A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00661635

Purpose

To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.

Condition	Intervention	Phase
Laparoscopic Cholecystectomy Pain	Drug: placebo Drug: valdecoxib	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Laparoscopic Cholecystectomy Surgery

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Valdecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Patient's Global Evaluation of Study Medication [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]
Summed Pain Intensity (categorical) through 24 hours (SPI 24) [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time-specific PI (VAS) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Patient's Global Evaluation of Study Medication [ Time Frame: Day 4 and Day 5 ] [ Designated as safety issue: No ]
Time to first dose of rescue medication [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Percent of patients who took rescue medication on each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Amount of rescue medication taken [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Time between doses of study medication [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Worst PI (derived from the mBPI-SF) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Average PI (derived from the mBPI-SF) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
SPI 24 (categorical) [ Time Frame: Day 4 and Day 5 ] [ Designated as safety issue: No ]
Time-specific PI (categorical) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
SPI 24 (VAS) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]

Enrollment:	490
Study Start Date:	November 2002
Study Completion Date:	July 2003

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: valdecoxib valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.
Arm 2: Active Comparator	Drug: valdecoxib valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
Arm 3: Placebo Comparator	Drug: placebo valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm)
Patients were able to get their first dose of study medication within 8 hours after the end of surgery

Exclusion Criteria:

Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation
Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures
Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening
Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661635

Show 65 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	VALA-0513-145, A3471085
Study First Received:	March 31, 2008
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00661635 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Pfizer:

Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain

Study placed in the following topic categories:

Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Pain

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Valdecoxib

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
Valdecoxib
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009