Clinical trial NCT00726388: An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: safety
diclofenac
pain, postoperative
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-31
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
measure: Number of Participants Who Took at Least 1 Concomitant Medication
timeFrame: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
measure: Number of Participants With Abnormal Urinalysis Findings
timeFrame: Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5)
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline
timeFrame: Baseline (Day 1, immediately before dosing)
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination
timeFrame: Study discharge/early termination (maximum up to Day 5)
measure: Change From Baseline in Blood Pressure at Study Discharge/Early Termination
timeFrame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
measure: Change From Baseline in Blood Pressure at Clinic Follow-up Visit
timeFrame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
measure: Change From Baseline in Respiratory Rate at Study Discharge/Early Termination
timeFrame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
measure: Change From Baseline in Respiratory Rate at Clinic Follow-up Visit
timeFrame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
measure: Change From Baseline in Heart Rate at Study Discharge/Early Termination
timeFrame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
measure: Change From Baseline in Heart Rate at Clinic Follow-up Visit
timeFrame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
measure: Number of Participants With Wound Assessment at Study Discharge/Early Termination
timeFrame: Study discharge/early termination (maximum up to Day 5)
measure: Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline
timeFrame: Baseline (Day 1, immediately before dosing)
measure: Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination
timeFrame: Study discharge/early termination (maximum up to Day 5)
measure: Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening
timeFrame: Screening (0 to 21 days prior to surgery)
measure: Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit
timeFrame: Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: West Alabama Research, LLC
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Florence
country: United States
facility: Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Group
state: Alabama
city: Montgomery
country: United States
facility: Drug Research and Analysis Corp.
state: Alabama
city: Montgomery
country: United States
facility: Jackson Hospital
state: Alabama
city: Sheffield
country: United States
facility: Helen Keller Memorial Hospital
state: Alabama
city: Peoria
country: United States
facility: Pivotal Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Little Rock
country: United States
facility: Teton Research, LLC
state: Arkansas
city: Bakersfield
country: United States
facility: Vertex
state: California
city: Glendale
country: United States
facility: Lotus Clinical Research
state: California
city: Laguna Hills
country: United States
facility: Physicians Clinical Research
state: California
city: Los Angeles
country: United States
facility: National Institute of Clinical Research
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Vista
country: United States
facility: North Coast Women's Care
state: California
city: Aurora
country: United States
facility: American Clinical Research
state: Colorado
city: Englewood
country: United States
facility: Colorado Orthopedic Consultants
state: Colorado
city: Steamboat Springs
country: United States
facility: American Clinical Research Services
state: Colorado
city: Hartford
country: United States
facility: Orthopedic Associates of Hartford
state: Connecticut
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research, Inc.
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants
state: Florida
city: Tampa
country: United States
facility: Florida Orthopedic Institute
state: Florida
city: Decatur
country: United States
facility: Soapstone Center for Clinical Research
state: Georgia
city: Mooresville
country: United States
facility: JRSI Foundation The center for Hip and Knee Surgery
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Department of Anesthesiology
state: Kansas
city: Merriam
country: United States
facility: Validity Research
state: Kansas
city: New Orleans
country: United States
facility: Tulane Univ. Medical Center
state: Louisiana
city: Great Falls
country: United States
facility: Great Falls Clinic, LLP
state: Montana
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Altoona
country: United States
facility: University of Orthopedics Center
state: Pennsylvania
city: Johnstown
country: United States
facility: Ilumina Clinical Associates
state: Pennsylvania
city: Johnstown
country: United States
facility: Ilumina Clinical Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian-Shadyshide Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC-St. Margaret's Hospital
state: Pennsylvania
city: Somerset
country: United States
facility: Somerset Hospital
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Hendersonville
country: United States
facility: Comprehensive Pain Specialists, PLLC
state: Tennessee
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Interventional Pain Management
state: Texas
city: Temple
country: United States
facility: Scott & White Clinic / Texas A&M Health Science Center
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
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.