Maxigesic® IV Phase 3 Exposure Study | NCT04005755

NCT04005755

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Maxigesic® IV	Experimental	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.	Drug: Maxigesic® IV

Name	Type	Description	Arm Group Labels	Other Names
Maxigesic® IV	Drug	acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion	Maxigesic® IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of TEAEs (Treatment-emergent Adverse Events)	The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV	During treatment period (≥ 48 hours - 5 days)

Secondary Outcomes

Measure	Description	Time Frame
Time Course of TEAEs	The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV during various study time periods	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.

Eligibility Module

Eligibility Criteria

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.

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.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Ira Gottlieb, DPM	Chesapeake Research Group	Principal Investigator
Simon Carson, MD	Southern Clinical Trials Ltd	Principal Investigator
Gregory L Ruff, MD	Chapel Hill Research Group	Principal Investigator
Nigel Gilchrist, MD	CGM Research Trust	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Chesapeake Reserach Group		Pasadena	Maryland	21122	United States
Chapel Hill Research Group

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	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. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000232 subjects
COMPLETED		FG000215 subjects
NOT COMPLETED		FG00017 subjects

Type	Comment	Reasons
Adverse Event		FG0006 subjects
Physician Decision		FG0003 subjects
Administrative reason, temporary site closure due to COVID-19		FG000

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence of TEAEs (Treatment-emergent Adverse Events)

The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Posted

Number

Treatment-Emergent Adverse Events

During treatment period (≥ 48 hours - 5 days)

ID	Title	Description
OG000	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. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	The subject experienced hypotension (primary event) resulting in hospitalization after receiving the second dose of study medication. blood pressure: 67/49mmHg. The SAE was evaluated as "unlikely related to the investigational product.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Infusion site pain	General disorders	MedDRA 10.0	Systematic Assessment	Infusion site pain

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Jennifer Zhang -Project Leader	AFT Pharmaceuticals	+ 64 9 488 0232	710	jenniferz@aftpharm.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 21, 2019	Jul 4, 2021	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Oct 7, 2020	Jul 4, 2021	SAP_001.pdf

Submission Tracking

Condition Browse Module

ID	Term
D010149	Pain, Postoperative

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Title	Measurements
	OG00034

Title	Measurements
	OG00025

Title	Measurements
	OG000-0.2± 0.5