NCT00553605

Brief Summary

This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Jun 2007

Typical duration for phase_4 pain

Geographic Reach
6 countries

17 active sites

Status
completed

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

June 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

January 28, 2013

Completed
Last Updated

January 28, 2013

Status Verified

December 1, 2012

Enrollment Period

2 years

First QC Date

November 2, 2007

Results QC Date

December 20, 2012

Last Update Submit

December 20, 2012

Conditions

Pain

Keywords

Renal Colic Pain Urinary Tract Colic

Outcome Measures

Primary Outcomes (1)

  • Mean Pain Intensity Difference at 30 Minutes (mPID30min)

    mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.

    Minute 30

Secondary Outcomes (9)

  • Mean Pain Intensity Difference at 120 Min (mPID120min)

    Minute 120

  • Time-specific Pain Intensity (PI) VAS Score

    Baseline, Minute 15, 30, 45, 60, 90, 120

  • Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120

    Baseline, Minute 15, 30, 45, 60, 90, 120

  • Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)

    Baseline through Minute 120

  • Number of Participants With Pain Relief (PR)

    Minute 30, 120

  • +4 more secondary outcomes

Study Arms (2)

I

ACTIVE COMPARATOR

Ketoprofen plus placebo parecoxib

Drug: Ketoprofen 100mg

II

ACTIVE COMPARATOR

Parecoxib plus placebo ketoprofen

Drug: Parecoxib 40mg

Interventions

Ketoprofen 100mgDRUG

Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection

I
Parecoxib 40mgDRUG

Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period

II

Eligibility Criteria

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

You may qualify if:

  • Patient male or female with a confirmed diagnosis of acute renal colic with moderate to severe pain according to the VAS and Categoric pain scales

You may not qualify if:

  • The patient has significant renal or hepatic conditions other than uncomplicated kidney stones.
  • The patient has a history of clinically significant hypersensitivity to any NSAIDs, cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross sensitivity to the medications used in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, CEP 20551-030, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Pfizer Investigational Site

Ribeirão Preto, São Paulo, 14015-130, Brazil

Location

Pfizer Investigational Site

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Pfizer Investigational Site

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04262-000, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04321-120, Brazil

Location

Pfizer Investigational Site

Vila Mariana - São Paulo, São Paulo, 04122-000, Brazil

Location

Pfizer Investigational Site

Providencia, Santiago, RM, 7500921, Chile

Location

Pfizer Investigational Site

Alajuela, Alajuela Province, Costa Rica

Location

Pfizer Investigational Site

Desamparados, Provincia de San José, Costa Rica

Location

Pfizer Investigational Site

San José, Provincia de San José, Costa Rica

Location

Pfizer Investigational Site

Quito, Pichincha, Ecuador

Location

Pfizer Investigational Site

San Pedro Sula, San Pedro Sula, Honduras

Location

Pfizer Investigational Site

Lima, Lima Province, L 31, Peru

Location

Pfizer Investigational Site

Lima, Lima Province, L27, Peru

Location

Related Links

MeSH Terms

Conditions

Pain

Interventions

Ketoprofenparecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Limitations and Caveats

PR at all time points, proportion of participants with \>= 1 grade improvement in PR 30 min were replaced by PR at 30 and 120 min; number of participants with response in PI included; time to RM reported as number, due to change in planned analysis.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 5, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 28, 2013

Results First Posted

January 28, 2013

Record last verified: 2012-12

Locations

PE(2)BR(9)EC(1)CL(1)HO(1)CO(3)