoric pain scales
Exclusion Criteria
- The patient has significant renal or hepatic conditions other than uncomplicated kidney stones.
- The patient has a history of clinically significant hypersensitivity to any NSAIDs, cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross sensitivity to the medications used in this study.
Data sourced from ClinicalTrials.gov (NCT00553605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.