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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DIC075V (intravenous diclofenac sodium)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring safety, diclofenac, pain, postoperative

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • West Alabama Research, LLC
  • Alabama Clinical Therapeutics
  • Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital
  • Horizon Research Group
  • Drug Research and Analysis Corp.
  • Jackson Hospital
  • Helen Keller Memorial Hospital
  • Pivotal Clinical Research
  • Precision Trials
  • Teton Research, LLC
  • Vertex
  • Lotus Clinical Research
  • Physicians Clinical Research
  • National Institute of Clinical Research
  • Lotus Clinical Research
  • Santa Barbara Cottage Hospital
  • North Coast Women's Care
  • American Clinical Research
  • Colorado Orthopedic Consultants
  • American Clinical Research Services
  • Orthopedic Associates of Hartford
  • Nature Coast Clinical Research
  • Sunrise Medical Research, Inc.
  • Pensacola Research Consultants
  • Florida Orthopedic Institute
  • Soapstone Center for Clinical Research
  • JRSI Foundation The center for Hip and Knee Surgery
  • University of Kansas Medical Center Department of Anesthesiology
  • Validity Research
  • Tulane Univ. Medical Center
  • Great Falls Clinic, LLP
  • Albany Medical Center
  • Staten Island University Hospital
  • The Ohio State University Medical Center
  • Allegheny Pain Management
  • University of Orthopedics Center
  • Ilumina Clinical Associates
  • Ilumina Clinical Associates
  • UPMC Presbyterian-Shadyshide Hospital
  • UPMC-St. Margaret's Hospital
  • Somerset Hospital
  • University Orthopedics Center
  • Comprehensive Pain Specialists, PLLC
  • Endeavor Clinical Trials
  • Interventional Pain Management
  • Scott & White Clinic / Texas A&M Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days

Outcomes

Primary Outcome Measures

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.
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.
Number of Participants With Abnormal Urinalysis Findings
Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.
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.
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.
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.
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.
Change From Baseline in Respiratory Rate at Study Discharge/Early Termination
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Change From Baseline in Respiratory Rate at Clinic Follow-up Visit
Respiratory rate was measured after the participant had taken rest for 5 minutes.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2008
Last Updated
September 15, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00726388
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2008 (Actual)
Primary Completion Date
May 8, 2009 (Actual)
Study Completion Date
May 8, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
safety, diclofenac, pain, postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1050 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days
Intervention Type
Drug
Intervention Name(s)
DIC075V (intravenous diclofenac sodium)
Intervention Description
multiple doses up to 5 days
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
Title
Number of Participants Who Took at Least 1 Concomitant Medication
Description
Concomitant medications were medications that were taken concurrently on or after first dose of study drug.
Time Frame
Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
Title
Number of Participants With Abnormal Urinalysis Findings
Description
Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.
Time Frame
Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5)
Title
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline
Description
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Time Frame
Baseline (Day 1, immediately before dosing)
Title
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination
Description
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Time Frame
Study discharge/early termination (maximum up to Day 5)
Title
Change From Baseline in Blood Pressure at Study Discharge/Early Termination
Description
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.
Time Frame
Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Title
Change From Baseline in Blood Pressure at Clinic Follow-up Visit
Description
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.
Time Frame
Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Title
Change From Baseline in Respiratory Rate at Study Discharge/Early Termination
Description
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Time Frame
Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Title
Change From Baseline in Respiratory Rate at Clinic Follow-up Visit
Description
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Time Frame
Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Title
Change From Baseline in Heart Rate at Study Discharge/Early Termination
Description
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.
Time Frame
Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Title
Change From Baseline in Heart Rate at Clinic Follow-up Visit
Description
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.
Time Frame
Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Title
Number of Participants With Wound Assessment at Study Discharge/Early Termination
Description
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.
Time Frame
Study discharge/early termination (maximum up to Day 5)
Title
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline
Description
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.
Time Frame
Baseline (Day 1, immediately before dosing)
Title
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination
Description
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.
Time Frame
Study discharge/early termination (maximum up to Day 5)
Title
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening
Description
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.
Time Frame
Screening (0 to 21 days prior to surgery)
Title
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit
Description
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.
Time Frame
Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
West Alabama Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital
City
Florence
State/Province
Alabama
ZIP/Postal Code
35630
Country
United States
Facility Name
Horizon Research Group
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Drug Research and Analysis Corp.
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Jackson Hospital
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Helen Keller Memorial Hospital
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Pivotal Clinical Research
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Precision Trials
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Teton Research, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Vertex
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
Facility Name
Lotus Clinical Research
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Physicians Clinical Research
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
National Institute of Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Lotus Clinical Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
North Coast Women's Care
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
American Clinical Research
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Colorado Orthopedic Consultants
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
American Clinical Research Services
City
Steamboat Springs
State/Province
Colorado
ZIP/Postal Code
80487
Country
United States
Facility Name
Orthopedic Associates of Hartford
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Sunrise Medical Research, Inc.
City
Lauderdale Lakes
State/Province
Florida
Country
United States
Facility Name
Pensacola Research Consultants
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Florida Orthopedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Soapstone Center for Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
33034
Country
United States
Facility Name
JRSI Foundation The center for Hip and Knee Surgery
City
Mooresville
State/Province
Indiana
ZIP/Postal Code
46158
Country
United States
Facility Name
University of Kansas Medical Center Department of Anesthesiology
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Validity Research
City
Merriam
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Tulane Univ. Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70113
Country
United States
Facility Name
Great Falls Clinic, LLP
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Allegheny Pain Management
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
University of Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Ilumina Clinical Associates
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15504
Country
United States
Facility Name
Ilumina Clinical Associates
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15904
Country
United States
Facility Name
UPMC Presbyterian-Shadyshide Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC-St. Margaret's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Somerset Hospital
City
Somerset
State/Province
Pennsylvania
ZIP/Postal Code
15501
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Comprehensive Pain Specialists, PLLC
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Interventional Pain Management
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Scott & White Clinic / Texas A&M Health Science Center
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29492863
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.
Results Reference
derived

Learn more about this trial

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

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