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).
NCT ID: NCT01726413
Last Updated: 2014-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
138 participants
INTERVENTIONAL
2012-11-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test Arm
GRC17356 for daily administration
GRC 17356
Placebo
Matching placebo for daily administration
Matching Placebo
Interventions
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GRC 17356
Matching Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Glenmark Pharmaceuticals Ltd. India
INDUSTRY
Glenmark Pharmaceuticals S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Balamurugan Ramanathan
Role: PRINCIPAL_INVESTIGATOR
Kovai Diabetes Speciality Centre and Hospital
Dr. Vijay Viswanathan
Role: PRINCIPAL_INVESTIGATOR
MV Hospital for Diabetes (P) Ltd
Dr. Mallikarjun V Jali
Role: PRINCIPAL_INVESTIGATOR
K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
Dr. Sunil M Jain
Role: PRINCIPAL_INVESTIGATOR
TOTALL Diabetes Hormone Institute
Dr. Dinesh Dhanwal
Role: PRINCIPAL_INVESTIGATOR
Maulana Azad Medical College & Associate Hospitals
Dr. S Srikanta
Role: PRINCIPAL_INVESTIGATOR
Jnana Sanjeevani Medical Centre
Dr. Jayashri Shembalkar
Role: PRINCIPAL_INVESTIGATOR
Getwell Hospital and Research Centre
Dr Peter Dewland
Role: PRINCIPAL_INVESTIGATOR
ICON Manchester CPU
Dr. Prof Thomas Forst
Role: PRINCIPAL_INVESTIGATOR
Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
Dr. Paramesh Shammana
Role: PRINCIPAL_INVESTIGATOR
Bangalore Clinisearch
Dr. Arthur Asirvatham
Role: PRINCIPAL_INVESTIGATOR
Arthur Asirvathma Hospital
Dr. Mohan Magdum
Role: PRINCIPAL_INVESTIGATOR
Jehangir Clinical Development Centre Pvt. Ltd.
Dr. Blanka Lubenova
Role: PRINCIPAL_INVESTIGATOR
NeuroHelp s.r.o
Dr. David Dolezil
Role: PRINCIPAL_INVESTIGATOR
DADO Medical s.r.o
Locations
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NeuroHelp s.r.o
Olomouc, Prague, Czechia
DADO Medical s.r.o
Prague, Prague, Czechia
DADO Medical s.r.o
Říčany, Ricany, Czechia
Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
Mainz, Germany, Germany
Bangalore Clinisearch
Bangalore, Karnataka, India
K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
Belagavi, Karnataka, India
Jnana Sanjeevani Medical Centre
Bangalore, Karntaka, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India
Getwell Hospital and Research Centre
Nagpur, Maharashtra, India
Jehangir Clinical development Centre Pvt Ltd
Pune, Maharashtra, India
Maulana Azad Medical College & Associate Hospitals
New Delhi, New Delhi, India
MV Hospital for Diabetes (P) Ltd
Chennai, Tamil Nadu, India
Kovai Diabetes Speciality Centre and Hospital
Coimbatore, Tamil Nadu, India
Arthur Asirvathma Hospital
Madurai, Tamil Nadu, India
ICON Manchester CPU
Manchester, UK, United Kingdom
Countries
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References
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Jain SM, Balamurugan R, Tandon M, Mozaffarian N, Gudi G, Salhi Y, Holland R, Freeman R, Baron R. Randomized, double-blind, placebo-controlled trial of ISC 17536, an oral inhibitor of transient receptor potential ankyrin 1, in patients with painful diabetic peripheral neuropathy: impact of preserved small nerve fiber function. Pain. 2022 Jun 1;163(6):e738-e747. doi: 10.1097/j.pain.0000000000002470. Epub 2021 Sep 2.
Other Identifiers
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2012-002320-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GRC 17536-203
Identifier Type: -
Identifier Source: org_study_id
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