Parecoxib in Renal Colic
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colic
Intervention: Parecoxib (Drug); Diclofenac (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
This is a phase III, multicenter, randomized, single blind study designed to evaluate the
efficacy and tolerability of a single dose of parecoxib compared with diclofenac in the
treatment of acute pain due to renal colic.
Clinical Details
Official title: A Multicenter Single-Blind, Single Dose Efficacy and Safety Pilot Study Comparing Intramuscular Parecoxib and Diclofenac in Renal Colic
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluation of efficacy through: time to onset of pain relief and time to remedication.
Secondary outcome: Evaluation of efficacy through: Pain Intensity (VAS), Pain Relief (PR) and several measurements of analgesia that will be derived from VAS and PR
Physician's Global Evaluation at 12 hours
Patient's Global Evaluation at 12 hours
Detailed description:
This study was prematurely discontinued May 3, 2004 due to slow recruitment. The decision to
terminate the trial was not based on any safety concerns.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- diagnosis of renal colic;
- baseline pain > 50 mm on VAS;
Exclusion Criteria:
- evidence of neoplasm or any other severe disease of any organ, including any
psychiatric illness;
- active GI disease (e. g. Crohn's disease or ulcerative colitis) or any evidence of
concomitant disease which may lead to early termination of the study
Locations and Contacts
Pfizer Investigational Site, Siena 53100, Italy
Pfizer Investigational Site, Alessandria 15100, Italy
Pfizer Investigational Site, Modena 41100, Italy
Pfizer Investigational Site, Grosseto 58100, Italy
Pfizer Investigational Site, Pavia 27100, Italy
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org posting:
Starting date: April 2002
Ending date: April 2004
Last updated: May 2, 2008
|
