Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic (NAP)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00553605
First received: November 2, 2007
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Ketoprofen 100mg Drug: Parecoxib 40mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Double-Dummy, Randomized, Multicenter Study Comparing The Analgesic Efficacy And Safety Of Parecoxib 40mg I.V. To Ketoprofen 100mg I.V. In Renal Colic |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Mean Pain Intensity Difference at 30 Minutes (mPID30min) [ Time Frame: Minute 30 ] [ Designated as safety issue: No ]mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.
Secondary Outcome Measures:
- Mean Pain Intensity Difference at 120 Min (mPID120min) [ Time Frame: Minute 120 ] [ Designated as safety issue: No ]mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 120 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 120 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.
- Time-specific Pain Intensity (PI) VAS Score [ Time Frame: Baseline, Minute 15, 30, 45, 60, 90, 120 ] [ Designated as safety issue: No ]PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain.
- Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 [ Time Frame: Baseline, Minute 15, 30, 45, 60, 90, 120 ] [ Designated as safety issue: No ]PID score was obtained by subtracting the PI-VAS at each time point from baseline PI score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. PID score ranged from -100 to 100. Positive score= improved response in pain.
- Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min) [ Time Frame: Baseline through Minute 120 ] [ Designated as safety issue: No ]TOTPAR: time-weighted sum of Pain Relief (PR) over 120 min. TOTPAR score range was 0 (worst) to 480 (best). PR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
- Number of Participants With Pain Relief (PR) [ Time Frame: Minute 30, 120 ] [ Designated as safety issue: No ]PR was assessed on a 5-point categorical pain relief rating scale wherein 0= None, 1= a little, 2= Some, 3= a lot and 4= Complete relief.
- Number of Participants With Response in Pain Intensity [ Time Frame: Minute 30 ] [ Designated as safety issue: No ]PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. Responders were those who had a decreased in VAS of at least 20 mm.
- Patient's Global Evaluation of Study Medication [ Time Frame: Minute 30, 120 ] [ Designated as safety issue: No ]Participants' response to the question "How would you rate the study medication you received for pain?" on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.
- Physician's Global Evaluation of Study Medication [ Time Frame: Minute 30, 120 ] [ Designated as safety issue: No ]Physicians' response to the question "How would you rate the study medication the patient received for pain?" on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.
- Number of Participants With Use of Rescue Medication (RM) [ Time Frame: Up to Minute 120 ] [ Designated as safety issue: No ]Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.
| Enrollment: | 340 |
| Study Start Date: | June 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: I
Ketoprofen plus placebo parecoxib
|
Drug: Ketoprofen 100mg
Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection
|
|
Active Comparator: II
Parecoxib plus placebo ketoprofen
|
Drug: Parecoxib 40mg
Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553605
Locations
| Brazil | |
| Pfizer Investigational Site | |
| Rio de Janeiro, RJ, Brazil, CEP 20551-030 | |
| Pfizer Investigational Site | |
| Porto Alegre, RS, Brazil, 90610-000 | |
| Pfizer Investigational Site | |
| Porto Alegre, RS, Brazil, 90035-003 | |
| Pfizer Investigational Site | |
| Ribeirao Preto, SP, Brazil, 14015-130 | |
| Pfizer Investigational Site | |
| Ribeirao Preto, SP, Brazil, 14048-900 | |
| Pfizer Investigational Site | |
| Sao Bernardo do Campo, SP, Brazil, 09715-090 | |
| Pfizer Investigational Site | |
| Sao Paulo, SP, Brazil, 04262-000 | |
| Pfizer Investigational Site | |
| São Paulo, SP, Brazil, 04321-120 | |
| Pfizer Investigational Site | |
| Vila Mariana - São Paulo, SP, Brazil, 04122-000 | |
| Chile | |
| Pfizer Investigational Site | |
| Providencia, Santiago, RM, Chile, 7500921 | |
| Costa Rica | |
| Pfizer Investigational Site | |
| Desamparados, San Jose, Costa Rica | |
| Pfizer Investigational Site | |
| San José, San Jose, Costa Rica | |
| Pfizer Investigational Site | |
| Alajuela, Costa Rica | |
| Ecuador | |
| Pfizer Investigational Site | |
| Quito, Pichincha, Ecuador | |
| Honduras | |
| Pfizer Investigational Site | |
| San Pedro Sula, Honduras | |
| Peru | |
| Pfizer Investigational Site | |
| Lima, Peru, L27 | |
| Pfizer Investigational Site | |
| Lima, Peru, L 31 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00553605 History of Changes |
| Other Study ID Numbers: | A3481065 |
| Study First Received: | November 2, 2007 |
| Results First Received: | December 20, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | Ecuador: Public Health Ministry |
Keywords provided by Pfizer:
|
Renal Colic Pain Urinary Tract Colic |
Additional relevant MeSH terms:
|
Renal Colic Colic Abdominal Pain Pain Signs and Symptoms Signs and Symptoms, Digestive Ketoprofen Parecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013