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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00661635
First received: March 31, 2008
Last updated: April 21, 2008
Last verified: March 2008
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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
Show 65 Study LocationsSponsors 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 May 19, 2013