Clinical trial NCT00448110: Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.
timeFrame: 0-48 hours
Secondary outcomes:
measure: SPID over the 0-24 hour interval
timeFrame: 0-24 hours
measure: Other measures of pain relief
timeFrame: Multiple
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Florence
country: United States
facility: Eliza Coffee Memorial Hospital
state: Alabama
city: Montgomery
country: United States
facility: Drug Research and Analysis Corp.
state: Alabama
city: Sheffield
country: United States
facility: Helen Keller Hospital
state: Alabama
city: Little Rock
country: United States
facility: Teton Research / Parkview Surgical
state: Arkansas
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Bismarck
country: United States
facility: Clinical Research Services
state: North Dakota
city: Austin
country: United States
facility: Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Healthcare System - Memorial City Hospital
state: Texas
city: San Marcos
country: United States
facility: Clinical Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Javelin Pharmaceuticals
name: Javelin Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.
citation: Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10.