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

NCT00726388 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: DFC-010C1211011
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 46

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.

Conditions

Pain, Postoperative

Keywords

safety; diclofenac; pain, postoperative

Outcome Measures

Primary Outcomes (16)

• 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)

Study Arms (1)

A

EXPERIMENTAL

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

Drug: DIC075V (intravenous diclofenac sodium)

Interventions

DIC075V (intravenous diclofenac sodium) DRUG

multiple doses up to 5 days

A

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Pfizer: lead

Study Sites (46)

West Alabama Research, LLC

Birmingham, Alabama, 35209, United States

Location

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital

Florence, Alabama, 35630, United States

Location

Horizon Research Group

Mobile, Alabama, 36608, United States

Location

Drug Research and Analysis Corp.

Montgomery, Alabama, 36106, United States

Location

Jackson Hospital

Montgomery, Alabama, 36106, United States

Location

Helen Keller Memorial Hospital

Sheffield, Alabama, 35660, United States

Location

Pivotal Clinical Research

Peoria, Arizona, 85381, United States

Location

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Teton Research, LLC

Little Rock, Arkansas, 72205, United States

Location

Vertex

Bakersfield, California, 93311, United States

Location

Lotus Clinical Research

Glendale, California, 91206, United States

Location

Physicians Clinical Research

Laguna Hills, California, 92653, United States

Location

National Institute of Clinical Research

Los Angeles, California, 90017, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

North Coast Women's Care

Vista, California, 92083, United States

Location

American Clinical Research

Aurora, Colorado, United States

Location

Colorado Orthopedic Consultants

Englewood, Colorado, 80110, United States

Location

American Clinical Research Services

Steamboat Springs, Colorado, 80487, United States

Location

Orthopedic Associates of Hartford

Hartford, Connecticut, 06106, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

Sunrise Medical Research, Inc.

Lauderdale Lakes, Florida, United States

Location

Pensacola Research Consultants

Pensacola, Florida, 32504, United States

Location

Florida Orthopedic Institute

Tampa, Florida, 33637, United States

Location

Soapstone Center for Clinical Research

Decatur, Georgia, 33034, United States

Location

JRSI Foundation The center for Hip and Knee Surgery

Mooresville, Indiana, 46158, United States

Location

University of Kansas Medical Center Department of Anesthesiology

Kansas City, Kansas, 66160, United States

Location

Validity Research

Merriam, Kansas, 66204, United States

Location

Tulane Univ. Medical Center

New Orleans, Louisiana, 70113, United States

Location

Great Falls Clinic, LLP

Great Falls, Montana, 59405, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Allegheny Pain Management

Altoona, Pennsylvania, 16602, United States

Location

University of Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

Ilumina Clinical Associates

Johnstown, Pennsylvania, 15504, United States

Location

Ilumina Clinical Associates

Johnstown, Pennsylvania, 15904, United States

Location

UPMC Presbyterian-Shadyshide Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC-St. Margaret's Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Somerset Hospital

Somerset, Pennsylvania, 15501, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Comprehensive Pain Specialists, PLLC

Hendersonville, Tennessee, 37075, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

Interventional Pain Management

San Antonio, Texas, 78258, United States

Location

Scott & White Clinic / Texas A&M Health Science Center

Temple, Texas, 76508, United States

Location

Related Publications (1)

• 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.

  PMID: 29492863 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: July 31, 2008
• Study Start: September 15, 2008
• Primary Completion: May 8, 2009
• Study Completion: May 8, 2009
• Last Updated: October 13, 2021
• Results First Posted: October 13, 2021

Record last verified: 2021-09

Locations

US (46)