Clinical trial NCT00507026: Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
Official title: Randomized, Double-Blind, Active-and Placebo-Controlled Study of the Analgesic Efficacy and Safety of Repeated Dosing of DIC075V Versus Parenteral Ketorolac and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.

Detailed description: The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.

Eligibility criteria: Inclusion Criteria:

* Scheduled within three weeks of the screening visit to undergo elective orthopedic surgery.
* Moderate to severe pain within 6 hours following completion of the required surgery.

Exclusion Criteria:

* Chronic pain conditions.
* Chronic disease or recent cardiovascular events.
* Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

Primary outcomes:
measure: Sum of the Pain Intensity Differences (SPID) Over 24 Hours
timeFrame: Over 24 hours post first dose
measure: Sum of the Pain Intensity Differences (SPID) Over 48 Hours
timeFrame: Over 48 hours post first dose
measure: Sum of the Pain Intensity Differences (SPID) Over 72 Hours
timeFrame: Over 72 hours post first dose
measure: Sum of the Pain Intensity Differences (SPID) Over 96 Hours
timeFrame: Over 96 hours post first dose
measure: Sum of the Pain Intensity Differences (SPID) Over 120 Hours
timeFrame: Over 120 hours post first dose
Secondary outcomes:
measure: Pain Intensity Differences (PID) Over Time
timeFrame: Baseline (0 hour), 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose
measure: Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity
timeFrame: Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose
measure: Total Pain Relief (TOTPAR)
timeFrame: 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose
measure: Visual Analog Pain Relief Values Over the Time
timeFrame: 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose
measure: Time From Administration of Study Drug to Administration of Rescue Medication
timeFrame: Maximum up to 5 days
measure: Cumulative Amount of Rescue Medication
timeFrame: 0-24, 0-48, 0-72, 0-96 and 0-120 hours
measure: Number of Participants According to Frequency of Use of Rescue Medication
timeFrame: 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose
measure: Participant Global Evaluation Over Time
timeFrame: 0-24, 0-48, 0-120 hours post-dose
measure: Time to Perceptible Relief
timeFrame: Within 6 hours of first dose on Day 1
measure: Time to Meaningful Relief
timeFrame: Within 6 hours of first dose on Day 1
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Helen Keller Hospital
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: San Clemente
country: United States
facility: Accurate Clinical Trials
state: California
city: Fort Pierce
country: United States
facility: East Coast Clincial Research
state: Florida
city: Louisville
country: United States
facility: Outcomes Research Institute
state: Kentucky
city: Raleigh
country: United States
facility: American Institute of Healthcare and Fitness
state: North Carolina
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Austin
country: United States
facility: SCIREX
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.