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Study of DA-9801 to Treat Diabetic Neuropathy

NCT01822925 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2020-03-20

Study results available
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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.

Conditions

  • Diabetic Neuropathy

Interventions

DRUG

DA-9801 300mg

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

DRUG

DA-9801 600mg

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

DRUG

DA-9801 900mg

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

DRUG

Placebo

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.

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    collaborator INDUSTRY

  • NeuroBo Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Gabriel Maislos, D.P.M · Houston Foot & Ankle Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01822925 on ClinicalTrials.gov