Status:
WITHDRAWN
Safety and Efficacy Study of BC-DN-01 in Painful Diabetic Peripheral Neuropathy
Lead Sponsor:
BioChemics, Inc.
Collaborating Sponsors:
Harrison Clinical Research
Conditions:
Diabetic Neuropathy, Painful
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A combined Phase 1 \& 2 study to evaluate the safety and effectiveness of a new diabetic neuropathy topical cream, containing benfotiamine, will be performed at 5 clinical sites and plans for BC-DN-01...
Detailed Description
The study will be performed at 5 clinical sites and plans for BC-DN-01 administration in up to 135 volunteer patients using a standard Phase 1 + 2 design. Based on conservative but approximate drop-ou...
Eligibility Criteria
Inclusion
- Current diagnosis of Type I or II diabetes mellitus according to the American Diabetes Association Criteria of FPG≥ 7.0 mmol/l (126 mg/dl)
- A current or historical reading of HbA1c 6.5-11%, using a test performed in a clinical laboratory using a method that is NGSP certified and standardised to the DCCT assay.
- Ability to understand the nature of the trial and willingness to participate, documented by written informed consent.
- Willingness and ability to comply with the study protocol requirements for the duration of the study.
- Males and females of any ethnic origin and ≥18 years of age.
- Negative serum pregnancy test at screening and a negative urine pregnancy test at randomisation, for women of childbearing potential only and assurance from the patient (males and females) of using satisfactory contraception methods (refer to section 4.9.6).
- If on anti-diabetic medication, must have been on a stable therapeutic regimen for at least 30 days prior to randomisation.
- Phase 2 - Peroneal Motor Nerve Conduction Velocity measurements 30-40 m/s. indicating a mild to moderate case of diabetic peripheral neuropathy
- Phase 2 - Scores on the Brief Pain Inventory of ≥4.
- An ability to apply topical medication to both legs from the knee to the toes, either by themselves or have a documentation of an assistant or partner to help with the administration of the trial drug product twice a day for the 12-week treatment period.
- Patient must be willing to sign a Consent form to participate in this clinical trial.
- Patient must be willing to sign a consent form to be sent to their primary physician to inform that the patient will stop taking disallowed concomitant medications prescribed by the physician.
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Exclusion
- Participation in any investigational drug study within 4 months preceding randomisation of this study.
- Pregnancy, lactation, fertility without adequate protection against pregnancy (refer to section 4.9.6).
- A serum pregnancy test will be performed for women of childbearing potential with the haematological and clinical chemistry evaluations at screening and a urine pregnancy test immediately prior to randomisation.
- If the patient becomes pregnant during the study, the patient's participation in the remainder of the study will be terminated.
- Phase 2 - Severe neuropathy (PMNCV \< 30 m/s, prior amputations at the foot level and Charcot disease).
- Current severe peripheral arterial disease requiring surgical intervention (however patients with previous successful intervention 12 weeks or more prior to randomisation will be eligible for the study (See Section 4.2.2.1 Peripheral Arterial Disease Determination).
- End stage renal failure requiring dialysis or renal transplantation and patients who are expected to receive dialysis or transplantation in the near future should be excluded from the study.
- Presence of any serious disease, including those of hepatic, hematologic, neurologic, or immune origin or an active malignant disease, which in the opinion of the investigator would affect response to pain relief treatment.
- Presence of peripheral pain not associated with DPN, mono-neuropathies or proximal neuropathies, or central pain, which in the opinion of the investigator would affect response to pain relief treatment.
- Presence of a medical condition diagnosed with other known causes of non-Diabetic Peripheral Neuropathy.
- Known to be currently abusing alcohol or drugs.
- Presence of acute skin disease or infection such as erysipelas and vasculitis of the lower extremities.
- Current oral or topical use of benfotiamine or BC-DN-01 products.
- Hypersensitivity to benfotiamine or any component of BC-DN-01.
- Concurrent administration or use of Lyrica, Cymbalta, or capsaicin use within the 2 weeks prior to randomisation (see Appendix 12.3 for full list of disallowed concomitant medications).
- Any factors which, in the opinion of the investigator, will affect the patient's ability to safely participate in the study and meet study objectives.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01793350
Start Date
June 1 2013
End Date
December 1 2014
Last Update
February 25 2015
Active Locations (5)
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1
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
2
Ipswich Hospital
Ipswich, Suffolk, United Kingdom, IP4 5PD
3
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom, B9 5SS
4
MAC Clinical Research
Manchester, United Kingdom, M32 0UT