Colic
Conditions
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.
Interventions
DRUGParecoxib
DRUGDiclofenac
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of efficacy through: time to onset of pain relief and time to remedication. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed