CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 128 enrolled
Drug / intervention
DA-9801 300mg +3 moredrug
Likely dose
DA-9801 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01822925
NCT01822925Phase 2Completed
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A Phase II Randomized, Double-Blind, Parallel Group, Dose-Ranging, Placebo-Controlled Study to Assess the Safety And Effectiveness Of DA-9801 in the Treatment of Subjects With Diabetic Neuropathy

NeuroBo Pharmaceuticals Inc.·interventional·Posted Apr 4, 2013·Updated Mar 20, 2020

In Brief

A Phase 2 clinical trial evaluating DA-9801 300mg, DA-9801 600mg, and 2 other interventions for Diabetic Neuropathy. Completed, enrolled 128 participants across 14 sites.

Detailed Summary

To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain in subjects with diabetic neuropathic pain compared to their baseline values.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy
CountriesUnited States
CollaboratorsDong-A ST Co., Ltd.

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2013
Enrollment StartNov 1, 2013
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.2 years ago

Interventions

DA-9801 300mgdrug

300 mg of DA-9801 in tablet form, 100 mg to be taken 3 times daily for 12 weeks.

DA-9801 600mgdrug

600 mg of DA-9801 in tablet form, 200 mg to be taken 3 times daily for 12 weeks.

DA-9801 900mgdrug

900 mg of DA-9801 in tablet form, to be taken 300 mg to be taken 3 times daily for 12 weeks.

Placebodrug

Placebo, in tablet form, to be taken 3 times daily for 12 weeks. The placebo is the same formulation as DA-9801 except that it does not contain the active pharmaceutical ingredient.