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).

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003347

Enrollment

138

Registered

2013-02-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Painful Diabetic Peripheral Neuropathy

Interventions

Intervention1: GRC 17536: BID for 4 weeks, oral adminstration Control Intervention1: Matching Placebo: BID for 4 weeks, oral adminstration Control Intervention2: a: a

Eligibility

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
Mean 24-hour average pain intensity (API) scoreTimepoint: Time Frame: 4 weeks	—

Secondary

Measure	Time frame
Clinician Global Impression of ChangeTimepoint: Time Frame: 4 weeks;Mean night-time API ScoreTimepoint: Time Frame: 4 weeks;Patient Global Impression of ChangeTimepoint: Time Frame: 4 weeks	—

Countries

Czech Republic, Germany, India, United Kingdom

Contacts

Public ContactDr Shailendra Sachan

Glenmark Pharmaceuticals Ltd

venkateshans@glenmarkpharma.com912267720000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026