Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2)

PHASE3CompletedINTERVENTIONAL
Enrollment

460

Participants

Timeline

Start Date

May 31, 1998

Primary Completion Date

January 31, 2005

Study Completion Date

January 31, 2005

Conditions
Diabetic Polyneuropathy
Interventions
DRUG

Thioctic Acid

600mg tablet once daily 4 years double-blind treatment period

DRUG

Placebo

1 tablet once daily 4 years double-blind treatment period

Trial Locations (38)

2650

University Hospital, Hvidovre

3584

University Hospital Utrecht Department of Internal Medicine, Utrecht

10000

University Clinic for Diabetes, Endocrinology and Metabolic, Zagreb

University Clinic of Internal Medicine, Zagreb

10021

Ney York Hospital Cornell Med Center, New York

15213

University of Pittsburgh Medical Center, Pittsburgh

15705

C.H.U.S. General Hospital, Santiago de Compostela

20602

University Clinic, Malmo

23510

Leonard R. Strelitz Diabetes Institutes, Norfolk

27858

East Carolina University, School of Medicine, Greenville

35137

Hospital Geriatrico Diabetological Service, Padua

35205

´Diabetes Care Center, Birmingham

43100

Hosptal of Parma Department of Medicine, Parma

43210

Ohio State University Medical Center, Columbus

44195

The Cleveland Clinic Foundation, Cleveland

55905

Mayo Clinic Rochester, Rochester

60153

Loyola University Medical Center, Maywood

65212

University of Missouri Dept. of Neurology, Columbia

68131

Creighton University Diabetes Center, Omaha

75230

Dallas Diabetes & Endocrine Center, Dallas

77030

Baylor College of Medicine, Houston

80138

Policlinic University, Napoli

85259

Mayo Clinic Arizona, Scottsdale

87108

Lovelace Scientific Resources, Inc., Albuquerque

90805

Medical Building, Long Beach

91010

City of Hope National Medical Center, Duarte

92103

UCSD Neuromuscular Research Program, San Diego

92780

Diabetes Research Center, Tustin

93143

Hospital Jean Verdler, Bondy

94143-0114

University of California, San Francisco

02215

Beth Israel Medical Center, Boston

48019-0205

University of Michigan Medical Center, Ann Arbor

55454-1478

Health Partners Riverside Neurology Clinic, Minneapolis

75325-8858

University of Texas South Western Medical Center, Dallas

78229-3894

Diabetes & Glandular Disease Center, San Antonio

08003

Hospital del Mar Department Neurophysiology, Barcelona

08036

Hospital Clinico y Provincial, Barcelona

M13 9WL

Manchester Royal Infirmary Department of Medicine, Manchester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Clinquest, Inc.

INDUSTRY

collaborator

Ergomed

INDUSTRY

collaborator

Quintiles, Inc.

INDUSTRY

lead

MEDA Pharma GmbH & Co. KG

INDUSTRY