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Completed

NCT Number: NCT00448110

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

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

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alabama Clinical Therapeutics, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Diclofenac (DIC075V)

Drug

Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels

Intravenous Ketorolac

Drug

Intravenous Ketorolac

Placebo

Drug

placebo

Primary outcomes

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

    Time frame: 0-48 hours

Secondary outcomes

  1. SPID over the 0-24 hour interval

    Time frame: 0-24 hours

  2. Other measures of pain relief

    Time frame: Multiple

Sponsors and collaborators

Lead sponsor

Javelin Pharmaceuticals

Industry

Registry information

Official study title

Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 15, 2007
Registry last updated
May 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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