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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04005755




Registration number
NCT04005755
Ethics application status
Date submitted
19/06/2019
Date registered
2/07/2019

Titles & IDs
Public title
Maxigesic® IV Phase 3 Exposure Study
Scientific title
A Phase 3, Open-Label, Multiple-Dose, Single-Arm Exposure Study of Maxigesic® IV in Patients With Acute Pain Following Orthopedic, General or Plastic Surgery
Secondary ID [1] 0 0
AFT-MXIV-11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Maxigesic® IV

Experimental: Maxigesic® IV - Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.


Treatment: Drugs: Maxigesic® IV
acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of TEAEs (Treatment-emergent Adverse Events)
Timepoint [1] 0 0
During treatment period (= 48 hours - 5 days)
Secondary outcome [1] 0 0
Time Course of TEAEs
Timepoint [1] 0 0
After receiving the first dose of study medication until 7 days after the last dose, a total of approximately 9 days for subjects who received the treatment for 48 hours and 12 days for subjects who received the treatment for 5 days.
Secondary outcome [2] 0 0
Incidence of TRAEs (Treatment-related Adverse Events)
Timepoint [2] 0 0
During treatment period (= 48 hours - 5 days)
Secondary outcome [3] 0 0
Incidence of TEAEs of Interest
Timepoint [3] 0 0
During treatment period (= 48 hours - 5 days)
Secondary outcome [4] 0 0
Changes in Blood Pressure
Timepoint [4] 0 0
From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Secondary outcome [5] 0 0
Changes in Heart Rate
Timepoint [5] 0 0
From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Secondary outcome [6] 0 0
Changes in Temperature
Timepoint [6] 0 0
From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Secondary outcome [7] 0 0
Changes in Respiratory Rate
Timepoint [7] 0 0
From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Secondary outcome [8] 0 0
Changes in Hematology Values (Hemoglobin)
Timepoint [8] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [9] 0 0
Changes in Hematology Values (Hematocrit)
Timepoint [9] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [10] 0 0
Changes in Hematology Values (Platelet Count)
Timepoint [10] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [11] 0 0
Changes in Hematology Values (Red Blood Cell Count)
Timepoint [11] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [12] 0 0
Changes in Hematology Values (White Blood Cell Count)
Timepoint [12] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [13] 0 0
Changes in Hematology Values (Differential Leukocyte Count)
Timepoint [13] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [14] 0 0
Changes in Blood Biochemistry Values (Sodium)
Timepoint [14] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [15] 0 0
Changes in Blood Biochemistry Values (Potassium)
Timepoint [15] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [16] 0 0
Changes in Blood Biochemistry Values (Urea)
Timepoint [16] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [17] 0 0
Changes in Blood Biochemistry Values (Creatinine)
Timepoint [17] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [18] 0 0
Changes in Blood Biochemistry Values (Phosphate)
Timepoint [18] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [19] 0 0
Changes in Blood Biochemistry Values (Glucose)
Timepoint [19] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [20] 0 0
Changes in Blood Biochemistry Values (Albumin)
Timepoint [20] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [21] 0 0
Changes in Blood Biochemistry Values (Total Protein)
Timepoint [21] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [22] 0 0
Changes in Blood Biochemistry Values (Alkaline Phosphates)
Timepoint [22] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [23] 0 0
Changes in Blood Biochemistry Values (Gamma-glutamyl Transferase)
Timepoint [23] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [24] 0 0
Changes in Blood Biochemistry Values (Aspartate Transaminase)
Timepoint [24] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [25] 0 0
Changes in Blood Biochemistry Values (Alanine Transaminase)
Timepoint [25] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [26] 0 0
Changes in Blood Biochemistry Values (Bilirubin)
Timepoint [26] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [27] 0 0
Changes in ECG (Electrocardiography) Status (Normal/Abnormal)
Timepoint [27] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [28] 0 0
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Timepoint [28] 0 0
Prior to surgery, on Day 1 and at discharge (Day 5)
Secondary outcome [29] 0 0
Patient's Global Evaluation of the Study Drug
Timepoint [29] 0 0
5 days after the first dose

Eligibility
Key inclusion criteria
* Is male or female = 18 years of age.
* Is classified by the anesthesiologist as P1 to P2 in the American Society of Anesthesiologists (ASA) Physical Status Classification System.
* Requires multiple doses of parenterally administered nonopioid analgesics over multiple days as a result of surgery (non-laparoscopic general, plastic or orthopedic surgery).
* Has an expected stay in facility = 48 hours.
* Has a body weight = 45 kg.
* If female and of childbearing potential, is nonlactating and nonpregnant.
* If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following medically acceptable methods of birth control: i) Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before study drug administration; ii) Total abstinence from sexual intercourse since the last menses before study drug administration through completion of final study visit; iii) Intrauterine device (IUD); iv) Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
* Is able to provide written informed consent to participate in the study and able to understand the procedures and study requirements.
* Must voluntarily sign and date an informed consent form (ICF) that is approved by an Institutional Review Board (IRB) before the conduct of any study procedure.
* Is willing and able to remain at the study site for at least 48 hours and to attend a follow-up visit at 7 ± 2 days after the last dose of study drug.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen); history of NSAID-induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any other drugs used in the study including anesthetics and antibiotics that may be required on the day of surgery.
* Has experienced any surgical complications or other issues that, in the opinion of the Investigator, could compromise the safety of the subject if he or she participates in the study or could confound the results of the study.
* Has a known or suspected history of alcoholism or drug abuse or misuse within 2 years of screening or evidence of tolerance or physical dependence before dosing with study drug.
* Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease or any other condition that, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
* Has a history or current diagnosis of a significant psychiatric disorder that, in the opinion of the Investigator, would affect the subject's ability to comply with the study requirements.
* Has tested positive either on the urine drug screen or on the alcohol breathalyzer test. Subjects who test positive and can produce a prescription for the medication from their physician may be considered for study enrolment at the discretion of the Investigator.
* Has a history of a clinically significant (Investigator opinion) gastrointestinal (GI) event within 6 months before screening or has any history of peptic or gastric ulcers or GI bleeding.
* Has a surgical or medical condition of the GI or renal system that might significantly alter the absorption, distribution, or excretion of any drug substance.
* Is considered by the Investigator, for any reason to be an unsuitable candidate to receive the study drug.
* Is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding treated squamous or basal cell carcinoma of the skin).
* Is currently receiving anticoagulants (e.g. heparin or warfarin).
* Has received a course of systemic corticosteroids (either oral or parenteral) within 3 months before screening (inhaled nasal steroids and regional/limited area application of topical corticosteroids (Investigator discretion) are allowed).
* Has a history of chronic use (defined as daily use for > 2 weeks) of NSAIDs, opiates, or glucocorticoids (except inhaled nasal steroids and regional/limited topical corticosteroids), for any condition within 6 months before study drug administration. Aspirin at a daily dose of = 325 mg is allowed for cardiovascular prophylaxis if the subject has been on a stable dose regimen for = 30 days before screening and has not experienced any relevant medical problem.
* Has a significant renal or hepatic disease, as indicated by clinical laboratory assessment (results = 3 times the upper limit of normal [ULN] for any liver function test, including aspartate aminotransferase [AST], alanine aminotransferase [ALT], or creatinine = 1.5 times the ULN).
* Has any clinically significant laboratory finding at screening that, in the opinion of the Investigator, contraindicates study participation.
* Previously participated in another clinical study of Maxigesic® IV or received any investigational drug or device or investigational therapy within 30 days before Screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/07/2020
Sample size
Target
Accrual to date
Final
232
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AFT Pharmaceuticals, Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ira Gottlieb, DPM
Address 0 0
Chesapeake Research Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04005755