An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
- Conditions
- Pain, Postoperative
- Interventions
- Drug: DIC075V (intravenous diclofenac sodium)
- Registration Number
- NCT00726388
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1050
- 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
- 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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A DIC075V (intravenous diclofenac sodium) IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days
- Primary Outcome Measures
Name Time Method Change From Baseline in Blood Pressure at Study Discharge/Early Termination Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days) Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in millimeter of mercury (mmHg) was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Change From Baseline in Heart Rate at Study Discharge/Early Termination Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days) Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Screening (0 to 21 days prior to surgery) Physical examination included the assessment of general appearance, skin; head, ears, eyes, nose, and throat (HEENT); neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Number of Participants With Abnormal Urinalysis Findings Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5) Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination Study discharge/early termination (maximum up to Day 5) 12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Number of Participants Who Took at Least 1 Concomitant Medication Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days) Concomitant medications were medications that were taken concurrently on or after first dose of study drug.
Change From Baseline in Blood Pressure at Clinic Follow-up Visit Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days) Change from baseline in SBP and DBP in mmHg was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Change From Baseline in Respiratory Rate at Study Discharge/Early Termination Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days) Respiratory rate was measured after the participant had taken rest for 5 minutes.
Number of Participants With Wound Assessment at Study Discharge/Early Termination Study discharge/early termination (maximum up to Day 5) Wound assessment had 6 questions, completed by investigator/sub-investigator. Question related to extent of healing; extent and degree of inflammation and extent of drainage had options: much better than expected, better than expected, normal, slower than expected, and much slower than expected. Question related to separation of surgical incision had options: no separation, barely detectible separation, localized separation, mostly separated, and complete separation (dehiscence). Question related to infection at surgical site had options: definitely, no infection, possibly infected, probably infected, certainly infected, and abscess/gross cellulitis. Question related to prescription of postoperative systemic antibiotics had options: no, yes for prophylaxis, and yes for infection. Every question there was category "Not Done" for participants with no wound assessment other than the reason 'missing' and category "Missing", where participants were missing for wound assessment.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline Baseline (Day 1, immediately before dosing) 12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Change From Baseline in Heart Rate at Clinic Follow-up Visit Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days) Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days) An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study.
Change From Baseline in Respiratory Rate at Clinic Follow-up Visit Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days) Respiratory rate was measured after the participant had taken rest for 5 minutes.
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days) Physical examination included the assessment of general appearance, skin; HEENT; neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline Baseline (Day 1, immediately before dosing) Thrombophlebitis assessment evaluation was done using following grades: 0 equals to (=) no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination Study discharge/early termination (maximum up to Day 5) Thrombophlebitis assessment evaluation was done using following grades: 0= no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
UPMC-St. Margaret's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Tulane Univ. Medical Center
🇺🇸New Orleans, Louisiana, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Validity Research
🇺🇸Merriam, Kansas, United States
National Institute of Clinical Research
🇺🇸Los Angeles, California, United States
Lotus Clinical Research
🇺🇸Pasadena, California, United States
Jackson Hospital
🇺🇸Montgomery, Alabama, United States
American Clinical Research Services
🇺🇸Steamboat Springs, Colorado, United States
Albany Medical Center
🇺🇸Albany, New York, United States
North Coast Women's Care
🇺🇸Vista, California, United States
Teton Research, LLC
🇺🇸Little Rock, Arkansas, United States
University of Kansas Medical Center Department of Anesthesiology
🇺🇸Kansas City, Kansas, United States
Somerset Hospital
🇺🇸Somerset, Pennsylvania, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Ilumina Clinical Associates
🇺🇸Johnstown, Pennsylvania, United States
JRSI Foundation The center for Hip and Knee Surgery
🇺🇸Mooresville, Indiana, United States
Colorado Orthopedic Consultants
🇺🇸Englewood, Colorado, United States
Soapstone Center for Clinical Research
🇺🇸Decatur, Georgia, United States
Pensacola Research Consultants
🇺🇸Pensacola, Florida, United States
Scott & White Clinic / Texas A&M Health Science Center
🇺🇸Temple, Texas, United States
University of Orthopedics Center
🇺🇸Altoona, Pennsylvania, United States
Comprehensive Pain Specialists, PLLC
🇺🇸Hendersonville, Tennessee, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
Interventional Pain Management
🇺🇸San Antonio, Texas, United States
West Alabama Research, LLC
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Precision Trials
🇺🇸Phoenix, Arizona, United States
Florida Orthopedic Institute
🇺🇸Tampa, Florida, United States
Allegheny Pain Management
🇺🇸Altoona, Pennsylvania, United States
Pivotal Clinical Research
🇺🇸Peoria, Arizona, United States
Horizon Research Group
🇺🇸Mobile, Alabama, United States
Drug Research and Analysis Corp.
🇺🇸Montgomery, Alabama, United States
Vertex
🇺🇸Bakersfield, California, United States
Physicians Clinical Research
🇺🇸Laguna Hills, California, United States
Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital
🇺🇸Florence, Alabama, United States
Helen Keller Memorial Hospital
🇺🇸Sheffield, Alabama, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Orthopedic Associates of Hartford
🇺🇸Hartford, Connecticut, United States
American Clinical Research
🇺🇸Aurora, Colorado, United States
Sunrise Medical Research, Inc.
🇺🇸Lauderdale Lakes, Florida, United States
Great Falls Clinic, LLP
🇺🇸Great Falls, Montana, United States
UPMC Presbyterian-Shadyshide Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University Orthopedics Center
🇺🇸State College, Pennsylvania, United States