EUCTR2016-002611-18-DE进行中（未招募）1 期
An exploratory, randomized, double-blind, double-dummy, placebo- and active-controlled Phase II trial to evaluate the efficacy and safety of a topical application of GRT7019 in subjects with chronic pain due to knee osteoarthritis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject has given written informed consent to participate.
- •2. Male or female subject aged 40 years to 80 years, inclusive, at the Enrollment Visit (Day -14 to Day -7).
- •3. Body mass index (BMI) between 20 kg/m2 and 36 kg/m2 inclusive, with a minimal body weight of 55 kg at the Enrollment Visit.
- •4. Diagnosis of OA of the index knee (the one under investigation) based on American College of Rheumatology (ACR) criteria and functional capacity class of I-III and pain must be present for at least 3 months before the Enrollment Visit according to prior/concomitant diseases and surgical interventions.
- •5. Use of medically acceptable methods of contraception and willingness to use them during the trial if the subject or the partner of the subject is a woman of childbearing potential.
- •6. Subject must be on stable analgesic medications for their condition with regular intake for at
- •least 3 months prior to the Enrollment Visit according to their prior/concomitant diseases and
- •surgical interventions.
- •7. No intake of rescue medication during the last 3 days prior to the Baseline Visit (Day 1) (to be checked at the Baseline Visit).
- •8. A baseline average pain intensity of equal to or above 4 and below 8 on the NRS at the Baseline Visit on Day 1 (as calculated by the electronic diary [eDiary]).
- •9. Subject completed at least 5 out of 6 possible morning and evening pain intensity assessments during the last 3 days prior to the Baseline Visit and including the morning of the Baseline Visit (as calculated by the eDiary).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 175
排除标准
- •1. Concurrent participation in another trial, or within 30 days before the Enrollment Visit of this trial. Depending on the nature of the previous investigational medicinal product (IMP), a longer washout may be needed.
- •2. Evidence or history of alcohol or drug abuse including positive or missing drugs of abuse test at the Enrollment Visit.
- •3. Woman of childbearing potential with a positive or missing urine ß-human chorionic gonadotropin (ß-hCG) pregnancy test at the Enrollment Visit.
- •4. Past or pending litigation due to chronic pain or disability.
- •5. Employees of the investigator, trial site, or sponsor, with direct involvement in the proposed trial or other trials under the direction of that investigator, trial site, or sponsor, as well as family members of employee or the investigator.
- •6. Any clinically significant disease that in the investigator’s opinion may affect efficacy or safety assessments or may compromise the subject’s safety during trial participation, e.g., non-stabilized hypertension, significant pulmonary, gastrointestinal (GI), endocrine, metabolic, neurological, or psychiatric disorders.
- •7. History or presence of malignancy, with the exception of curative treated subject or subject being in remission of cancer for at least 2 years before enrollment and not requiring treatment.
- •8. Surgery of any joint within 3 months of the Enrollment Visit or any scheduled surgery or painful procedure during the course of the trial.
- •9. Clinically relevant history of hypersensitivity, allergy, or contraindications to any of the IMPs’ drug substances and excipients, or to pantoprazole or paracetamol.
- •10. Known hypersensitivity or allergy to lidocaine, other amide anesthetics, or diclofenac.
- •11. Conditions that require treatment with forbidden medication.
- •12. Painful conditions other than due to OA that contribute relevantly to pain and confound the assessment of self-evaluation of pain, for instance psoriatic arthritis, gout, low back pain, or significant skin conditions such as abscesses.
- •13. Known or suspected inability to comply with the requirements of the trial protocol or the instructions of the trial site staff.
- •14. Intake of opioids or cannabinoids in the last 3 months before the Enrollment Visit.
- •15. Known reactions of bronchospasm, asthma, rhinitis, or urticarial after the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) in the past.
- •16. Hematopoietic disorder of unclear genesis.
- •17. Persisting or repeatedly occurred peptic ulcers or hemorrhage in the past (at least 2 distinct confirmed episodes of ulceration or bleeding).
- •18. Gastrointestinal bleeding or perforation in anamnesis in conjunction with previous therapy with NSAIDs.
- •19. Cerebrovascular or other active bleeding.
- •20. Severe dysfunction of the liver or kidney.
- •21. Known heart insufficiency (New York Heart Association [NYHA] Class II-IV), ischemia of the heart, peripheral artery occlusive disease, and/or cerebrovascular disease.
- •22. Skin injuries or open wounds at the site of planned patch application.
研究者
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