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

NCT00661635 | Completed Phase 3

• 2 other identifiers: VALA-0513-145A3471085
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 65

Brief Summary

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.

Conditions

Laparoscopic Cholecystectomy; Pain

Keywords

Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain

Outcome Measures

Primary Outcomes (2)

• Patient's Global Evaluation of Study Medication

  Day 2 and Day 3

• Summed Pain Intensity (categorical) through 24 hours (SPI 24)

  Day 2 and Day 3

Secondary Outcomes (11)

• Time-specific PI (VAS)

  Days 2 to 5

• Patient's Global Evaluation of Study Medication

  Day 4 and Day 5

• Time to first dose of rescue medication

  Days 2 to 5

• Percent of patients who took rescue medication on each study day

  Days 2 to 5

• Amount of rescue medication taken

  Days 2 to 5

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Drug: valdecoxib

Arm 2

ACTIVE COMPARATOR

Drug: valdecoxib

Arm 3

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

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

Arm 3

valdecoxib DRUG

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 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (65)

Pfizer Investigational Site

Birmingham, Alabama, 35213, United States

Location

Pfizer Investigational Site

Daphne, Alabama, 36526, United States

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Fairhope, Alabama, 36532, United States

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Mobile, Alabama, 36617, United States

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Pfizer Investigational Site

Mobile, Alabama, 36693, United States

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Sheffield, Alabama, 35660, United States

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Glendale, Arizona, 85306, United States

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Glendale, Arizona, 85308, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85020, United States

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Phoenix, Arizona, 85023, United States

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Phoenix, Arizona, 85027, United States

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Tucson, Arizona, 85710, United States

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Tucson, Arizona, 85711, United States

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Tucson, Arizona, 85712, United States

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Anaheim, California, 92801, United States

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Bakersfield, California, 93309, United States

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Bakersfield, California, 93311, United States

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Los Angeles, California, 90017, United States

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Los Angeles, California, 90057, United States

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Pasadena, California, 91109, United States

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Sacramento, California, 95817, United States

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San Jose, California, 95124, United States

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Woodland, California, 95695, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33176, United States

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Pensacola, Florida, 32504, United States

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Blue Ridge, Georgia, 30513, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60611, United States

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Maywood, Illinois, 60153, United States

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Iowa City, Iowa, 52242, United States

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Shreveport, Louisiana, 71105, United States

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Baltimore, Maryland, 21229, United States

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Germantown, Maryland, 20874, United States

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Rockville, Maryland, 20850, United States

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Silver Spring, Maryland, 20902, United States

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Jackson, Mississippi, 39202, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27103-3315, United States

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Winston-Salem, North Carolina, 27103, United States

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Oklahoma City, Oklahoma, 73104, United States

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Allentown, Pennsylvania, 18103, United States

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Philadelphia, Pennsylvania, 19107-4998, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Charleston, South Carolina, 29406, United States

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Columbia, South Carolina, 29203, United States

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Columbia, South Carolina, 29209, United States

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Mt. Pleasant, South Carolina, 29464, United States

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North Charleston, South Carolina, 29406, United States

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Summerville, South Carolina, 29485, United States

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Bristol, Tennessee, 37620, United States

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Kingsport, Tennessee, 37660, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77055, United States

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San Antonio, Texas, 78224, United States

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Pfizer Investigational Site

Universal City, Texas, 78148, United States

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Sandy City, Utah, 84070, United States

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Pfizer Investigational Site

Sandy City, Utah, 84094, United States

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Pfizer Investigational Site

West Jordan, Utah, 84088, United States

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Norfolk, Virginia, 23517, United States

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Pfizer Investigational Site

Suffolk, Virginia, 23434, United States

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Pfizer Investigational Site

Renton, Washington, 98055, United States

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Pfizer Investigational Site

Renton, Washington, 98058-5010, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain; Acute Pain

Interventions

valdecoxib

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 18, 2008
• Study Start: November 1, 2002
• Study Completion: July 1, 2003
• Last Updated: April 23, 2008

Record last verified: 2008-03

Locations

US (65)