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).
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Painful Diabetic Peripheral Neuropathy |
Drug: GRC 17356 Drug: Matching Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official 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. |
- Mean 24-hour average pain intensity (API) score. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 138 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Test Arm
GRC17356 for daily administration
|
Drug: GRC 17356 |
|
Placebo Comparator: Placebo
Matching placebo for daily administration
|
Drug: Matching Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Ajay Vats | +91-22-67720000 ext 3698 | ajayvats@glenmarkpharma.com |
| Contact: Dr Shailendra Sachan | +91-22-67720000 ext 3502 | shailendrasachan@glenmarkpharma.com |
| Germany | |
| Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A) | Recruiting |
| Mainz, Germany, 55116 | |
| Contact: Dr. Prof Thomas Forst | |
| Principal Investigator: Dr. Prof Thomas Forst | |
| India | |
| Bangalore Diabetes Hospital | Not yet recruiting |
| Bangalore, Karnataka, India, 560052 | |
| Contact: Dr. K M Prasanna Kumar | |
| Principal Investigator: Dr. K M Prasanna Kumar | |
| K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre | Not yet recruiting |
| Belgaum, Karnataka, India, 590010 | |
| Contact: Dr. Mallikarjun V Jali | |
| Principal Investigator: Dr. Mallikarjun V Jali | |
| Jnana Sanjeevani Medical Centre | Not yet recruiting |
| Bangalore, Karntaka, India, 560078 | |
| Contact: Dr. S Srikanta | |
| Principal Investigator: Dr. S Srikanta | |
| TOTALL Diabetes Hormone Institute | Not yet recruiting |
| Indore, Madhya Pradesh, India, 452010 | |
| Contact: Dr. Sunil M Jain | |
| Principal Investigator: Dr. Sunil M Jain | |
| Getwell Hospital and Research Centre | Not yet recruiting |
| Nagpur, Maharastra, India, 440012 | |
| Contact: Dr. Jayashri Shembalkar | |
| Principal Investigator: Dr. Jayashri Shembalkar | |
| Institute Of Medical Science and SUM Hospital | Not yet recruiting |
| Bhubaneshwar, Orissa, India, 751003 | |
| Contact: Dr. Abhay Kumar Sahoo | |
| Principal Investigator: Dr. Abhay Kumar Sahoo | |
| MV Hospital for Diabetes (P) Ltd | Not yet recruiting |
| Chennai, Tamil Nadu, India, 600 013 | |
| Contact: Dr. Vijay Viswanathan | |
| Principal Investigator: Dr. Vijay Viswanathan | |
| Kovai Diabetes Speciality Centre and Hospital | Not yet recruiting |
| Coimbatore, Tamil Nadu, India, 641 009 | |
| Contact: Dr. Balamurugan Ramanathan | |
| Principal Investigator: Dr. Balamurugan Ramanathan | |
| Maulana Azad Medical College & Associate Hospitals | Not yet recruiting |
| New Delhi, India, 110002 | |
| Contact: Dr. Dinesh Dhanwal | |
| Principal Investigator: Dr. Dinesh Dhanwal | |
| United Kingdom | |
| ICON Manchester CPU | Recruiting |
| Manchester, UK, United Kingdom, M15 6SH | |
| Contact: Dr Peter Dewland | |
| Principal Investigator: Dr.Peter Dewland | |
| 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. K M Prasanna Kumar | Bangalore Diabetes Hospital |
| 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. Abhay Kumar Sahoo | Institute Of Medical Science and SUM Hospital |
| 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) |
More Information
No publications provided
| Responsible Party: | Glenmark Pharmaceuticals Ltd. India |
| ClinicalTrials.gov Identifier: | NCT01726413 History of Changes |
| Other Study ID Numbers: | GRC 17536-203, 2012-002320-33 |
| Study First Received: | November 9, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by Glenmark Pharmaceuticals Ltd. India:
|
Diabetic neuropathy |
Additional relevant MeSH terms:
|
Pain Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Diabetic Neuropathies |
Nervous System Diseases Signs and Symptoms Neuromuscular Diseases Poisoning Substance-Related Disorders Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013