Not Signed In -
Diclofenac |
Voltaren |
Clinical Trial: Parecoxib in Renal Colic
This study is no longer recruiting patients.
|
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 III |
MedlinePlus related topics: Infant and Newborn Care
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter Single-Blind, Single Dose Efficacy and Safety Pilot Study Comparing Intramuscular Parecoxib and Diclofenac in Renal Colic
Further Study Details:
Primary Outcomes: Evaluation of efficacy through: time to onset of pain relief and time to remedication.
Secondary Outcomes: 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
Expected Total Enrollment: 50
Secondary Outcomes: 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
Expected Total Enrollment: 50
Study start: April 2002
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
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
Location Information
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: 124-IFL-0505-005
Last Updated: August 30, 2005
Record first received: August 29, 2005
ClinicalTrials.gov Identifier: NCT00139646
Health Authority: Italy: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: August 30, 2005
Record first received: August 29, 2005
ClinicalTrials.gov Identifier: NCT00139646
Health Authority: Italy: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Diclofenac (Drug Digest)
- Voltaren (Drug Digest)
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