An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: DIC075V (intravenous diclofenac sodium)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00726388

C1211011 (Other Identifier)

DFC-010

Details and patient eligibility

About

This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.

Full description

This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.

Enrollment: 1,050 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• abdominal ( non-laparoscopic abdominal surgeries) or orthopedic ( hip or knee joint replacement) surgery or other surgeries requiring multiple doses of parenterally administered NSAIDs over multiple days
• Expected stay > 48 hrs

Exclusion criteria

• bilirubin > 2.5 mg/dl
• prothrombin time is > 20% above the upper limit of normal
• serum creatinine is > 1.9 mg/dl at screening.
• known allergy or hypersensitivity to diclofenac, other NSAIDs,

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,050 participants in 1 patient group

A

Experimental group

Description:

IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days

Treatment:

Drug: DIC075V (intravenous diclofenac sodium)