[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AFT Pharmaceuticals, Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100626513","phase-2-rapamycin-dose-ranging-efficacy-study-in-port-wine-stains-100626513",false,"NCT07436611","Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains","Rapamycin Dose-Ranging Efficacy Study: A Phase II, Proof of Concept, Double-blind, Placebo-controlled, Randomized, Parallel-group, Dose-response Comparison of the Effects of Different Strengths of Rapamycin Cream Applied Topically in Subjects Diagnosed With Port Wine Stains","Inclusion Criteria:\n\n1. Male and female patients aged ≤ 10 years on the day informed consent is obtained\n2. Patients presenting either facial, neck, or upper trunk port-wine stains\n3. Port wine stain size of at least 5 cm tall x 2.5 cm wide (2x1 inches)\n4. Patients (or their legal representatives) capable of understanding the explanation of the clinical trial, and who give written informed consent for participation\n5. Patients (or their legal representatives) able to maintain patient diaries following the instructions of the investigator or sub-investigator\n6. Patients (or their guardians) are willing and able to follow instructions to only apply cream to part of their port-wine stain\n7. Skin type classified as either I, II, III or IV on the Fitzpatrick scale\n8. Patients who are indicated for PDL treatment and accept this treatment\n9. Patients who respond to PDL with purpura or blanching\n\nExclusion Criteria:\n\n1. Skin type classified as either V or VI on the Fitzpatrick scale\n2. Patients with PWS in extremities and\u002For acral areas\n3. Patients unwilling or unable to carry out the treatment plan or follow-up assessment\n4. Patients with serious skin lesions such as erosions or ulcers\n5. Patients with known hypersensitivity to any component of the study product\n6. Patients who have received rapamycin\u002Fsirolimus, everolimus, or temsirolimus within 3 months of enrolment\n7. Patients who have received laser therapy or surgical therapy to treat PWS within 3 months prior to trial enrolment\n8. Patients who have received 5 or more PDL treatments previously\n9. Patients who participated in any other clinical trial within 3 months prior to the day of enrolment\n10. Patients judged unsuitable for this clinical trial by the investigator or sub-investigator\n11. Pregnant or lactating females\n12. Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception\\*\n13. Patients with immune dysfunction or receiving any form of immunosuppression","ALL","10 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn if the use of rapamycin cream can be used as a treatment together with pulsed dyed laser in treating port wine stain birthmarks. The main question it aims to answer is:\n\nWill rapamycin cream and laser treatment show a greater improvement in appearance of port wine birthmarks, compared to treatment with placebo cream and laser?\n\nResearchers will compare two concentrations of rapamycin cream (0.6% or 1.0%) with placebo treatment to see if appearance is improved following 12 weeks of treatment.\n\nParticipants will receive laser treatment of their port wine birthmark and then apply the rapamycin or placebo cream daily for 12 weeks. Patients will visit the clinic every 4 weeks for checkups and tests.",[26],"Port Wine Stains",[28,29,30,31,32,33],"sirolimus","rapamycin","adjunct therapy","proof of concept","phase 2","dose ranging","NOT_YET_RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":20},"2026-08",{"date":42,"type":20},"2027-10",{"name":44,"class":45},"AFT Pharmaceuticals, Ltd.","INDUSTRY",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100610288","phase-3-a-study-of-combogesic-iv-intravenous-in-pediatric-patients-with-acute-pain-100610288","NCT07225634","A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain","An Open Label, Pharmacokinetic and Safety Study of Combogesic® IV in Pediatric Patients With Acute Pain","Inclusion Criteria:\n\n1. Is male or female aged between 2 and \\\u003C17 years.\n2. 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.\n3. Is either able to provide written informed consent or consent is provided from parents\u002Flegal guardians and assent provided from participants (where appropriate).\n4. 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.\n5. Have negative HIV and hepatitis B \\& C test results.\n\n   * Acute pain indications may include but are not limited to post-operative pain associated with musculoskeletal or soft tissue surgery, fractures or injury, or medical procedures.\n\nExclusion Criteria:\n\n1. 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.\n2. 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.\n3. 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.\n4. 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.\n5. 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.\n6. 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.\n7. Is considered by the Investigator, for any reason to be an unsuitable candidate to receive the study drug.\n8. 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).\n9. Is currently receiving anticoagulants (e.g. heparin or warfarin).\n10. Has received a course of systemic corticosteroids (either oral or parenteral) within 3 months before screening (inhaled nasal steroids and regional\u002Flimited area application of topical corticosteroids (Investigator discretion) are allowed).\n11. Has a history of chronic use (defined as daily use for \\> 2 weeks) of NSAIDs, opiates, or glucocorticoids (except inhaled nasal steroids and regional\u002Flimited 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.\n12. 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).\n13. Has any clinically significant laboratory finding at screening that, in the opinion of the Investigator, contraindicates study participation.\n14. Participated in another clinical study within 30 days before Screening.\n15. Pregnant or lactating females\n16. Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception","2 Years","16 Years",{"count":57,"type":20},60,[59],"PHASE3","Combogesic® IV is an intravenous medicine (given by vein) containing a combination of two pain relief (analgesic) medicines called ibuprofen and acetaminophen. The goal of this clinical trial is to study the way that the body processes and clears the intravenous infusion of Combogesic® IV and that it is safe to be used in children and adolescents between the ages of 2 and \\\u003C17 years.\n\nWhat will the study involve for participants?\n\n* Combogesic® IV will be administered every 6 hours as necessary with a maximum of 4 doses within a 24-hour period as an intravenous infusion for about 15 minutes.\n* Participants will receive Combogesic® IV for a minimum of 12 hours (2 doses) up to a maximum of 5 days (20 doses). Dosing will be dependent on body weight.\n* If pain is not sufficiently controlled by Combogesic® IV, opioids may be used as supplementary pain relief at the discretion of the study doctor.\n* Have their blood samples collected before dosing and at specific times after dosing. The amount of study drug in the blood will be measured, and safety assessments (including blood and urine samples) will be done.\n* Rate the study drug at the end of the treatment.\n\nIt is expected that Combogesic® IV will be well tolerated in children and adolescents and that the pharmacokinetics findings will be similar as compared with adults.",[62],"Acute Pain",{"date":37,"type":38},{"date":65,"type":20},"2026-09",{"date":67,"type":20},"2027-04",{"name":44,"class":45},1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":89,"locationsCount":69},"100610250","phase-3-a-study-of-combogesic-325-in-adolescent-patients-with-moderate-to-severe-postoperative-pain-associated-with-orthopedic-surgery-100610250","NCT07225140","A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery","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","Inclusion Criteria:\n\n* Provide written informed consent or consent be provided from parents\u002Flegal guardians and assent from participants (where appropriate).\n* 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.\n* Be undergoing planned orthopedic surgery which requires at least 24 hours of hospital inpatient stay.\n* 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.\n* 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.\n* Have negative HIV and hepatitis B \\& C test results.\n\nExclusion Criteria:\n\n* Has taken any NSAID or acetaminophen containing drug products within 5 half-lives prior to the initial dose of study drug.\n* Hypersensitivity to opioids, NSAIDs or acetaminophen or a history of severe\u002Fserious drug reaction to NSAIDs or acetaminophen.\n* Pregnant or lactating females Known to be pregnant or possibly pregnant.\n* Sexually active females of childbearing potential not using adequate contraception\\* and sexually active males not using adequate contraception\\*\\*\n* 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.\n* Women of childbearing potential who are unwilling to undergo a urine pregnancy test.\n* 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.\n* In the opinion of the Investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.\n* Currently or in last 30 days, has been in a clinical trial involving another study drug.\n* Have donated blood or blood products within 30 days prior to study drug administration\n* Advanced renal impairment (serum creatinine \\>132 µmol\u002FL) or a risk for renal failure due to volume depletion.\n* 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.\n* 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).\n* History of severe asthma in the opinion of the investigator.\n* Has a history of drug or alcohol abuse\n* 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.\n\n  * Methods of contraception that are deemed adequate have failure rates of \\\u003C 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.","12 Years","17 Years",{"count":80,"type":20},180,[59],"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 \\\u003C18 years.\n\nWhat will the study involve for participants?\n\n* Participants will be randomly allocated to one of 3 treatment groups:\n\n  * 3 tablets of Combogesic® 325,\n  * 2 tablets of Combogesic® 325 and 1 tablet of placebo or\n  * 2 tablets of acetaminophen1000mg and 1 tablet of placebo\n* Participants will take 3 tablets every 6 hours with a maximum of 4 doses in 24 hours\n* Participants and study doctor will be blinded to the treatment group\n* If pain is not sufficiently controlled, opioids may be used as supplementary pain relief at the discretion of the study doctor.\n* Participants will complete a patient diary to assess their pain\n* Participants will rate the study drug at the end of the treatment.\n\nIt 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.",[84],"Post Operative Pain, Acute",{"date":37,"type":38},{"date":87,"type":20},"2026-10",{"date":42,"type":20},{"name":44,"class":45},""]