2024-513595-17-00已完成2 期
Efficacy and tolerability of ODM-111 in chronic pain due to diabetic peripheral neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 34
- 主要终点
- The primary efficacy endpoint is the change from baseline to week 6 in the weekly average of daily pain intensity (average over the previous 24 hours) on the 11-point numeric rating scale (NRS), as reported in the daily eDiary.
研究概览
简要总结
To evaluate the efficacy of ODM-111 in the treatment of chronic pain due to diabetic peripheral neuropathy (DPN).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent (IC) for participation in the trial.
- •Males and females 18 to 80 years of age at screening visit
- •Body mass index (BMI) 18-45 kg/m2 at screening visit.
- •Type 1 or Type 2 diabetes of at least 6 months duration with optimised and stable glycaemic control during the 3 months prior to screening.
- •A diagnosis of painful diabetic peripheral neuropathy (DPN) with pain for at least 6 months before the screening visit that is primarily in the lower extremities.
- •An average pain intensity of ≥[blinded information] on the 11-point (0-10) numerical rating scale (NRS) in the lower extremities during the past 24 h at screening and at baseline.
- •A weekly average of daily pain intensity on the 11-point (0-10) numerical rating scale (NRS) at baseline, based on daily assessments over at least 5 of the 7 consecutive days preceding the baseline visit.
- •Douleur Neuropathique 4 (DN4) score of ≥[blinded information] at the screening visit.
- •Female participants with fertile male partners and male participants with female partners of child-bearing potential must adhere to a highly effective form of contraception (e.g. combined or progestogen only hormonal contraceptives associated with inhibition of ovulation, intrauterine devices or intrauterine hormone-releasing system) if sexually active and not permanently sterilised, for females from 4 weeks before the first study treatment administration and for males from Day 1 until 3 months after the EOS visit. Additionally, women who are postmenopausal (1 year since last menstrual cycle) are considered not to be reproductive and can be included. For male participants, sperm donation is not allowed until 3 months after the EOS visit.
排除标准
- •A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions or to communicate well with the investigator.
- •Active infection.
- •Females who are pregnant or lactating at screening or planning to become pregnant within 1 month from the last dose of study treatment.
- •HbA1c >10% or >86 mmol/mol at screening.
- •Peripheral neuropathy caused by a condition other than diabetes mellitus.
- •Concomitant pain conditions (i.e., low back pain, radiculopathy, bone, and musculoskeletal disorders) which may impair self-assessment of pain due to diabetic peripheral neuropathy.
- •Use of analgesic treatment during the trial (from at least 10 days before the baseline visit until the last treatment visit), excluding the following: a. Gabapentin (up to 1800 mg daily), pregabalin (up to 300 mg daily), or duloxetine (up to 60 mg daily); only one of these preparations per participant is allowed and the dose must have been stable for ≥3 months prior to trial entry and will be kept stable for the study treatment period b. Acetylsalicylic acid for cardiovascular reasons, stable dosing up to 325 mg daily c. Paracetamol as rescue analgesia, up to 3 g daily as needed.
- •Chronic inflammatory disease
- •Diagnosis of long COVID (including self-diagnosis by participant
- •Known hypersensitivity to the active substance or to any of the excipients of the study treatment.
结局指标
主要结局
The primary efficacy endpoint is the change from baseline to week 6 in the weekly average of daily pain intensity (average over the previous 24 hours) on the 11-point numeric rating scale (NRS), as reported in the daily eDiary.
The primary efficacy endpoint is the change from baseline to week 6 in the weekly average of daily pain intensity (average over the previous 24 hours) on the 11-point numeric rating scale (NRS), as reported in the daily eDiary.
次要结局
未报告次要终点
研究者
Clinical Study Director
Scientific
Orion Corporation
研究点 (34)
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