A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients).

Overview

Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN. The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.

Full Title of Study: “A Phase II, 4-Week Randomised, 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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2014

Interventions

  • Drug: GRC 17356
  • Drug: Matching Placebo

Arms, Groups and Cohorts

  • Experimental: Test Arm
    • GRC17356 for daily administration
  • Placebo Comparator: Placebo
    • Matching placebo for daily administration

Clinical Trial Outcome Measures

Primary Measures

  • Mean 24-hour average pain intensity (API) score.
    • Time Frame: Week 4

Secondary Measures

  • Mean night-time API Score
    • Time Frame: 4 weeks
  • Patient Global Impression of Change
    • Time Frame: 4 weeks
  • Clinician Global Impression of Change
    • Time Frame: 4 weeks

Participating in This Clinical Trial

Inclusion Criteria

1. Patients willing to provide voluntary written informed consent 2. Male and female 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 Exclusion Criteria:

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 Investigator's medical judgment: Could interfere with the accurate assessment of safety or efficacy, or, Could potentially affect a patient's safety or study outcome

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Glenmark Pharmaceuticals Ltd. India
  • Collaborator
    • Glenmark Pharmaceuticals S.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Balamurugan Ramanathan, Principal Investigator, Kovai Diabetes Speciality Centre and Hospital
    • Dr. Vijay Viswanathan, Principal Investigator, MV Hospital for Diabetes (P) Ltd
    • Dr. Mallikarjun V Jali, Principal Investigator, K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
    • Dr. Sunil M Jain, Principal Investigator, TOTALL Diabetes Hormone Institute
    • Dr. Dinesh Dhanwal, Principal Investigator, Maulana Azad Medical College & Associate Hospitals
    • Dr. S Srikanta, Principal Investigator, Jnana Sanjeevani Medical Centre
    • Dr. Jayashri Shembalkar, Principal Investigator, Getwell Hospital and Research Centre
    • Dr Peter Dewland, Principal Investigator, ICON Manchester CPU
    • Dr. Prof Thomas Forst, Principal Investigator, Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
    • Dr. Paramesh Shammana, Principal Investigator, Bangalore Clinisearch
    • Dr. Arthur Asirvatham, Principal Investigator, Arthur Asirvathma Hospital
    • Dr. Mohan Magdum, Principal Investigator, Jehangir Clinical Development Centre Pvt. Ltd.
    • Dr. Blanka Lubenova, Principal Investigator, NeuroHelp s.r.o
    • Dr. David Dolezil, Principal Investigator, DADO Medical s.r.o

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