An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: DIC075V (intravenous diclofenac sodium)

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.

• Study Type: Interventional
• Enrollment (Actual): 1050
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics
    • Birmingham, Alabama, United States, 35209
      • West Alabama Research, Llc
    • Florence, Alabama, United States, 35630
      • Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital
    • Mobile, Alabama, United States, 36608
      • Horizon Research Group
    • Montgomery, Alabama, United States, 36106
      • Jackson Hospital
    • Montgomery, Alabama, United States, 36106
      • Drug Research and Analysis Corp.
    • Sheffield, Alabama, United States, 35660
      • Helen Keller Memorial Hospital
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Pivotal Clinical Research
    • Phoenix, Arizona, United States, 85032
      • Precision Trials
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Teton Research, LLC
  • California
    • Bakersfield, California, United States, 93311
      • Vertex
    • Glendale, California, United States, 91206
      • Lotus Clinical Research
    • Laguna Hills, California, United States, 92653
      • Physicians Clinical Research
    • Los Angeles, California, United States, 90017
      • National Institute of Clinical Research
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
    • Vista, California, United States, 92083
      • North Coast Women's Care
  • Colorado
    • Aurora, Colorado, United States
      • American Clinical Research
    • Englewood, Colorado, United States, 80110
      • Colorado Orthopedic Consultants
    • Steamboat Springs, Colorado, United States, 80487
      • American Clinical Research Services
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Orthopedic Associates of Hartford
  • Florida
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research
    • Lauderdale Lakes, Florida, United States
      • Sunrise Medical Research, Inc.
    • Pensacola, Florida, United States, 32504
      • Pensacola Research Consultants
    • Tampa, Florida, United States, 33637
      • Florida Orthopedic Institute
  • Georgia
    • Decatur, Georgia, United States, 33034
      • Soapstone Center for Clinical Research
  • Indiana
    • Mooresville, Indiana, United States, 46158
      • JRSI Foundation The center for Hip and Knee Surgery
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Department of Anesthesiology
    • Merriam, Kansas, United States, 66204
      • Validity Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70113
      • Tulane Univ. Medical Center
  • Montana
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic, LLP
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Allegheny Pain Management
    • Altoona, Pennsylvania, United States, 16602
      • University of Orthopedics Center
    • Johnstown, Pennsylvania, United States, 15904
      • Ilumina Clinical Associates
    • Johnstown, Pennsylvania, United States, 15504
      • Ilumina Clinical Associates
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Presbyterian-Shadyshide Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC-St. Margaret's Hospital
    • Somerset, Pennsylvania, United States, 15501
      • Somerset Hospital
    • State College, Pennsylvania, United States, 16801
      • University Orthopedics Center
  • Tennessee
    • Hendersonville, Tennessee, United States, 37075
      • Comprehensive Pain Specialists, PLLC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials
    • San Antonio, Texas, United States, 78258
      • Interventional Pain Management
    • Temple, Texas, United States, 76508
      • Scott & White Clinic / Texas A&M Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days	Drug: DIC075V (intravenous diclofenac sodium); multiple doses up to 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	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.	Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
Number of Participants Who Took at Least 1 Concomitant Medication	Concomitant medications were medications that were taken concurrently on or after first dose of study drug.	Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
Number of Participants With Abnormal Urinalysis Findings	Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.	Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5)
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline	12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.	Baseline (Day 1, immediately before dosing)
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination	12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.	Study discharge/early termination (maximum up to Day 5)
Change From Baseline in Blood Pressure at Study Discharge/Early Termination	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.	Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Change From Baseline in Blood Pressure at Clinic Follow-up Visit	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.	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 Respiratory Rate at Study Discharge/Early Termination	Respiratory rate was measured after the participant had taken rest for 5 minutes.	Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Change From Baseline in Respiratory Rate at Clinic Follow-up Visit	Respiratory rate was measured after the participant had taken rest for 5 minutes.	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 at Study Discharge/Early Termination	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.	Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Change From Baseline in Heart Rate at Clinic Follow-up Visit	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.	Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Number of Participants With Wound Assessment at Study Discharge/Early Termination	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.	Study discharge/early termination (maximum up to Day 5)
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline	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.	Baseline (Day 1, immediately before dosing)
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination	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.	Study discharge/early termination (maximum up to Day 5)
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening	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.	Screening (0 to 21 days prior to surgery)
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit	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.	Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2008
• Primary Completion (Actual): May 8, 2009
• Study Completion (Actual): May 8, 2009

Study Registration Dates

• First Submitted: July 29, 2008
• First Submitted That Met QC Criteria: July 30, 2008
• First Posted (Estimate): July 31, 2008

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: safety; pain, postoperative; diclofenac
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: DFC-010; C1211011 (Other Identifier: Alias Study Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes