Evaluating a Nitric Oxide Generator, Nebivolol as a Disease Modifier in Patients With Diabetic Neuropathy.
Recruiting
Phase 2
Phase 3
Interventional Study
Diabetic Neuropathy Peripheral
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 18
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- St. John's Research Institute · Other
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About This Trial
The goal of this clinical trial is to test in patients with diabetic neuropathy,
* Can Nevibolol at a dose of 2.5 mg- 10 mg compared with standard pain modulating treatment conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up.
* Can Nevibolol at a dose of 2.5 mg- 10 mg compared with a combination of Alpha Lipoic Acid (600 mg/day)+EPALRESTAT (150 mg/d…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patients aged \>= 18 years diagnosed with diabetes mellitus, of a duration of \<= 5 years since their diagnosis
2. HbA1c \< 9 at enrolment with stable glycemic control for the last three months
3. Neuropathy meeting the following 'Toronto criteria' (8) - (a) abnormal nerve co…
Contacts
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