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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01556152
Other study ID # GRC 17536-201
Secondary ID 2011-005879-16
Status Withdrawn
Phase Phase 2
First received March 15, 2012
Last updated November 9, 2012

Study information

Verified date November 2012
Source Glenmark Pharmaceuticals Ltd. India
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioids, and anti epileptic drugs. However, only two drugs (duloxetine and pregabalin) have been formally approved by the EMEA and the US FDA for the treatment of painful DPN. Generally, 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.

This is randomized, double-blind, placebo-controlled, parallel group study. The study will include patients with type 1 or type 2 diabetes mellitus with history of pain attributed to DPN for least 6 months and no greater than 5 years.

Patients will be recruited after providing written informed consent.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
GRC 17536 (Medium Dose)
1 BD for 28 days
GRC 17536 (Low Dose)
1 BD for 28 Days
Placebo
Matching Placebo for 28 Days

Locations

Country Name City State
Germany Site 2 Mainz
United Kingdom Site 1 Manchester

Sponsors (2)

Lead Sponsor Collaborator
Glenmark Pharmaceuticals Ltd. India Glenmark Pharmaceuticals S.A.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean 24-hour average pain intensity (API) score 4 weeks No
Secondary Mean night-time API Score 4 weeks No
Secondary Patient Global Impression of Change 4 weeks No
Secondary Clinician Global Impression of Change 4 weeks No
Secondary Adverse events (AE) 4 weeks Yes
Secondary Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24 4 weeks No
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