Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery

NCT00507026 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: DFC-005C1211009
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 8

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (5)

• Sum of the Pain Intensity Differences (SPID) Over 24 Hours

  Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 24 hours ranges from -2400 to 2400. A higher value indicates a better pain reduction.

  Over 24 hours post first dose

• Sum of the Pain Intensity Differences (SPID) Over 48 Hours

  Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 48 hours ranges from -4800 to 4800. A higher value indicates a better pain reduction.

  Over 48 hours post first dose

• Sum of the Pain Intensity Differences (SPID) Over 72 Hours

  Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 72 hours ranges from -7200 to 7200. A higher value indicates a better pain reduction.

  Over 72 hours post first dose

• Sum of the Pain Intensity Differences (SPID) Over 96 Hours

  Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 96 hours ranges from -9600 to 9600. A higher value indicates a better pain reduction.

  Over 96 hours post first dose

• Sum of the Pain Intensity Differences (SPID) Over 120 Hours

  Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 120 hours ranges from -12000 to 12000. A higher value indicates a better pain reduction.

  Over 120 hours post first dose

Secondary Outcomes (10)

• Pain Intensity Differences (PID) Over Time

  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

• Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity

  Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose

• Total Pain Relief (TOTPAR)

  0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose

• Visual Analog Pain Relief Values Over the Time

  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

• Time From Administration of Study Drug to Administration of Rescue Medication

  Maximum up to 5 days

Study Arms (3)

A

EXPERIMENTAL

DIC075V (IV diclofenac)

Drug: IV Diclofenac

B

ACTIVE COMPARATOR

IV Ketorolac

Drug: IV ketorolac

C

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

IV Diclofenac DRUG

IV Diclofenac q6h

A

IV ketorolac DRUG

IV ketorolac q6h

B

Placebo DRUG

Placebo q6h

C

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Accurate Clinical Trials

San Clemente, California, 92672, United States

Location

East Coast Clincial Research

Ft. Pierce, Florida, 34950, United States

Location

Outcomes Research Institute

Louisville, Kentucky, 40202, United States

Location

American Institute of Healthcare and Fitness

Raleigh, North Carolina, 27615, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16081, United States

Location

SCIREX

Austin, Texas, 78705, United States

Location

Related Publications (1)

• 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.

  PMID: 29492863 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Diclofenac; Ketorolac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: July 25, 2007
• Primary Completion: October 14, 2008
• Study Completion: October 14, 2008
• Last Updated: October 29, 2021
• Results First Posted: October 29, 2021

Record last verified: 2021-09

Locations

US (8)