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Trial record 1 of 1 for:    NCT00139646
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Parecoxib in Renal Colic

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ClinicalTrials.gov Identifier: NCT00139646
Recruitment Status : Terminated (See Detailed Description)
First Posted : August 31, 2005
Last Update Posted : May 6, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE August 31, 2005
Last Update Posted Date May 6, 2008
Study Start Date  ICMJE April 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
Evaluation of efficacy through: time to onset of pain relief and time to remedication.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00139646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parecoxib in Renal Colic
Official Title  ICMJE A Multicenter Single-Blind, Single Dose Efficacy and Safety Pilot Study Comparing Intramuscular Parecoxib and Diclofenac in Renal Colic
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Colic
Intervention  ICMJE
  • Drug: Parecoxib
  • Drug: Diclofenac
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: August 29, 2005)
50
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00139646
Other Study ID Numbers  ICMJE 124-IFL-0505-005
A3481007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2008

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