Post Operative Pain, AcutePhase 3NCT07225140
A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery
A Phase 3 study testing Combogesic® tablets and Acetaminophen 500mg in people with Post Operative Pain, Acute, run by AFT Pharmaceuticals, Ltd. at 1 site in United States.
Trial summary
Combogesic® 325 contains a combination of ibuprofen and acetaminophen. The purpose of this study is to compare the pain relief effects of Combogesic® 325mg and acetaminophen and to evaluate the safety of Combogesic® 325mg in adolescents between the ages of 12 and <18 years. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Combogesic® tablets and Acetaminophen 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Provide written informed consent or consent be provided from parents/legal guardians and assent from participants (where appropriate).
- Be males and females aged at least 12 years and less than 18 years old on both the day of consent and throughout the 24 hour study period.
- Be undergoing planned orthopedic surgery which requires at least 24 hours of hospital inpatient stay.
- Have a clinical indication of acute moderate or severe pain (at least ≥ 50 mm on the VAS scale*) within 6 hours after the completion of surgery associated with orthopedic surgery.
- using a 100mm VAS scale with 0 = no pain and 100 = worst pain imaginable, patients should have a resting VAS pain intensity score of ≥ 50 mm for inclusion. For this study, moderate pain is defined as ≥ 40 mm to ≤ 69 mm and severe pain is defined as a resting VAS of ≥ 70 mm to ≤ 100 mm.
- Have negative HIV and hepatitis B \& C test results.
Who cannot join
- Has taken any NSAID or acetaminophen containing drug products within 5 half-lives prior to the initial dose of study drug.
- Hypersensitivity to opioids, NSAIDs or acetaminophen or a history of severe/serious drug reaction to NSAIDs or acetaminophen.
- Pregnant or lactating females Known to be pregnant or possibly pregnant.
- Sexually active females of childbearing potential not using adequate contraception* and sexually active males not using adequate contraception**
- Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence (should the participant become sexually active, she must agree to use a double-barrier method of contraception). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral oophorectomy.
- Women of childbearing potential who are unwilling to undergo a urine pregnancy test.
Show all 17Show fewer
- Suffering from a neurological disorder relating to pain perception or any acute or chronic condition that, in the opinion of the Investigator, makes the participant unsuitable from an efficacy or safety perspective.
- In the opinion of the Investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.
- Currently or in last 30 days, has been in a clinical trial involving another study drug.
- Have donated blood or blood products within 30 days prior to study drug administration
- Advanced renal impairment (serum creatinine >132 µmol/L) or a risk for renal failure due to volume depletion.
- Severe known haemopoietic, renal or hepatic disease, or immunosuppressed, including any clinically significant finding from the laboratory tests results (biochemistry and hematology at screening), which, in the opinion of the Investigator, means that it would not be in the participants' best interests to participate in this study.
- History of gastric ulceration or other GI disorders that, in the opinion of the Investigator make the participant unsuitable (e.g. frequent treatment of gastroesophageal reflux disease, inflammatory bowel disease, etc).
- History of severe asthma in the opinion of the investigator.
- Has a history of drug or alcohol abuse
- Suffering from any other disease or condition which, in the opinion of the Investigator, means that it would not be in the participant's best interests to participate in this study.
- Methods of contraception that are deemed adequate have failure rates of < 1%, including: established use of oral contraceptives in conjunction with a barrier method of contraception; injected or implanted hormonal methods of contraception; placement of intrauterine device (IUD) or intrauterine system (IUS); sexual abstinence; hysterectomy; post-menopausal; sterilized; vasectomy. Suitable contraception should be used for the entire study period, from screening to follow-up. Women of childbearing age include all women that have begun puberty and had their first menstrual period until they reach menopause.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nemours Children's Health
Orlando, Florida, 32827
Lisgelia Santana-Rojas, 4076507715
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel Group, Active-controlled, Dose-ranging Study to Assess Efficacy, Safety, and Pharmacokinetics of Combogesic® 325 in Adolescent Patients (Aged 12 to Less Than 18 Years) With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery
Combogesic® 325 contains a combination of ibuprofen and acetaminophen. The purpose of this study is to compare the pain relief effects of Combogesic® 325mg and acetaminophen and to evaluate the safety of Combogesic® 325mg in adolescents between the ages of 12 and <18 years.
What will the study involve for participants?
Read more
- Participants will be randomly allocated to one of 3 treatment groups:
- 3 tablets of Combogesic® 325,
- 2 tablets of Combogesic® 325 and 1 tablet of placebo or
- 2 tablets of acetaminophen1000mg and 1 tablet of placebo
- Participants will take 3 tablets every 6 hours with a maximum of 4 doses in 24 hours
- Participants and study doctor will be blinded to the treatment group
- If pain is not sufficiently controlled, opioids may be used as supplementary pain relief at the discretion of the study doctor.
- Participants will complete a patient diary to assess their pain
- Participants will rate the study drug at the end of the treatment.
It is expected that Combogesic® tablets (either 2 or 3 tablets per dose) will provide a greater reduction in pain compared to acetaminophen (1000 mg) treatment.
- Conditions
- Post Operative Pain, Acute
- Being tested
- Combogesic® tablets, Acetaminophen 500mg, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combogesic® tabletsDrug
Also called Acetaminophen 325 mg and ibuprofen 97.5 mg
The active ingredients of Combogesic® tablets are acetaminophen 325 mg and ibuprofen 97.5 mg.
Acetaminophen 500mgDrug
Each tablet contains acetaminophen 500mg.
PlaceboDrug
Placebo tablets do not contain any active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Treatment A- 3 tablets of Combogesic® tablets | Experimental | 3 tablets of Combogesic® (acetaminophen 975mg + ibuprofen 292.5 mg, total per dose) will be administered every 6 hours up to a maximum of 4 doses in 24 hours. Receives: Drug: Combogesic® tablets |
| Treatment B- 2 tablets of Combogesic® + 1 tablets of placebo | Experimental | 2 tablets of Combogesic® (acetaminophen 650 mg + ibuprofen 195 mg, total per dose) and 1 tablet of placebo will be administered every 6 hours up to a maximum of 4 doses in 24 hours. Receives: Drug: Combogesic® tablets; Drug: Placebo |
| Treatment C - 2 tablets of acetaminophen and 1 tablet of placebo | Active comparator | 2 tablets of acetaminophen (1000 mg total per dose) + 1 tablet of placebo will be administered every 6 hours up to a maximum of 4 doses in 24 hours. Receives: Drug: Acetaminophen 500mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-adjusted summed pain intensity difference (SPID) calculated from the visual analogue scale (VAS) pain intensity scores 6 hours after first dose of study medication
SPID will be derived from the 100 mm Visual Analogue Scale which is the tool used for patients to rate the intensity of their pain on a horizontal 100mm line with 0 on one end and 100 on the other end (0 being no pain and 100 being the worst pain unimaginable). The primary analysis will compare three tablets of Combogesic® against acetaminophen
Measured: From start of exposure to study drug until 6 hours after first dose
Secondary outcomes (22)
Time-adjusted SPID0-6 (for 2 tablets of Combogesic vs. acetaminophen) and Time-adjusted SPID0-12, SPID0-18 and SPID0-24 for both doses.
Measured: From start of exposure to study medication up to 24 hours
The time to onset of pain relief after the first dose of study drug defined as (i) perceptible, (ii) meaningful and (iii) complete pain relief using the three stopwatch method.
Measured: From start of exposure to study medication up to 24 hours
The maximum VAS pain scores up to 24 hours after the first dose of study medication.
100 mm Visual Analogue Scale is the tool used for patients to rate the intensity of their pain on a horizontal 100mm line with 0 on one end and 100 on the other end (0 being no pain and 100 being the worst pain unimaginable)
Measured: From start of exposure to study medication up to 24 hours
The pain intensity (PI) and pain intensity difference (PID) at 6, 12, 18, and 24 hours after first dose.
100 mm Visual Analogue Scale which is the tool used for patients to rate the intensity of their pain on a horizontal 100mm line with 0 on one end and 100 on the other end (0 being no pain and 100 being the worst pain unimaginable). The PID will be measured by the difference between the baseline score and the score at 6, 12, 18, and 24 hours after first dose.
Measured: From start of exposure to study medication up to 24 hours
Pain relief as measured on a 5-point categorical scale at 6, 12, 18, and 24 hours after first dose.
Patients will be asked to rate their pain in their patient diary with the following questionnaire.
Please rate your pain relief:
0= no pain relief; (the pain is the same, or worse, than the starting pain)
- a little pain relief; (the pain is less than half gone)
- some pain relief; (the pain is about half gone)
- a lot of pain relief; (the pain is more than half gone)
- complete pain relief; (the pain is completely gone)
Measured: From start of exposure to study medication up to 24 hours
Peak pain relief
Measured: From start of exposure to study medication up to 24 hours
Time to peak pain relief
Measured: From start of exposure to study medication up to 24 hours
Total pain relief (TOTPAR) (calculated as a time-weighted average) over 0-6 hours (TOTPAR-6), over 0-12 hours (TOTPAR-12), over 0-18 hours (TOTPAR-18), and over 0-24 hours (TOTPAR-24).
Measured: From start of exposure to study medication up to 24 hours
The response rates (response rate to be defined as the percentage of participants who reduce their pain intensity scores by at least 50% compared with the baseline VAS measure).
Measured: From start of exposure to study medication up to 24 hours
Time to response
Measured: From start of exposure to study medication up to 24 hours
The time to requirement for rescue medication.
Measured: From start of exposure to study medication up to 24 hours
The percentage of participants using rescue medication at 6, 12, 18, and 24 hours after first dose.
Measured: From start of exposure to study medication up to 24 hours
Total Dose (mg) of primary (oxycodone) and secondary (morphine) rescue medication over 24 hours
Measured: From start of exposure to study medication up to 24 hours
Total oral Morphine Milligram Equivalent (MME) dose of all rescue medication over the 24 hour study period
Measured: From start of exposure to study medication up to 24 hours
The categorical global evaluation of study drug.
Each patient will rate the study medication using a questionnaire of: How do you rate the study medication? 1 = Poor; 2 = Fair; 3 = Good; 4 = Very Good; 5 = Excellent The patient's global evaluation of the study drug will be summarized by the number and percentage of subjects within each category.
Measured: From start of exposure to study medication up to 24 hours
To compare treatment-emergent adverse event (TEAE) rates over the course of treatment and at a follow up call 7 days after last dose.
Measured: From start of exposure to study medication until 7 days after last dose
The incidence of specific NSAID and acetaminophen adverse effects from the first dose of study drug until Day 7.
Adverse effects include GI ulceration or bleeding, indigestion/stomach pain, post-operative bleeding, bronchospasm, skin reactions, water retention, renal failure, thromboembolic events, and evidence of clinical hepatitis
Measured: From start of exposure to study medication until 7 days after final dose
To characterize the pharmacokinetic profile of two different doses of Combogesic® 325 (T1/2- Time required for the plasma drug concentration to decrease by one half)
This will be defined from the plasma concentration versus time data using non-compartmental methods
Measured: Approximately 15 minutes before first dose of study medication until 6 hours after first study medication administration and before second dose
To characterize the pharmacokinetic profile of two different doses of Combogesic® 325 (Extrapolated AUC(0-∞)- The area under the plasma concentration versus time curve, from zero to infinity)
This will be defined from the plasma concentration versus time data using non-compartmental methods
Measured: Approximately 15 minutes before first dose of study medication until 6 hours after first study medication administration and before second dose
To characterize the pharmacokinetic profile of two different doses of Combogesic® 325 (Cmax- Maximum measured plasma concentration)
This will be defined from the plasma concentration versus time data using non-compartmental methods
Measured: Approximately 15 minutes before first dose of study medication until 6 hours after first study medication administration and before second dose
To characterize the pharmacokinetic profile of two different doses of Combogesic® 325 (Tmax- Time to maximum measured plasma concentration)
This will be defined from the plasma concentration versus time data using non-compartmental methods
Measured: Approximately 15 minutes before first dose of study medication until 6 hours after first study medication administration and before second dose
To characterize the pharmacokinetic profile of two different doses of Combogesic® 325 (AUC(0-t) - The area under the plasma concentration versus time curve from time zero to the last measurable concentration)
This will be defined from the plasma concentration versus time data using non-compartmental methods
Measured: Approximately 15 minutes before first dose of study medication until 6 hours after first study medication administration and before second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AFT Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225140
- Sponsor's protocol ID
- AFT-MX-16p
- Status last verified
- Jun 2026
- First submitted
- 30 Oct 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel Group, Active-controlled, Dose-ranging Study to Assess Efficacy, Safety, and Pharmacokinetics of Combogesic® 325 in Adolescent Patients (Aged 12 to Less Than 18 Years) With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07225140
- Acronym / sponsor ID
- AFT-MX-16p
- Conditions
- Post Operative Pain, Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- AFT Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 5 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Combogesic® 325 contains a combination of ibuprofen and acetaminophen. The purpose of this study is to compare the pain relief effects of Combogesic® 325mg and acetaminophen and to evaluate the safety of Combogesic® 325mg in adolescents between the ages of 12 and <18 years.
What will the study involve for participants?
- Participants will be randomly allocated to one of 3 treatment groups:
- 3 tablets of Combogesic® 325,
- 2 tablets of Combogesic® 325 and 1 tablet of placebo or
- 2 tablets of acetaminophen1000mg and 1 tablet of placebo
- Participants will take 3 tablets every 6 hours with a maximum of 4 doses in 24 hours
- Participants and study doctor will be blinded to the treatment group
- If pain is not sufficiently controlled, opioids may be used as supplementary pain relief at the discretion of the study doctor.
- Participants will complete a patient diary to assess their pain
- Participants will rate the study drug at the end of the treatment.
It is expected that Combogesic® tablets (either 2 or 3 tablets per dose) will provide a greater reduction in pain compared to acetaminophen (1000 mg) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A- 3 tablets of Combogesic® tablets | Experimental | Drug: Combogesic® tablets3 tablets of Combogesic® (acetaminophen 975mg + ibuprofen 292.5 mg, total per dose) will be administered every 6 hours up to a maximum of 4 doses in 24 hours. |
| Treatment B- 2 tablets of Combogesic® + 1 tablets of placebo | Experimental | Drug: Combogesic® tablets, Drug: Placebo2 tablets of Combogesic® (acetaminophen 650 mg + ibuprofen 195 mg, total per dose) and 1 tablet of placebo will be administered every 6 hours up to a maximum of 4 doses in 24 hours. |
| Treatment C - 2 tablets of acetaminophen and 1 tablet of placebo | Active comparator | Drug: Acetaminophen 500mg, Drug: Placebo2 tablets of acetaminophen (1000 mg total per dose) + 1 tablet of placebo will be administered every 6 hours up to a maximum of 4 doses in 24 hours. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Provide written informed consent or consent be provided from parents/legal guardians and assent from participants (where appropriate).
- Be males and females aged at least 12 years and less than 18 years old on both the day of consent and throughout the 24 hour study period.
- Be undergoing planned orthopedic surgery which requires at least 24 hours of hospital inpatient stay.
- Have a clinical indication of acute moderate or severe pain (at least ≥ 50 mm on the VAS scale*) within 6 hours after the completion of surgery associated with orthopedic surgery.
- using a 100mm VAS scale with 0 = no pain and 100 = worst pain imaginable, patients should have a resting VAS pain intensity score of ≥ 50 mm for inclusion. For this study, moderate pain is defined as ≥ 40 mm to ≤ 69 mm and severe pain is defined as a resting VAS of ≥ 70 mm to ≤ 100 mm.
Key exclusion criteria (17 listed)
- Has taken any NSAID or acetaminophen containing drug products within 5 half-lives prior to the initial dose of study drug.
- Hypersensitivity to opioids, NSAIDs or acetaminophen or a history of severe/serious drug reaction to NSAIDs or acetaminophen.
- Pregnant or lactating females Known to be pregnant or possibly pregnant.
- Sexually active females of childbearing potential not using adequate contraception* and sexually active males not using adequate contraception**
- Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence (should the participant become sexually active, she must agree to use a double-barrier method of contraception). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral oophorectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combogesic® tabletsAlso: Acetaminophen 325 mg and ibuprofen 97.5 mgThe active ingredients of Combogesic® tablets are acetaminophen 325 mg and ibuprofen 97.5 mg. | Drug | Treatment A- 3 tablets of Combogesic® tablets, Treatment B- 2 tablets of Combogesic® + 1 tablets of placebo |
| Acetaminophen 500mgEach tablet contains acetaminophen 500mg. | Drug | Treatment C - 2 tablets of acetaminophen and 1 tablet of placebo |
| PlaceboPlacebo tablets do not contain any active ingredients | Drug | Treatment B- 2 tablets of Combogesic® + 1 tablets of placebo, Treatment C - 2 tablets of acetaminophen and 1 tablet of placebo |
Primary outcome
Time-adjusted summed pain intensity difference (SPID) calculated from the visual analogue scale (VAS) pain intensity scores 6 hours after first dose of study medication
Time frame: From start of exposure to study drug until 6 hours after first dose
SPID will be derived from the 100 mm Visual Analogue Scale which is the tool used for patients to rate the intensity of their pain on a horizontal 100mm line with 0 on one end and 100 on the other end (0 being no pain and 100 being the worst pain unimaginable). The primary analysis will compare three tablets of Combogesic® against acetaminophen
22 secondary outcomes
Time-adjusted SPID0-6 (for 2 tablets of Combogesic vs. acetaminophen) and Time-adjusted SPID0-12, SPID0-18 and SPID0-24 for both doses.
Time frame: From start of exposure to study medication up to 24 hours
The time to onset of pain relief after the first dose of study drug defined as (i) perceptible, (ii) meaningful and (iii) complete pain relief using the three stopwatch method.
Time frame: From start of exposure to study medication up to 24 hours
The maximum VAS pain scores up to 24 hours after the first dose of study medication.
Time frame: From start of exposure to study medication up to 24 hours
The pain intensity (PI) and pain intensity difference (PID) at 6, 12, 18, and 24 hours after first dose.
Time frame: From start of exposure to study medication up to 24 hours
Pain relief as measured on a 5-point categorical scale at 6, 12, 18, and 24 hours after first dose.
Time frame: From start of exposure to study medication up to 24 hours
Peak pain relief
Time frame: From start of exposure to study medication up to 24 hours
Time to peak pain relief
Time frame: From start of exposure to study medication up to 24 hours
Total pain relief (TOTPAR) (calculated as a time-weighted average) over 0-6 hours (TOTPAR-6), over 0-12 hours (TOTPAR-12), over 0-18 hours (TOTPAR-18), and over 0-24 hours (TOTPAR-24).
Time frame: From start of exposure to study medication up to 24 hours
The response rates (response rate to be defined as the percentage of participants who reduce their pain intensity scores by at least 50% compared with the baseline VAS measure).
Time frame: From start of exposure to study medication up to 24 hours
Time to response
Time frame: From start of exposure to study medication up to 24 hours
The time to requirement for rescue medication.
Time frame: From start of exposure to study medication up to 24 hours
The percentage of participants using rescue medication at 6, 12, 18, and 24 hours after first dose.
Time frame: From start of exposure to study medication up to 24 hours
Total Dose (mg) of primary (oxycodone) and secondary (morphine) rescue medication over 24 hours
Time frame: From start of exposure to study medication up to 24 hours
Total oral Morphine Milligram Equivalent (MME) dose of all rescue medication over the 24 hour study period
Time frame: From start of exposure to study medication up to 24 hours
The categorical global evaluation of study drug.
Time frame: From start of exposure to study medication up to 24 hours
To compare treatment-emergent adverse event (TEAE) rates over the course of treatment and at a follow up call 7 days after last dose.
Time frame: From start of exposure to study medication until 7 days after last dose
The incidence of specific NSAID and acetaminophen adverse effects from the first dose of study drug until Day 7.
Time frame: From start of exposure to study medication until 7 days after final dose
To characterize the pharmacokinetic profile of two different doses of Combogesic® 325 (T1/2- Time required for the plasma drug concentration to decrease by one half)
Time frame: Approximately 15 minutes before first dose of study medication until 6 hours after first study medication administration and before second dose
To characterize the pharmacokinetic profile of two different doses of Combogesic® 325 (Extrapolated AUC(0-∞)- The area under the plasma concentration versus time curve, from zero to infinity)
Time frame: Approximately 15 minutes before first dose of study medication until 6 hours after first study medication administration and before second dose
To characterize the pharmacokinetic profile of two different doses of Combogesic® 325 (Cmax- Maximum measured plasma concentration)
Time frame: Approximately 15 minutes before first dose of study medication until 6 hours after first study medication administration and before second dose
To characterize the pharmacokinetic profile of two different doses of Combogesic® 325 (Tmax- Time to maximum measured plasma concentration)
Time frame: Approximately 15 minutes before first dose of study medication until 6 hours after first study medication administration and before second dose
To characterize the pharmacokinetic profile of two different doses of Combogesic® 325 (AUC(0-t) - The area under the plasma concentration versus time curve from time zero to the last measurable concentration)
Time frame: Approximately 15 minutes before first dose of study medication until 6 hours after first study medication administration and before second dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combogesic® tablets and Acetaminophen 500mg in people with Post Operative Pain, Acute, run by AFT Pharmaceuticals, Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Boddington (+64 9 488 0232 ext 735, laura.boddington@aftpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-adjusted summed pain intensity difference (SPID) calculated from the visual analogue scale (VAS) pain intensity scores 6 hours after first dose of study medication (time frame: From start of exposure to study drug until 6 hours after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.