Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet

PHASE2CompletedINTERVENTIONAL
Enrollment

842

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

November 30, 2008

Study Completion Date

January 31, 2009

Conditions
Obesity
Interventions
DRUG

S-2367 Placebo

Four placebo tablets (total dose = 0 mg/day S-2367) administered orally once daily with AM (ante meridiem) meal while on both LCD (low calorie diet for 6 weeks) and RCD (reduced calorie diet for 54 weeks) for a total of 60 weeks

DRUG

S-2367 1600 mg q.d. 54 Weeks

Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on RCD for a total of 54 weeks

DRUG

S-2367 1600 mg q.d. 60 weeks

Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on both LCD and RCD for a total of 60 weeks

OTHER

LCD (low calorie diet)

A low calorie diet was utilized during the first 6 weeks of the study

OTHER

RCD (reduced calorie diet)

A reduced calorie diet was used during the last 54 weeks for the study

Trial Locations (40)

13760

Endwell

19020

Bensalem

27103

Winston-Salem

27215

Burlington

29464

Mt. Pleasant

30338

Atlanta

30904

Augusta

32259

Jacksonville

32809

Orlando

33143

South Miami

34471

Ocala

35209

Birmingham

35801

Huntsville

37203

Nashville

40509

Lexington

43212

Columbus

45219

Cincinnati

53226

Wauwatosa

55430

Brooklyn Center

60031

Gurnee

60610

Chicago

63141

St Louis

64114

Kansas City

67207

Wichita

68510

Lincoln

73099

Yukon

76135

Fort Worth

78130

New Braunfels

78229

San Antonio

83704

Boise

84088

West Jordan

85014

Phoenix

89146

Las Vegas

92108

San Diego

92708

Fountain Valley

94102

San Francisco

06708

Waterbury

02135

Boston

02747

South Dartmouth

08817

Edison

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shionogi

INDUSTRY

NCT00748605 - Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet | Biotech Hunter | Biotech Hunter