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).
- Conditions
- Health Condition 1: null- Painful Diabetic Peripheral Neuropathy
- Registration Number
- CTRI/2013/02/003347
- Lead Sponsor
- Glenmark Pharmaceuticals SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 138
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 with painful peripheral neuropathy for at least 6 months
4.A baseline 24-hour average daily pain intensity score >=5
5.Women must be of non child-bearing potential, defined as post menopausal or surgically sterile
1.Other chronic pain conditions not associated with DPN, that may confound the assessment of neuropathic pain
2.Other causes of neuropathy or lower extremity pain
3.Complex regional pain syndrome or trigeminal neuralgia
4.Lower extremity amputations other than toes
5.Participation in another study with an investigational compound within the previous 90 days prior to study medication administration, or concurrent participation in another clinical study
6.Major depression.
7.Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
8.Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that according to Investigators medical judgment: Could interfere with the accurate assessment of safety or efficacy, or, Could potentially affect a patients safety or study outcome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean 24-hour average pain intensity (API) scoreTimepoint: Time Frame: 4 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method Clinician Global Impression of ChangeTimepoint: Time Frame: 4 weeks;Mean night-time API ScoreTimepoint: Time Frame: 4 weeks;Patient Global Impression of ChangeTimepoint: Time Frame: 4 weeks