A clinical trial to study the effects of GRC 17536 in patients with painful diabetic peripheral neuropathy (painful extremities due to peripheral nerve damage in diabetic patients).

Phase 2

Completed

• Conditions: Painful Diabetic Peripheral Neuropathy

• Registration Number: CTRI/2013/02/003347
• Lead Sponsor: Glenmark Pharmaceuticals SA

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.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

The study will be conducted in 10 centres in India, and 1 each, in Germany and the UK.

The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-02
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

1.Patients willing to provide voluntary written informed consent 2.Male and female (women of non child-bearing potential) 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 Investigators medical judgment: Could interfere with the accurate assessment of safety or efficacy, or, Could potentially affect a patients safety or study outcome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean 24-hour average pain intensity (API) score	Time Frame: 4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Arthur Asirvatham Hospital; 🇮🇳 Madurai, TAMIL NADU, India

Bangalore Clinisearch; 🇮🇳 Bangalore, KARNATAKA, India

Getwell Hospital and Research Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

Jehangir Clinical Development Centre Pvt. Ltd.; 🇮🇳 Pune, MAHARASHTRA, India

Jnana Sanjeevani Medical Centre; 🇮🇳 Bangalore, KARNATAKA, India

K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre; 🇮🇳 Belgaum, KARNATAKA, India

Kovai Diabetes Speciality Centre and Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Maulana Azad Medical College & Associate Hospitals; 🇮🇳 Delhi, DELHI, India

MV Hospital for Diabetes (P) Ltd; 🇮🇳 Chennai, TAMIL NADU, India

TOTALL Diabetes Hormone Institute, A unit of Hormone Research Institute Pvt. Ltd; 🇮🇳 Indore, MADHYA PRADESH, India

Arthur Asirvatham Hospital

🇮🇳Madurai, TAMIL NADU, India

Dr Arthur Asirvatham

Principal investigator

09443751977

asirvath.cr@gmail.com