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).

This study has been completed.
Sponsor:
Collaborator:
Glenmark Pharmaceuticals SA
Information provided by (Responsible Party):
Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier:
NCT01726413
First received: November 9, 2012
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Painful Diabetic Peripheral Neuropathy
Drug: GRC 17356
Drug: Matching Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Glenmark Pharmaceuticals Ltd. India:

Primary Outcome Measures:
  • Mean 24-hour average pain intensity (API) score. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean night-time API Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Clinician Global Impression of Change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: November 2012
Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Arm
GRC17356 for daily administration
Drug: GRC 17356
Placebo Comparator: Placebo
Matching placebo for daily administration
Drug: Matching Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726413

Locations
Czech Republic
NeuroHelp s.r.o
Olomouc, Prague, Czech Republic, 772 00
DADO Medical s.r.o
Prague, Czech Republic, 12000
DADO Medical s.r.o
Ricany, Czech Republic
Germany
Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
Mainz, Germany, 55116
India
Bangalore Clinisearch
Bangalore, Karnataka, India, 560043
K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
Belgaum, Karnataka, India, 590010
Jnana Sanjeevani Medical Centre
Bangalore, Karntaka, India, 560078
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India, 452010
Jehangir Clinical development Centre Pvt Ltd
Pune, Maharashtra, India, 411001
Getwell Hospital and Research Centre
Nagpur, Maharastra, India, 440012
MV Hospital for Diabetes (P) Ltd
Chennai, Tamil Nadu, India, 600 013
Kovai Diabetes Speciality Centre and Hospital
Coimbatore, Tamil Nadu, India, 641 009
Arthur Asirvathma Hospital
Madhurai, Tamil Nadu, India, 625020
Maulana Azad Medical College & Associate Hospitals
New Delhi, India, 110002
United Kingdom
ICON Manchester CPU
Manchester, UK, United Kingdom, M15 6SH
Sponsors and Collaborators
Glenmark Pharmaceuticals Ltd. India
Glenmark Pharmaceuticals SA
Investigators
Principal Investigator: Dr. Balamurugan Ramanathan Kovai Diabetes Speciality Centre and Hospital
Principal Investigator: Dr. Vijay Viswanathan MV Hospital for Diabetes (P) Ltd
Principal Investigator: Dr. Mallikarjun V Jali K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
Principal Investigator: Dr. Sunil M Jain TOTALL Diabetes Hormone Institute
Principal Investigator: Dr. Dinesh Dhanwal Maulana Azad Medical College & Associate Hospitals
Principal Investigator: Dr. S Srikanta Jnana Sanjeevani Medical Centre
Principal Investigator: Dr. Jayashri Shembalkar Getwell Hospital and Research Centre
Principal Investigator: Dr Peter Dewland ICON Manchester CPU
Principal Investigator: Dr. Prof Thomas Forst Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
Principal Investigator: Dr. Paramesh Shammana Bangalore Clinisearch
Principal Investigator: Dr. Arthur Asirvatham Arthur Asirvathma Hospital
Principal Investigator: Dr. Mohan Magdum Jehangir Clinical development Centre Pvt Ltd
Principal Investigator: Dr. Blanka Lubenova NeuroHelp s.r.o
Principal Investigator: Dr. David Dolezil DADO Medical s.r.o
  More Information

No publications provided

Responsible Party: Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier: NCT01726413     History of Changes
Other Study ID Numbers: GRC 17536-203, 2012-002320-33
Study First Received: November 9, 2012
Last Updated: October 1, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Glenmark Pharmaceuticals Ltd. India:
Diabetic neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014