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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01726413

Enrollment

138

Registered

2012-11-14

Start date

2012-11-30

Completion date

2014-09-30

Last updated

2014-10-02

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

Conditions

Painful Diabetic Peripheral Neuropathy

Keywords

Diabetic neuropathy

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.

Interventions

DRUGGRC 17356

DRUGMatching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Czechia, Germany, India, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026