Postoperative PainPhase 3NCT04005755
Maxigesic® IV Phase 3 Exposure Study
A Phase 3 study testing Maxigesic® IV in people with Postoperative Pain, run by AFT Pharmaceuticals, Ltd. at 4 sites in 2 countries.
Trial summary
The study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Maxigesic® IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 22 Jul 2019to 7 Jul 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Chapel Hill Research Group
Chapel Hill, North Carolina, 27514
Chesapeake Reserach Group
Pasadena, Maryland, 21122
New Zealand2 sites
Canterbury Geriatric Medical Research Trust
Christchurch, 8083
Southern Clinical Trials
Christchurch
About this study
Official 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
The study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure.
Read the detailed description
Combined administration of acetaminophen and ibuprofen has been shown to provide superior analgesia over administration of comparable doses of either component alone or placebo, when given as an intravenous formulation or as a solid oral tablet in the postoperative setting.
The superior efficacy of the combination does not appear to come at the expense of tolerability. A previous study of Maxigesic® IV in bunionectomy patients found that there were no differences between patients treated with repeated doses of Maxigesic® IV and those treated with intravenous acetaminophen, ibuprofen or placebo in the rate of discontinuations due to adverse events (AEs), the overall incidence of treatment-emergent AEs (TEAEs) or the severity of TEAEs. The incidence of common TEAEs (affecting ≥ 10% of the study population), including gastrointestinal disorders, nervous system disorders, general disorders and administration site conditions, and skin and subcutaneous tissue disorders, was not changed due to combined administration of acetaminophen and ibuprofen in Maxigesic® IV.
This study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure (≥ 48 hours).
- Conditions
- Postoperative Pain
- Being tested
- Maxigesic® IV
- Keywords
- Analgesic
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxigesic® IVDrug
acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Maxigesic® IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs (Treatment-emergent Adverse Events)
The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV
Measured: During treatment period (≥ 48 hours - 5 days)
Secondary outcomes (29)
Time Course of TEAEs
The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV during various study time periods
Measured: 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.
Incidence of TRAEs (Treatment-related Adverse Events)
The incidence of treatment-related adverse events (TEAEs considered by the investigator to be "probably" or "definitely" related to the study drug) associated with exposure Maxigesic® IV
Measured: During treatment period (≥ 48 hours - 5 days)
Incidence of TEAEs of Interest
The incidence of TEAEs of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events)
Measured: During treatment period (≥ 48 hours - 5 days)
Changes in Blood Pressure
Systolic and Diastolic Blood Pressured Measured every 24 hours
Measured: From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Changes in Heart Rate
Measured every 24 hours
Measured: From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Changes in Temperature
Measured every 24 hours
Measured: From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Changes in Respiratory Rate
Respiratory Rate Measured every 24 hours
Measured: From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Changes in Hematology Values (Hemoglobin)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hematology Values (Hematocrit)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hematology Values (Platelet Count)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hematology Values (Red Blood Cell Count)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hematology Values (White Blood Cell Count)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hematology Values (Differential Leukocyte Count)
Hematology test was Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Sodium)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Potassium)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Urea)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Creatinine)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Phosphate)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Glucose)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Albumin)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Total Protein)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Alkaline Phosphates)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Gamma-glutamyl Transferase)
Blood Biochemistry was Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Aspartate Transaminase)
Blood Chemistry (AST) was Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Alanine Transaminase)
Blood Chemistry (ALT) was Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Bilirubin)
Measured at screening visit and at the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in ECG (Electrocardiography) Status (Normal/Abnormal)
All components of the ECG will be analysed to assess safety (P wave, QRS Complex, QT interval, PR interval, T wave, ST segment, U wave, PR segment) in 5 categories of the shift from baseline to the end of treatment from:
Normal to Normal Normal to Abnormal NCS (Non-clinically Significant) Abnormal NCS to Normal Abnormal NCS to Abnormal NCS Missing
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
The elevation in hepatic enzymes (ALP, ALT, AST, GGT) from baseline to the end of the treatment
Measured: Prior to surgery, on Day 1 and at discharge (Day 5)
Patient's Global Evaluation of the Study Drug
Summary of the patients' ratings of the study medication (1 = Poor; 2 = Fair; 3 = Good; 4 = Very Good; 5 = Excellent)
Measured: 5 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start22 Jul 2019
- Primary completion30 Jun 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- AFT Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ira Gottlieb, DPM, Principal investigator, Chesapeake Research GroupSimon Carson, MD, Principal investigator, Southern Clinical Trials LtdGregory L Ruff, MD, Principal investigator, Chapel Hill Research GroupNigel Gilchrist, MD, Principal investigator, CGM Research Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005755
- Sponsor's protocol ID
- AFT-MXIV-11
- Status last verified
- Apr 2019
- First submitted
- 19 Jun 2019
- Last updated
- 1 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04005755
- Acronym / sponsor ID
- AFT-MXIV-11
- Conditions
- Postoperative Pain
- Keywords
- Analgesic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- AFT Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Posted 1 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure.
Detailed description
Combined administration of acetaminophen and ibuprofen has been shown to provide superior analgesia over administration of comparable doses of either component alone or placebo, when given as an intravenous formulation or as a solid oral tablet in the postoperative setting.
The superior efficacy of the combination does not appear to come at the expense of tolerability. A previous study of Maxigesic® IV in bunionectomy patients found that there were no differences between patients treated with repeated doses of Maxigesic® IV and those treated with intravenous acetaminophen, ibuprofen or placebo in the rate of discontinuations due to adverse events (AEs), the overall incidence of treatment-emergent AEs (TEAEs) or the severity of TEAEs. The incidence of common TEAEs (affecting ≥ 10% of the study population), including gastrointestinal disorders, nervous system disorders, general disorders and administration site conditions, and skin and subcutaneous tissue disorders, was not changed due to combined administration of acetaminophen and ibuprofen in Maxigesic® IV.
This study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure (≥ 48 hours).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maxigesic® IV | Experimental | Drug: Maxigesic® IVAcetaminophen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Maxigesic® IVacetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion | Drug | Maxigesic® IV |
Primary outcome
Incidence of TEAEs (Treatment-emergent Adverse Events)
Time frame: During treatment period (≥ 48 hours - 5 days)
The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV
29 secondary outcomes
Time Course of TEAEs
Time frame: 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.
Incidence of TRAEs (Treatment-related Adverse Events)
Time frame: During treatment period (≥ 48 hours - 5 days)
Incidence of TEAEs of Interest
Time frame: During treatment period (≥ 48 hours - 5 days)
Changes in Blood Pressure
Time frame: From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Changes in Heart Rate
Time frame: From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Changes in Temperature
Time frame: From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Changes in Respiratory Rate
Time frame: From the baseline (Day 1 prior to surgery) until 7 days after the last dose
Changes in Hematology Values (Hemoglobin)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hematology Values (Hematocrit)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hematology Values (Platelet Count)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hematology Values (Red Blood Cell Count)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hematology Values (White Blood Cell Count)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hematology Values (Differential Leukocyte Count)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Sodium)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Potassium)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Urea)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Creatinine)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Phosphate)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Glucose)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Albumin)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Total Protein)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Alkaline Phosphates)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Gamma-glutamyl Transferase)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Aspartate Transaminase)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Alanine Transaminase)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Blood Biochemistry Values (Bilirubin)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in ECG (Electrocardiography) Status (Normal/Abnormal)
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Time frame: Prior to surgery, on Day 1 and at discharge (Day 5)
Patient's Global Evaluation of the Study Drug
Time frame: 5 days after the first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Ira Gottlieb, DPM principal investigator
Chesapeake Research Group
Simon Carson, MD principal investigator
Southern Clinical Trials Ltd
Gregory L Ruff, MD principal investigator
Chapel Hill Research Group
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maxigesic® IV in people with Postoperative Pain, run by AFT Pharmaceuticals, Ltd. at 4 sites in 2 countries.
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 10 inclusion and 16 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: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, New Zealand. 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?
Yes. Results are posted in the registry (first posted 1 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs (Treatment-emergent Adverse Events) (time frame: During treatment period (≥ 48 hours - 5 days)). 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 Sep 2021.