Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

PHASE3CompletedINTERVENTIONAL
Enrollment

1,381

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
Onychomycosis
Interventions
DRUG

Itraconazole 100mg capsules

Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit.

DRUG

Itraconazole 200mg tablets

Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.

DRUG

Placebo tablets

Placebo tablets are the same as the Itraconazole tablets but without the active drug included. Subjects took one tablet once per day after a full meal. The last tablet was taken the day before the Week 12 visit.

Trial Locations (68)

10021

Skin Specialty Group, New York

10032

Columbia University Medical Center, New York

27262

Dermatology Consulting Services, High Point

29617

Radiant Research - Greenville, Greenville

29621

Radiant Research - Anderson, Anderson

29651

Dr. J. M. Humeniuk, Greer

30078

Gwinnett Clinical Research Center Inc., Snellville

30106

Radiant Research - Atlanta West, Austell

32174

Advanced Dermatology and Cosmetic Surgery, Ormond Beach

33144

International Dermatology Research Inc., Miami

33175

FMX Research Corporation, Miami

33180

Dr. Stephen Horwitz, Aventure

33407

Radiant Research - West Palm Beach, West Palm Beach

33781

Radiant Research - St. Petersburg, St. Petersburg

35209

Radiant Research -Birmingham, Birmingham

35233

University of Alabama School of Medicine, Birmingham

37215

Tennessee Clinical Research Center, Nashville

37917

Dermatology Associates of Knoxville, Knoxville

38138

Dermatology East, Germantown

45219

Dermatology Clinical Research Center, Cincinnati

45249

Radiant Research - Cincinnati, Cincinnati

48083

Skin and Vein Center, Troy

48103

Dr. David Fivenson, Ann Arbour

53209

Advanced Healthcare S. C., Milwaukee

53719

Madison Skin and Research Inc., Madison

55417

VA Medical Center, Minneapolis

55432

Minnesota Clinical Study Center, Fridley

60610

Radiant Research - Chicago, Chicago

66215

Radiant Research - Kansas City, Overland Park

71913

Burke Pharmaceutical Research, Hot Springs

75231

Radiant Research - Dallas North, Dallas

77802

Dr. Terry Jones, Bryan

78229

Dr. Stephen Miller, San Antoinio

Endeavor Clinical Trials, San Antonio

78759

DermResearch Inc., Austin

80112

Meridian Skincare, Englewood

83704

Northwest Clinical Trials, Boise

84088

South Valley Dermatology Center, West Jordan

84124

Dermatology Research Center, Salt Lake City

85710

Radiant Research - Tucson, Tuscon

87106

Dr. Eduardo Tschen, Albuquerque

92117

Skin Surgey Medical Group, San Diego

92123

Therapeutics Clinical Research, San Diego

94538

East Bay Dermatology Medical Group Inc., Fremont

95405

Radiant Research - Santa Rosa, Santa Rosa

97210

Northwest Cutaneous Research, Portland

97223

Oregon Medical Research Center, Portland

98499

Radiant Research - Tacoma, Tacoma

235507

Pariser Dermatology Specialists Ltd., Norfolk

94143-0517

University of California, San Francisco

06511

The Savin Center, New Haven

02903

Rhode Island Hospital, Providence

T2S3B3

Dr. Kirk Barber, Calgary

V5Z3Y1

Dr. Richard Thomas, Vancouver

E1C8X3

Dr. Marc Bourcier, Moncton

N5X2P1

Dr. Aditja Gupta, London

L3P7N8

Dr. Chuck Lynde, Markham

L6K1E1

EntraLogix, Oakville

N8W5L7

Dr. Jerry Tan, Windsor

H2K4L5

Dr. Robert Bissonnette, Montreal

Unknown

Edifico Professional Guarionex Lopez, Santo Domingo

Dr. Manuel Briones, Guayaquil

Centro Orquidea Blanca, San Pedro

Clinica Metropolis II, Panama City

Langeberg Medical Centre, Cape Town

University of Cape Town, Cape Town

Dr. Z. F. Ahmed Vawda, Durban

DJW Navorsing, Krugerson

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Stiefel, a GSK Company

INDUSTRY