Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 11:06 PM
Study NCT ID:
NCT00661635
Status:
COMPLETED
Last Update Posted:
2008-04-23
First Post:
2008-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C406224', 'term': 'valdecoxib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 490}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-21', 'studyFirstSubmitDate': '2008-03-31', 'studyFirstSubmitQcDate': '2008-04-15', 'lastUpdatePostDateStruct': {'date': '2008-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's Global Evaluation of Study Medication", 'timeFrame': 'Day 2 and Day 3'}, {'measure': 'Summed Pain Intensity (categorical) through 24 hours (SPI 24)', 'timeFrame': 'Day 2 and Day 3'}], 'secondaryOutcomes': [{'measure': 'Time-specific PI (VAS)', 'timeFrame': 'Days 2 to 5'}, {'measure': "Patient's Global Evaluation of Study Medication", 'timeFrame': 'Day 4 and Day 5'}, {'measure': 'Time to first dose of rescue medication', 'timeFrame': 'Days 2 to 5'}, {'measure': 'Percent of patients who took rescue medication on each study day', 'timeFrame': 'Days 2 to 5'}, {'measure': 'Amount of rescue medication taken', 'timeFrame': 'Days 2 to 5'}, {'measure': 'Time between doses of study medication', 'timeFrame': 'Days 2 to 5'}, {'measure': 'Worst PI (derived from the mBPI-SF)', 'timeFrame': 'Days 2 to 5'}, {'measure': 'Average PI (derived from the mBPI-SF)', 'timeFrame': 'Days 2 to 5'}, {'measure': 'SPI 24 (categorical)', 'timeFrame': 'Day 4 and Day 5'}, {'measure': 'Time-specific PI (categorical)', 'timeFrame': 'Days 2 to 5'}, {'measure': 'SPI 24 (VAS)', 'timeFrame': 'Days 2 to 5'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain'], 'conditions': ['Laparoscopic Cholecystectomy', 'Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=VALA-0513-145&StudyName=A%20Multiple-dose%2C%20Randomized%2C%20Double-blind%2C%20Placebo-controlled%20Study%20of%20the%20Analgesic%20Efficacy%20and%20Safety%20of%20Valdecoxib%20Compared%20to%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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)\n* Patients were able to get their first dose of study medication within 8 hours after the end of surgery\n\nExclusion Criteria:\n\n* 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\n* Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures\n* Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening\n* 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"}, 'identificationModule': {'nctId': 'NCT00661635', 'briefTitle': 'A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'VALA-0513-145'}, 'secondaryIdInfos': [{'id': 'A3471085'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'interventionNames': ['Drug: valdecoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: valdecoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Arm 3']}, {'name': 'valdecoxib', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Arm 2']}, {'name': 'valdecoxib', 'type': 'DRUG', 'description': '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 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