Back to resultsParecoxib in Renal Colic
Primary Purpose
Colic
Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Parecoxib
Diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Colic
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00139646
Brief Title
Parecoxib in Renal Colic
Official Title
A Multicenter Single-Blind, Single Dose Efficacy and Safety Pilot Study Comparing Intramuscular Parecoxib and Diclofenac in Renal Colic
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
See Detailed Description
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Parecoxib
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Primary Outcome Measure Information:
Title
Evaluation of efficacy through: time to onset of pain relief and time to remedication.
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Alessandria
ZIP/Postal Code
15100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=124-IFL-0505-005&StudyName=Parecoxib+in+renal+colic
Description
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Parecoxib in Renal Colic
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