[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grünenthal GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100655066","phase-2-a-clinical-trial-of-grt7040-in-adults-with-acute-pain-following-bunionectomy-100655066",false,"NCT07807644","A Clinical Trial of GRT7040 in Adults With Acute Pain Following Bunionectomy","A Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, 2-Part Phase 2 Trial to Investigate the Efficacy and Safety of GRT7040 in Adult Participants With Acute Pain Following Bunionectomy","Inclusion Criteria\n\n* Adults scheduled for a primary unilateral bunionectomy with distal first metatarsal osteotomy and internal fixation under regional anesthesia.\n* Able and willing to provide informed consent and comply with study procedures.\n* Body weight ≥50 kg and BMI 18 to 40 kg\u002Fm².\n* Medically fit for surgery and study treatment based on medical history, physical examination, ECG, vital signs, and laboratory assessments.\n* Meets protocol-specified contraception requirements.\n* After surgery, reports moderate to severe pain (Verbal Rating Scale) with a Numeric Pain Rating Scale (NPRS) score ≥4 within 9 hours after removal of the popliteal sciatic block.\n* Able to follow commands and has complied with protocol-required perioperative analgesic guidelines.\n\nExclusion Criteria\n\n* Clinically significant medical conditions or laboratory abnormalities that could increase risk or interfere with study assessments.\n* Major surgery within 6 months prior to screening or anticipated need for major surgery during the study.\n* Prior bunionectomy or related surgery on either applicable foot.\n* Peripheral neuropathy affecting the legs.\n* Clinically significant cardiac disease, arrhythmias, QT prolongation risk, or abnormal ECG findings.\n* Sleep apnea requiring positive airway pressure therapy.\n* American Society of Anesthesiologists (ASA) physical status classification ≥3.\n* Contraindication, intolerance, allergy, or unwillingness to receive study-related analgesics, NSAIDs, acetaminophen\u002Fhydrocodone, local anesthetics, or study drug components.\n* Participation in another interventional clinical trial within the protocol-defined exclusion period.\n* Significant renal impairment, hepatic impairment, positive HIV, hepatitis B, or hepatitis C tests.\n* History of substance abuse or addiction within the previous 3 years or positive drug\u002Falcohol screening as specified by the protocol.\n* Blood or plasma donation exceeding protocol limits before screening.\n* Pregnant, breastfeeding, planning pregnancy during the study, or unwilling to comply with contraception requirements.\n* Postoperative factors precluding randomization, including unsuccessful popliteal block placement, surgical complications, non-adherence to postoperative analgesic requirements, or medical complications during surgery.","ALL","18 Years","65 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2 clinical trial of GRT7040, currently being developed for the treatment of moderate-to-severe acute pain. The primary purpose of this trial is to assess efficacy and safety of GRT7040 compared with placebo in adult participants with acute pain following bunionectomy.\n\nThe trial will compare three different doses of GRT7040 given from Day 1 until Day 3 (eg, 48 h after the first investigational medicinal product \\[IMP\\] administration) of GRT7040 or placebo.",[27,28],"Acute Pain","Bunionectomy","NOT_YET_RECRUITING","2026-09-10",{"date":32,"type":33},"2026-09-15","ACTUAL",{"date":35,"type":21},"2026-09",{"date":37,"type":21},"2027-09",{"name":39,"class":40},"Grünenthal GmbH","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100615220","phase-1-a-first-in-human-trial-of-grt7041-in-healthy-participants-100615220","NCT07289776","A First-in-human Trial of GRT7041 in Healthy Participants","A Randomized, Single-center, Double-blind, Placebo-controlled, First-in-human Trial With Single and Multiple Ascending Doses to Determine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GRT7041 in Healthy Participants.","Main Inclusion Criteria:\n\n1. The participant must be able to give signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n2. Participants must sign the ICF before any trial-related assessments.\n3. The participant is in good health as judged by the Investigator including medical history, physical examination, 12-lead ECG, vital signs (pulse rate, respiratory rate, systolic and diastolic BP), body temperature, and clinical laboratory parameters (clinical chemistry, hematology, coagulation and urinalysis) without clinically relevant deviations from reference ranges, unless further specified in the exclusion criteria.\n\nMain Exclusion Criteria:\n\n1. History of any of the following: cardiac impairment, renal impairment, pancreatitis, coagulation abnormalities.\n2. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk for treatment complications\u002F participation in the trial unsafe.\n3. Any disease or conditions known to interfere with the absorption, distribution, metabolism, or excretion of the IMP.\n4. Evidence or medical history of clinically significant and relevant psychiatric issues as assessed by the Investigator.\n5. Confirmed or suspected history of clinically relevant drug allergy.\n6. Major surgical procedure, within 30 days prior to ICF signing, or anticipation of need for a major surgical procedure during the trial.\n7. Blood loss of 500 mL or more (eg, owing to blood donation) within 90 days before Screening Visit.\n8. The participant has used any medication, including herbal remedies or over-the-counter medication within 2 weeks (or 5 half-lives, whichever is longer) before the start of the trial intervention or anticipated use during the trial, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the trial.\n9. The participant is enrolled in another clinical trial unless it is an observational (non-interventional) clinical trial or during the follow-up period of an interventional trial) or has received an IMP in another clinical trial within 30 days before Day 1 or within 5 times the elimination half-life of the IMP, whichever is longer.\n10. Reluctance to comply with contraception requirements.\n11. Evidence or history of alcohol or drug abuse including positive or missing alcohol breath test or drugs of abuse test(s).",true,"60 Years",{"count":51,"type":21},70,[53],"PHASE1","The purpose of this trial is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GRT7041 in healthy male and female (Women of non-childbearing potential) participants.\n\nThe trial duration will be up to approximately 6 weeks for participants in Part 1 (Single ascending dose \\[SAD\\]), except for participants taking part in the food effect cohort SAD3 where the trial duration will be up to approximately 8 weeks. The trial duration will be up to approximately 7 weeks in Part 2 (Multiple ascending dose \\[MAD\\]), and the Treatment Period will be up to 14 days (for Part 2).\n\nThe trial will include a Screening Visit, an in-house stay period and Follow-up (FU) Visit\u002FEnd-of-Trial (EoT) Visit.",[56],"Treatment of Pain","RECRUITING","2026-02-18",{"date":60,"type":33},"2026-02-20",{"date":62,"type":33},"2026-01-14",{"date":64,"type":21},"2026-08-28",{"name":39,"class":40},1,""]