Overview

This trial is active, not recruiting.

Condition pain, postoperative
Treatment dic075v (intravenous diclofenac sodium)
Phase phase 3
Sponsor Javelin Pharmaceuticals
Start date September 2008
End date April 2009
Trial size 850 participants
Trial identifier NCT00726388, DFC-010

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days
dic075v (intravenous diclofenac sodium)
multiple doses up to 5 days

Primary Outcomes

Measure
Adverse Events
time frame: 30 days

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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,

Additional Information

Official title An Open-Label, Multiple-Dose, Multiple-Day, Non-Randomized, Single-Arm Safety Study Of Repeat-Doses Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Javelin Pharmaceuticals.