Trial | NCT01726413  Report issue

Title

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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    grc 17356 ...

  • Study Participants

    138
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 Started
Nov 30
2012
Primary Completion
Aug 31
2014
Study Completion
Sep 30
2014
Last Update
Oct 02
2014
Estimate

Drug GRC 17356

Drug Matching Placebo

Test Arm Experimental

GRC17356 for daily administration

Placebo Placebo Comparator

Matching placebo for daily administration

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted