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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

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.

Condition or disease Intervention/treatment Phase
Colic Drug: Parecoxib Drug: Diclofenac Phase 3

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 : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Multicenter Single-Blind, Single Dose Efficacy and Safety Pilot Study Comparing Intramuscular Parecoxib and Diclofenac in Renal Colic
Study Start Date : April 2002
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Evaluation of efficacy through: time to onset of pain relief and time to remedication.

Secondary Outcome Measures :
  1. 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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139646


Locations
Italy
Pfizer Investigational Site
Alessandria, Italy, 15100
Pfizer Investigational Site
Grosseto, Italy, 58100
Pfizer Investigational Site
Modena, Italy, 41100
Pfizer Investigational Site
Pavia, Italy, 27100
Pfizer Investigational Site
Siena, Italy, 53100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00139646     History of Changes
Other Study ID Numbers: 124-IFL-0505-005
A3481007
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Colic
Renal Colic
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Diclofenac
Parecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors