Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN)

NCT03297294 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2021-10-08

Study results available
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Summary

The purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN).

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

EMA401

capsules, oral

DRUG

Placebo

Placebo to EMA401 capsules, oral

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2019-03-25
Completion
2019-03-25
FDA Drug
Yes

Countries

  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

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Entities

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 NCT03297294 on ClinicalTrials.gov