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).

NCT01726413 | Completed Phase 2

• 2 other identifiers: GRC 17536-2032012-002320-33
• Study Type: interventional
• Target: 138
• Locations: 4 countries
• Sites: 15

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.

Conditions

Painful Diabetic Peripheral Neuropathy

Keywords

Diabetic neuropathy

Outcome Measures

Primary Outcomes (1)

• Mean 24-hour average pain intensity (API) score.

  Week 4

Secondary Outcomes (3)

• Mean night-time API Score

  4 weeks

• Patient Global Impression of Change

  4 weeks

• Clinician Global Impression of Change

  4 weeks

Study Arms (2)

Test Arm

EXPERIMENTAL

GRC17356 for daily administration

Drug: GRC 17356

Placebo

PLACEBO COMPARATOR

Matching placebo for daily administration

Drug: Matching Placebo

Interventions

GRC 17356 DRUG

Test Arm

Matching Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients willing to provide voluntary written informed consent
• Male and female patients ≥18 yrs and ≤75 yrs
• Patients with diabetes mellitus with painful peripheral neuropathy for at least 6 months
• A baseline 24-hour average daily pain intensity score ≥5
• Women must be of non child-bearing potential, defined as post menopausal or surgically sterile

You may not qualify if:

• Other chronic pain conditions not associated with DPN, that may confound the assessment of neuropathic pain
• Other causes of neuropathy or lower extremity pain
• Complex regional pain syndrome or trigeminal neuralgia
• Lower extremity amputations other than toes
• 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
• Major depression.
• 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.
• 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

Sponsors & Collaborators

• Glenmark Pharmaceuticals Ltd. India: lead
• Glenmark Pharmaceuticals S.A.: collaborator

Study Sites (15)

NeuroHelp s.r.o

Olomouc, Prague, 772 00, Czechia

Location

DADO Medical s.r.o

Prague, Prague, 12000, Czechia

Location

DADO Medical s.r.o

Říčany, Ricany, Czechia

Location

Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)

Mainz, Germany, 55116, Germany

Location

Bangalore Clinisearch

Bangalore, Karnataka, 560043, India

Location

K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre

Belagavi, Karnataka, 590010, India

Location

Jnana Sanjeevani Medical Centre

Bangalore, Karntaka, 560078, India

Location

TOTALL Diabetes Hormone Institute

Indore, Madhya Pradesh, 452010, India

Location

Getwell Hospital and Research Centre

Nagpur, Maharashtra, 440012, India

Location

Jehangir Clinical development Centre Pvt Ltd

Pune, Maharashtra, 411001, India

Location

Maulana Azad Medical College & Associate Hospitals

New Delhi, New Delhi, 110002, India

Location

MV Hospital for Diabetes (P) Ltd

Chennai, Tamil Nadu, 600 013, India

Location

Kovai Diabetes Speciality Centre and Hospital

Coimbatore, Tamil Nadu, 641 009, India

Location

Arthur Asirvathma Hospital

Madurai, Tamil Nadu, 625020, India

Location

ICON Manchester CPU

Manchester, UK, M15 6SH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34490850 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 14, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 2, 2014

Record last verified: 2014-10

Locations

DE (1); GB (1); IN (10); CZ (3)