EUCTR2011-005879-16-GB进行中（未招募）不适用
A Phase II, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Neuropathy
Glenmark Pharmaceuticals SA0 个研究点目标入组 55 人开始时间: 2012年3月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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) Patients willing to provide voluntary written informed consent
- •2) Male and female (women of non child-bearing potential) patients =18 yrs and = 75 yrs
- •3) Patients with diabetes mellitus (type 1 or 2) with distal symmetric chronic sensorimotor painful peripheral neuropathy
- •4) A history of pain for at least 6 months and no greater than 5 years attributed to DPN (Note this requirement refers to duration of pain, not the duration of DPN).
- •5) DN4 (Douleur Neuropathique en 4 questions) score of =4
- •6) A baseline 24-hour average daily pain intensity score =5 as measured on a 11 point pain intensity NRS. The baseline score is the calculated mean of the 24-hour daily average pain scores during the 7 days prior to randomization. The patient must record at least 4 assessments of the 24-hour daily average pain intensity score during the seven-day placebo run-in period in the patient diary.
- •7) Pain uncontrolled with up to 2 medications for the treatment of pain associated with DPN. The patient’s medical history may indicate that the pain was not controlled with:
- •a) 1 medication for painful DPN or
- •b) 2 medications for painful DPN taken over different time-periods in the past or
- •c) 2 medications for painful DPN taken over the same time-periods in the past (ie combination therapy using 2 drugs)
- •8) Patients willing to withdraw their neuropathy medications for the whole duration of study starting from washout period till end of study visit.
- •9) Stable glycaemic control for three months prior to randomization (diabetic regimens may be changed after randomization to maintain glycaemic control) as defined by:
- •a) Insulin: <25% change of their current insulin dose to maintain glycaemic control
- •b) Oral antidiabetic agents: <50% change of their current oral dose to maintain glycaemic control.
- •c) Addition of 1 oral hypoglycaemic agent at its therapeutic dose to the existing treatment regimen.
- •10) Patients detected to have mechanical hyperalgesia and/or cold allodynia on the basis of appropriate methodology: The study will intend to randomize at least 5 patients with either mechanical hyperalgesia and/or cold allodynia into each of the 3 treatment arms (90 mg, 250/30 mg and placebo).
- •11) HbA1c level <11
- •12) Women must be of non child-bearing potential, defined as post menopausal or surgically sterile.
- •Menopause is defined as:
- •12 months of spontaneous amenorrhea or
- •6 months of spontaneous amenorrhea with a serum follicular stimulating hormone (FSH) level >40 mIU/L
- •Surgically sterile: Females who have a documented hysterectomy and/or bilateral oophorectomy at least 6 weeks before screening. Tubal ligation does not constitute non-child bearing potential.
- •13) It is required that all male patients with partners of child-bearing capacity use the following methods of contraception from the first dose of study medication and until 90 days after the last dose as shown below:
- •All sexually active males must use a condom in addition to one of the following conditions:
- •1) Male patients must have had a vasectomy for more than 6 months
- •2) Female partner who meets one of the following conditions:
- •has had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy;
- •is post-menopausal;
- •uses one of the following forms of contraception:
- •1. consistent use of oral, injected or implanted hormonal methods of contraception
- •2. Placement of intra-uterine device (IUD) or intra-uterine system (IUS)
- •3. Barrier methods only wh
排除标准
- •1) Patients with a 24-hour daily average pain intensity of = 9 on the 11-point NRS at visit 1 or visit 3
- •2) Other chronic pain conditions not associated with DPN that may confound the assessment of neuropathic pain. However, the patient will not be excluded if:
- •a)The pain condition is located at a different region of the body (other than lower limbs), and
- •b) The pain intensity of this condition is not greater than the pain intensity of DPN, and
- •c) The patient can assess pain due to DPN independently of their other pain condition.
- •3) Other causes of neuropathy or lower extremity pain which may include, but not be limited to:
- •a) Lower extremity pain of any severity caused by: osteoarthritis of the ankle or foot, gout, bursitis, or fasciitis.
- •b) Past medical history or known current medical condition of diffuse peripheral neuropathy caused by alcoholism, malignancy, human immunodeficiency virus (HIV), syphilis, drug abuse, peripheral ischaemia, Vitamin B 12 deficiency, hypothyroidism, liver disease, chemotherapy or radiation therapy.
- •c) Focal neuropathy in the lower extremities including nerve entrapment or local trauma.
- •d) Acute or chronic inflammatory polyradiculopathy.
- •e) Multiple sclerosis or other conditions associated with central neuropathic pain.
- •f) Pain associated with distal limb ischaemia including intermittent claudication.
- •4) Complex regional pain syndrome or trigeminal neuralgia
- •5) Use of the following drugs within 7 days prior to start with the baseline pain intensity assessment ( i.e, 7 days prior to visit 2)
- •a) Antidepressants, anticonvulsants or mexiletine
- •b) Opioids or morphinomimetics
- •c) Fatty acid supplements, primrose oil, myoinositol, chromium picolinate that are known to be used in neuropathic pain
- •d) Acetyl salicylic acid (ASA) except up to 325 mg/d post myocardial infarction or prevention, transient ischaemic attack prophylaxis
- •e) Benzodiazepines other than indicated at low doses for sleep disorders
- •f) Lidocaine patch
- •g) Non-drug therapies or procedures (i.e. nerve blocks, trans cutaneous electrical nerve stimulation [TENS]) for the relief of pain of DPN for the required run in period and throughout the duration of the study.
- •h) Herbal medication/supplements, St Johns wort and grape fruit juice (more than 1 quart/day)
- •6) Capsaicin use within last 03 months of screening
- •7) Diabetic foot ulcer of = 3 months duration. Diabetic foot ulcer of > 3months can be included in the study only if the ulcer has been stable for a period of at least 3 months prior to screening.
- •8) Lower extremity amputations other than toes
- •9) Has any of the following laboratory abnormalities, medical conditions or disorders:
- •a) Alanine aminotransferase (ALT) > 1.5x upper limit of normal (ULN) or direct bilirubin > 1.5x ULN.
- •b) Chronic hepatitis B or C with a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C Core Antigen Antibody (Hep C antibody).
- •c) Serum creatinine >150 µmol/L
- •d) Corrected QT (QTc) interval using Bazett’s correction >430 msec in males >450msec in females based on single or average QTc value of triplicate electrocardiograms (ECGs) obtained over a brief recording period.
- •e) Uncontrolled hypertension at screening (sitting systolic blood pressure [SBP] >160 mmHg and/or sitting diastolic blood pressure [DBP] >90 mmHg.
- •f) Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drug(s).
- •g) Patients with clinically si
研究者
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