Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00553605

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Ketoprofen 100mg Drug: Parecoxib 40mg	Phase IV

Drug Information available for: Parecoxib Parecoxib sodium Ketoprofen Sodium chloride Chlorides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Double-Dummy, Randomized, Multicenter Study Comparing The Analgesic Efficacy And Safety Of Parecoxib 40mg I.V. To Ketoprofen 100mg I.V. In Renal Colic

Further study details as provided by Pfizer:

Primary Outcome Measures:

Mean pain intensity difference assessed by VAS between Time 0 and at 30 minutes after the administration of study medication. [ Time Frame: within 30 minutes after administration of study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with at least 1 grade improvement in pain relief (PR) 30 minutes after administration of study medication. [ Time Frame: 30 minutes after administration ] [ Designated as safety issue: No ]
Mean pain intensity difference at 120 minutes after the administration of study medication. [ Time Frame: 120 minutes after administration ] [ Designated as safety issue: No ]
Physician's global evaluation of study medication at 30 and 120 minutes after the administration of study medication. [ Time Frame: 30 and 120 minutes following administration ] [ Designated as safety issue: No ]
Sum of time interval weighted pain relief scores through the first 2 hours after the administration of study medication (TOTPAR2). [ Time Frame: within 120 minutes following administration ] [ Designated as safety issue: No ]
Time to rescue medication up to 120 minutes after the administration of study medication. [ Time Frame: from 30 to 120 minutes following administration ] [ Designated as safety issue: No ]
Incidence rate of adverse events and serious adverse events. [ Time Frame: 28 days following study medication administration ] [ Designated as safety issue: Yes ]
Time-specific pain intensity VAS scores at 30 and 120 minutes. [ Time Frame: at 30 and 120 minutes ] [ Designated as safety issue: No ]
Changes in vital signs. [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
Patient's global evaluation of study medication at 30 and 120 minutes after the administration of study medication. [ Time Frame: at 30 and 120 minutes following adminstration ] [ Designated as safety issue: No ]
Pain Relief at all post dose time points. [ Time Frame: at 15, 30, 45, 60, 90 and 120 minutes after study medication administration ] [ Designated as safety issue: No ]
Time-specific pain intensity difference (PID). [ Time Frame: from time 0 (study medication administration) until 2 hours after study medication administration ] [ Designated as safety issue: No ]

Estimated Enrollment:	336
Study Start Date:	June 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator Ketoprofen plus placebo parecoxib	Drug: Ketoprofen 100mg 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
II: Active Comparator Parecoxib plus placebo ketoprofen	Drug: Parecoxib 40mg 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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553605

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Brazil, RJ
Pfizer Investigational Site	Recruiting
Rio de Janeiro, RJ, Brazil, CEP 20551-030
Brazil, RS
Pfizer Investigational Site	Recruiting
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site	Recruiting
Porto Alegre, RS, Brazil, 90035-003
Pfizer Investigational Site	Not yet recruiting
Porto Alegre, RS, Brazil, 90470-340
Brazil, SP
Pfizer Investigational Site	Recruiting
Ribeirão Preto, SP, Brazil, 14048-900
Pfizer Investigational Site	Recruiting
São Bernardo do Campo, SP, Brazil, 09715-090
Pfizer Investigational Site	Active, not recruiting
Vila Mariana - São Paulo, SP, Brazil, 04122-000
Pfizer Investigational Site	Recruiting
Ribeirão Preto, SP, Brazil, 14015-130
Pfizer Investigational Site	Active, not recruiting
São Paulo, SP, Brazil, 04321-120
Pfizer Investigational Site	Recruiting
São Paulo, SP, Brazil, 04262-000
Chile, Santiago, RM
Pfizer Investigational Site	Recruiting
Providencia, Santiago, RM, Chile, 7500921
Costa Rica
Pfizer Investigational Site	Recruiting
Alajuela, Costa Rica
Costa Rica, San Jose
Pfizer Investigational Site	Recruiting
Desamparados, San Jose, Costa Rica
Pfizer Investigational Site	Completed
San José, San Jose, Costa Rica
Ecuador, Pichincha
Pfizer Investigational Site	Completed
Quito, Pichincha, Ecuador
Honduras, San Pedro Sula
Pfizer Investigational Site	Recruiting
San Pedro Sula, San Pedro Sula, Honduras
Peru
Pfizer Investigational Site	Active, not recruiting
Lima, Peru, L 31
Pfizer Investigational Site	Recruiting
Lima, Peru, L27

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3481065
Study First Received:	November 2, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00553605
Health Authority:	Ecuador: Public Health Ministry

Keywords provided by Pfizer:

Renal Colic Pain Urinary Tract Colic

Study placed in the following topic categories:

Ketoprofen
Parecoxib
Colic
Pain

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009