Parecoxib in Renal Colic

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139646
First received: August 29, 2005
Last updated: May 2, 2008
Last verified: May 2008

August 29, 2005
May 2, 2008
April 2002
Not Provided
Evaluation of efficacy through: time to onset of pain relief and time to remedication.
Same as current
Complete list of historical versions of study NCT00139646 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Parecoxib in Renal Colic
A Multicenter Single-Blind, Single Dose Efficacy and Safety Pilot Study Comparing Intramuscular Parecoxib and Diclofenac in Renal Colic

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Colic
  • Drug: Parecoxib
  • Drug: Diclofenac
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
April 2004
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00139646
124-IFL-0505-005, A3481007
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP