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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).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01726413
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : October 2, 2014
Glenmark Pharmaceuticals S.A.
Information provided by (Responsible Party):
Glenmark Pharmaceuticals Ltd. India

Brief Summary:
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 or disease Intervention/treatment Phase
Painful Diabetic Peripheral Neuropathy Drug: GRC 17356 Drug: Matching Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : November 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Test Arm
GRC17356 for daily administration
Drug: GRC 17356
Placebo Comparator: Placebo
Matching placebo for daily administration
Drug: Matching Placebo

Primary Outcome Measures :
  1. Mean 24-hour average pain intensity (API) score. [ Time Frame: Week 4 ]

Secondary Outcome Measures :
  1. Mean night-time API Score [ Time Frame: 4 weeks ]
  2. Patient Global Impression of Change [ Time Frame: 4 weeks ]
  3. Clinician Global Impression of Change [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01726413

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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
Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
Mainz, Germany, 55116
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 S.A.
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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

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Responsible Party: Glenmark Pharmaceuticals Ltd. India Identifier: NCT01726413     History of Changes
Other Study ID Numbers: GRC 17536-203
2012-002320-33 ( EudraCT Number )
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: October 2014

Keywords provided by Glenmark Pharmaceuticals Ltd. India:
Diabetic neuropathy

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