EUCTR2011-005879-16-DE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1月27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.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, adverse events, 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 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.
- •Diabetic regimens may be changed after randomization to maintain glycaemic control. Patients will receive guideline-based diabetes control that is individually adapted to their comorbidity and risk profile.
- •Patients with HbA1c of 8 to 11% are eligible if attempts to improve diabetic control with optimal treatment with authorized drugs have failed.
- •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) 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.
- •12) It is required that all male patients with partners of child-bear
排除标准
- •1)Patients with 24-hour daily average pain intensity = 9 on 11-point NRS
- •at visit 1 or 3
- •2)Other chronic pain conditions. However, the patient will not be
- •excluded if:
- •a)The pain is at a different region of the body (other than lower limbs),
- •b)The pain intensity of this condition is not greater than the pain
- •intensity of DPN, and
- •c)They can assess pain due to DPN independently of their other pain
- •3)Other causes of neuropathy or lower extremity pain including but not
- •limited to:
- •a)Osteoarthritis of the ankle or foot, gout, bursitis, or fasciitis.
- •b)Medical history or known current medical condition of diffuse
- •peripheral neuropathy caused by alcoholism, malignancy, HIV, syphilis,
- •drug abuse, peripheral ischaemia, Vitamin B 12 deficiency,
- •hypothyroidism, liver disease, chemotherapy or radiation therapy.
- •c)Focal neuropathy in 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 of the baseline pain intensity
- •a)Antidepressants, anticonvulsants or mexiletine
- •b)Opioids or morphinomimetics
- •c)Fatty acid supplements, primrose oil, myoinositol, chromium picolinate
- •d)Acetyl salicylic acid except up to 325 mg/d post myocardial infarction
- •or prevention, transient ischaemic attack prophylaxis
- •e)Benzodiazepines other than at low doses for sleep disorders
- •f)Lidocaine patch
- •g)Non-drug therapies or procedures for the relief of pain for the 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 3 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)Any of the following lab abnormalities, medical conditions or
- •a)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 >430 msec in males >450msec in females
- •e)Uncontrolled hypertension at screening (sitting systolic blood pressure
- •>160 mmHg and/or sitting diastolic blood pressure >90 mmHg.
- •f)Current diagnosis of active epilepsy or any active seizure disorderrequiring chronic antiepileptic therapy
- •g)Clinically significant or uncontrolled hepatic, GI, cardiovascular,
- 另有 12 项未显示
研究者
相似试验
进行中（未招募）
不适用
A 4 week study to evaluate the effectiveness and safety of GRC 17536 a new medication in patients with diabetes who have nerve involvementEUCTR2011-005879-16-GBGlenmark Pharmaceuticals SA55
已完成
2 期
A clinical trial to study the effects of GRC 17536 in patients with painful diabetic peripheral neuropathy (painful extremities due to peripheral nerve damage in diabetic patients).CTRI/2013/02/003347Glenmark Pharmaceuticals SA138
进行中（未招募）
1 期
A 4 week study to evaluate the effectiveness and safety of GRC 17536 a new medication in patients with diabetes who have peripheral nerve involvementPain associated with diabetic peripheral neuropathy (DPN).MedDRA version: 20.0 Level: LLT Classification code 10012683 Term: Diabetic peripheral neuropathy System Organ Class: 100000004852EUCTR2012-002320-33-GBGlenmark Pharmaceuticals SA138
进行中（未招募）
不适用
A 4 week study to evaluate the effectiveness and safety of GRC 17536 a new medication in patients with diabetes who have peripheral nerve involvementPain associated with diabetic peripheral neuropathy (DPN).MedDRA version: 14.1Level: LLTClassification code 10012683Term: Diabetic peripheral neuropathySystem Organ Class: 10029205 - Nervous system disordersEUCTR2012-002320-33-DEGlenmark Pharmaceuticals SA138
进行中（未招募）
不适用
A 4 week study to evaluate the effectiveness and safety of GRC 17536 a new medication in patients with diabetes who have peripheral nerve involvementEUCTR2012-002320-33-CZGlenmark Pharmaceuticals SA138