Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic (NAP)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Ketoprofen 100mg; Drug: Parecoxib 40mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00553605

A3481065

Details and patient eligibility

About

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.

Enrollment: 340 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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340 participants in 2 patient groups

I

Active Comparator group

Description:

Ketoprofen plus placebo parecoxib

Treatment:

Drug: Ketoprofen 100mg

II

Active Comparator group

Description:

Parecoxib plus placebo ketoprofen

Treatment:

Drug: Parecoxib 40mg