A clinical study to investigate the absorption, distribution, and elimination of Combogesic® IV, and to evaluate its safety in pediatric patients with acute pain.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aft Pharmaceuticals Limited

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2026-03-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AFT Pharmaceuticals Ltd

External identifiers

EU CT number

2025-524431-39-00

WHO UTN

U1111-1330-7239

ClinicalTrials.gov

NCT07225634

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety

Determine the safety and pharmacokinetics of Combogesic® IV in children and adolescents between the ages of 2 and <17 years.

Secondary objectives 3

1. Measure pediatric patient’s global evaluation of the study drug
2. Define the pharmacokinetic parameters of Combogesic® IV in pediatric patients
3. Measure the consumption of supplemental opioid medication following Combogesic IV administration in pediatric patients

Conditions and MedDRA coding

Acute pain

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Is male or female aged between 2 and <17 years.
2. Have a clinical indication of acute pain requiring hospitalization and multiple doses of parenterally administered nonopioid analgesic medication for at least 0.5 - 5 days.
3. Is either able to provide written informed consent or consent is provided from parents/legal guardians and assent provided from participants (where appropriate).
4. Is willing and able to remain at the study site for at least 12 hours and to attend a follow-up visit at 7 ± 2 days after the last dose of study drug.
5. Have negative HIV and hepatitis B & C test results.

Exclusion criteria 16

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Is considered by the Investigator, for any reason to be an unsuitable candidate to receive the study drug.
8. 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).
9. Is currently receiving anticoagulants (e.g. heparin or warfarin).
10. 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).
11. 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.
12. 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).
13. Has any clinically significant laboratory finding at screening that, in the opinion of the Investigator, contraindicates study participation.
14. Participated in another clinical study within 30 days before Screening.
15. Pregnant or lactating females
16. Sexually active females of childbearing potential not using adequate contraception** and sexually active males not using adequate contraception

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The incidence of treatment-emergent adverse events associated with exposure to Combogesic® IV.

Secondary endpoints 8

1. The time course of treatment-emergent adverse events
2. The incidence of treatment-related adverse events
3. The incidence of treatment-emergent adverse events of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events)
4. Changes in vital sign measurements
5. Changes in clinical laboratory values
6. Patient’s global evaluation of the study drug
7. Define the pharmacokinetic parameters of Combogesic® IV including: Cmax, Tmax, t½, AUC(0-t), Extrapolated AUC(0-∞)
8. Consumption of supplemental opioid medication in each 24-hour period as Morphine Milligram Equivalent (MME).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aft Pharmaceuticals Limited

Sponsor organisation

Aft Pharmaceuticals Limited

Address

Level 1, Nielsen Centre, 129 Hurstmere Road, Takapuna Nielsen Centre 129 Hurstmere Road

City

Auckland

Postcode

0622

Country

New Zealand

Scientific contact point

Organisation

Aft Pharmaceuticals Limited

Contact name

Chief Scientific Officer

Public contact point

Organisation

Aft Pharmaceuticals Limited

Contact name

Chief Scientific Officer

Third parties 5

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications