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).

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.

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.

Study Overview

• Status: Completed
• Conditions: Painful Diabetic Peripheral Neuropathy
• Intervention / Treatment: Drug: Matching Placebo; Drug: GRC 17356

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czech Republic
  • Prague, Czech Republic, 12000
    • DADO Medical s.r.o
  • Ricany, Czech Republic
    • DADO Medical s.r.o
  • Prague
    • Olomouc, Prague, Czech Republic, 772 00
      • NeuroHelp s.r.o
• Germany
  • Mainz, Germany, 55116
    • Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
• India
  • New Delhi, India, 110002
    • Maulana Azad Medical College & Associate Hospitals
  • Karnataka
    • Bangalore, Karnataka, India, 560043
      • Bangalore Clinisearch
    • Belgaum, Karnataka, India, 590010
      • K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
  • Karntaka
    • Bangalore, Karntaka, India, 560078
      • Jnana Sanjeevani Medical Centre
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452010
      • TOTALL Diabetes Hormone Institute
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • Jehangir Clinical Development Centre Pvt Ltd
  • Maharastra
    • Nagpur, Maharastra, India, 440012
      • Getwell Hospital and Research Centre
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 013
      • MV Hospital for Diabetes (P) Ltd
    • Coimbatore, Tamil Nadu, India, 641 009
      • Kovai Diabetes Speciality Centre and Hospital
    • Madhurai, Tamil Nadu, India, 625020
      • Arthur Asirvathma Hospital
• United Kingdom
  • UK
    • Manchester, UK, United Kingdom, M15 6SH
      • ICON Manchester CPU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Arm; GRC17356 for daily administration	Drug: GRC 17356
Placebo Comparator: Placebo; Matching placebo for daily administration	Drug: Matching Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Ltd. India
• Collaborators: Glenmark Pharmaceuticals S.A.
• 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

Publications and helpful links

General Publications

• Jain SM, Balamurugan R, Tandon M, Mozaffarian N, Gudi G, Salhi Y, Holland R, Freeman R, Baron R. Randomized, double-blind, placebo-controlled trial of ISC 17536, an oral inhibitor of transient receptor potential ankyrin 1, in patients with painful diabetic peripheral neuropathy: impact of preserved small nerve fiber function. Pain. 2022 Jun 1;163(6):e738-e747. doi: 10.1097/j.pain.0000000000002470. Epub 2021 Sep 2.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 9, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (Estimate): November 14, 2012

Study Record Updates

• Last Update Posted (Estimate): October 2, 2014
• Last Update Submitted That Met QC Criteria: October 1, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Diabetic neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies
• Other Study ID Numbers: GRC 17536-203; 2012-002320-33 (EudraCT Number)