EUCTR2012-002320-33-DE进行中（未招募）不适用
A Phase 2, 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 Peripheral Neuropathy
Glenmark Pharmaceuticals SA0 个研究点目标入组 138 人开始时间: 2012年7月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 138
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 (post menopausal/surgically sterile only) 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 and < 9 as measured on an 11 point pain intensity NRS. The baseline score is the calculated as mean of the 24-hour daily average pain scores during the 7 days prior to randomisation. The patient must record at least 4 assessments of the 24-hour daily average pain intensity score during the 7-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 entire duration of study starting from washout period till end of study visit. Discontinuation of ongoing diabetic neuropathy pain medications during the study (from wash-out period to visit 8) must be medically justifiable and appropriate (eg, inadequate pain control, AEs, contra indication etc). Patients who are stable on the ongoing pain medications and have no medical justification to withdraw these medications will not be included in the study.
- •9) Stable glycaemic control for three months prior to randomisation (for subjects with HbA1c < 8%) as defined by:
- •a) Insulin: <25% change of their mean 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 up to 1 oral hypoglycaemic agent at its therapeutic dose to the existing treatment regimen.
- •Patients with HbA1c of 8 to 11% are eligible if attempts to improve diabetic control with optimal treatment with authorized drugs have failed.
- •Diabetic regimens may be changed after randomisation to maintain glycaemic control. Patients will receive guideline-based diabetes control that is individually adapted to their comorbidity and risk profile.
- •10) Patients detected to have mechanical hyperalgesia and/or cold allodynia on the basis of appropriate methodology: The study will intend to randomise at least 38 patients with either mechanical hyperalgesia and/or cold allodynia out of the total 138 planned patients.
- •11) Women must be of non child-bearing potential, defined as post menopausal or surgically sterile.
- •Menopause is defined as 12 months of spontaneous amenorrhea with a serum follicular stimulating hormone (FSH) level >40 mIU/L
- •Surgically sterile women: defined as 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.
- •12) It is required that all male patients use the following methods of contraception from the first dose of study medication and until 90 days after the last dose as shown below:
排除标准
- •Patients meeting any of the following criteria must not be enrolled in the study:
- •1) 24-hour daily average pain intensity of = 9 on the 11-point NRS at
- •visits 1 or 3
- •2) Other chronic pain conditions not associated with DPN that may
- •confound the assessment of neuropathic pain. Patients will not be
- •excluded if:
- •a) pain condition is located at a different region of the body (other than
- •lower limbs), and
- •b) pain intensity of this condition is not greater than the pain intensity of
- •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) diffuse peripheral neuropathy caused by alcoholism, malignancy,
- •human immunodeficiency virus (HIV), syphilis, drug abuse, peripheral
- •ischaemia, Vitamin B 12 deficiency, abnormal folate, 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 within 7 days prior to start with the baseline pain
- •intensity assessment
- •a) Antidepressants, anticonvulsants or mexiletine (exceptions: fluvoxamine, norfluoxetine, nefazodone, carbamazepine, barbiturates, phenytoin and oxcarbazepine-patients on these medications at screening will be excluded)
- •b) Opioids or morphinomimetics
- •c) Fatty acid supplements, primrose oil, myoinositol, chromium picolinate, alpha-lipoic acid, benfotiamine, actovegin that are known to be used in neuropathic pain
- •d) Acetyl salicylic acid except up to 325 mg/day for myocardial infarction or 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]).
- •6) Use of herbal medication/supplements, St Johns wort and grape-fruit juice (more than 0.9 L/day) within 3 weeks prior to visit 2
- •7) Capsaicin use within 3 months of screening
- •8) Diabetic foot ulcer of = 3 months duration
- •9) Lower extremity amputation other than toes
- •10) 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 or
- •Hepatitis C Core Antigen 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
- •e) Uncontrolled hypertension at screening (sitting SBP >160 mmHg
- 另有 4 项未显示
研究者
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