NCT00139646

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
Last Updated

May 6, 2008

Status Verified

May 1, 2008

First QC Date

August 29, 2005

Last Update Submit

May 2, 2008

Conditions

Colic

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

ParecoxibDRUG
DiclofenacDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of renal colic;
  • baseline pain \> 50 mm on VAS;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Alessandria, 15100, Italy

Location

Pfizer Investigational Site

Grosseto, 58100, Italy

Location

Pfizer Investigational Site

Modena, 41100, Italy

Location

Pfizer Investigational Site

Pavia, 27100, Italy

Location

Pfizer Investigational Site

Siena, 53100, Italy

Location

Related Links

MeSH Terms

Conditions

Colic

Interventions

parecoxibDiclofenac

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

April 1, 2002

Study Completion

April 1, 2004

Last Updated

May 6, 2008

Record last verified: 2008-05

Locations

IT(5)