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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).

This study has been completed.
Sponsor:
Collaborator:
Glenmark Pharmaceuticals S.A.
Information provided by (Responsible Party):
Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier:
NCT01726413
First received: November 9, 2012
Last updated: October 1, 2014
Last verified: October 2014

November 9, 2012
October 1, 2014
November 2012
August 2014   (final data collection date for primary outcome measure)
Mean 24-hour average pain intensity (API) score. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01726413 on ClinicalTrials.gov Archive Site
  • Mean night-time API Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Clinician Global Impression of Change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Painful Diabetic Peripheral Neuropathy
  • Drug: GRC 17356
  • Drug: Matching Placebo
  • Experimental: Test Arm
    GRC17356 for daily administration
    Intervention: Drug: GRC 17356
  • Placebo Comparator: Placebo
    Matching placebo for daily administration
    Intervention: Drug: Matching Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
September 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   India,   United Kingdom
 
NCT01726413
GRC 17536-203, 2012-002320-33
No
Glenmark Pharmaceuticals Ltd. India
Glenmark Pharmaceuticals Ltd. India
Glenmark Pharmaceuticals S.A.
Principal Investigator: Dr. Balamurugan Ramanathan Kovai Diabetes Speciality Centre and Hospital
Principal Investigator: Dr. Vijay Viswanathan MV Hospital for Diabetes (P) Ltd
Principal Investigator: Dr. Mallikarjun V Jali K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
Principal Investigator: Dr. Sunil M Jain TOTALL Diabetes Hormone Institute
Principal Investigator: Dr. Dinesh Dhanwal Maulana Azad Medical College & Associate Hospitals
Principal Investigator: Dr. S Srikanta Jnana Sanjeevani Medical Centre
Principal Investigator: Dr. Jayashri Shembalkar Getwell Hospital and Research Centre
Principal Investigator: Dr Peter Dewland ICON Manchester CPU
Principal Investigator: Dr. Prof Thomas Forst Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
Principal Investigator: Dr. Paramesh Shammana Bangalore Clinisearch
Principal Investigator: Dr. Arthur Asirvatham Arthur Asirvathma Hospital
Principal Investigator: Dr. Mohan Magdum Jehangir Clinical development Centre Pvt Ltd
Principal Investigator: Dr. Blanka Lubenova NeuroHelp s.r.o
Principal Investigator: Dr. David Dolezil DADO Medical s.r.o
Glenmark Pharmaceuticals Ltd. India
October 2014

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