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

Javelin Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Intravenous Diclofenac (DIC075V); Drug: placebo; Drug: Intravenous Ketorolac

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448110

DFC-004

Details and patient eligibility

About

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

Full description

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.

Enrollment: 331 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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331 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

intravenous diclofenac dosage level 1

Treatment:

Drug: Intravenous Diclofenac (DIC075V)

B

Experimental group

Description:

intravenous diclofenac dosage level 2

Treatment:

Drug: Intravenous Diclofenac (DIC075V)

C

Active Comparator group

Description:

intravenous ketorolac

Treatment:

Drug: Intravenous Ketorolac

D

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo