NCT Number: NCT01726413
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).
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.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
NeuroHelp s.r.o, Olomouc, Prague, Czechia
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Matching Placebo
DrugPrimary outcomes
-
Mean 24-hour average pain intensity (API) score.
Time frame: Week 4
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Glenmark Pharmaceuticals Ltd. India
Industry
Collaborators
- Glenmark Pharmaceuticals S.A.
Registry information
Official study title
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.
Important dates
- Study start
- 2012
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Nov 14, 2012
- Registry last updated
- Oct 2, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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