Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

March 31, 2008

Last Updated Date

May 22, 2008

Start Date ^ICMJE

October 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00683137 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Health Outcomes Post-Discharge Recovery Experience [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
adverse events [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
Time to first dose of rescue medication (rescue analgesic medication) [ 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 Pain Intensity (PI) (categorical) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
SPI 24 (Visual Analog Scale [VAS]) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
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 ]
Percent of patients who took rescue medication (rescue analgesic medication) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Worst Pain Intensity (derived from the Modified BPI-Short Form) [ 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 ]
Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Symptom Distress Questionnaire [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Average Pain Intensity (derived from the Modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Amount of rescue medication (rescue analgesic medication) taken [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

Official Title ^ICMJE

Clinical Protocol for 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 Bunionectomy Surgery

Brief Summary

The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pain
Hallux Valgus

Intervention ^ICMJE

Drug: valdecoxib
Drug: valdecoxib/placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

450

Completion Date

February 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
Patients with a baseline pain intensity (categorical) of moderate or severe

Exclusion Criteria:

Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00683137

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

VALA-0513-144, A3471084

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP