Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery

Javelin Pharmaceuticals331 enrolled

Overview

This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

331

Conditions

Pain, Postoperative

Interventions

Intravenous Diclofenac (DIC075V)DRUG

Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels

Intravenous KetorolacDRUG

Intravenous Ketorolac

placeboDRUG

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Scheduled within two weeks of the screening visit to undergo abdominal or pelvic surgery * Moderate to severe pain within 6 hours following completion of the required surgery. Exclusion Criteria: * Surgical procedure involves a subcostal incision. * Chronic disease or recent cardiovascular events. * Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study. Additional Inclusion/Exclusion Criteria May Apply

Locations (14)

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Eliza Coffee Memorial Hospital

Florence, Alabama, United States

Drug Research and Analysis Corp.

Outcomes

Primary Outcomes

Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.

Time frame: 0-48 hours

Secondary Outcomes

SPID over the 0-24 hour interval

Time frame: 0-24 hours

Other measures of pain relief

Time frame: Multiple

Data from ClinicalTrials.gov

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