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Parecoxib in Renal Colic

This study has been terminated.
(See Detailed Description)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139646
First Posted: August 31, 2005
Last Update Posted: May 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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 Intervention Phase
Colic Drug: Parecoxib Drug: Diclofenac Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 50
Study Start Date: April 2002
Estimated Study Completion Date: April 2004
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00139646     History of Changes
Other Study ID Numbers: 124-IFL-0505-005
A3481007
First Submitted: August 29, 2005
First Posted: August 31, 2005
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