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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: IV Diclofenac; Drug: IV ketorolac; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00507026

C1211009 (Other Identifier)

DFC-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 277 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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277 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

DIC075V (IV diclofenac)

Treatment:

Drug: IV Diclofenac

B

Active Comparator group

Description:

IV Ketorolac

Treatment:

Drug: IV ketorolac

C

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo