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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00661635
First received: March 31, 2008
Last updated: April 21, 2008
Last verified: March 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Active Comparator: Arm 1 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.
Active Comparator: Arm 2 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.
Placebo Comparator: Arm 3 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:
No publications provided

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

Keywords provided by Pfizer:
Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain

Additional relevant MeSH terms:
Valdecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014