Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets

PHASE3CompletedINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Low Back Pain
Interventions
DRUG

Hydrocodone ER

Participants were instructed to take hydrocodone ER tablets orally with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.

DRUG

Placebo

During the double-blind titration period used in the original protocol, placebo tablets matching each dose of hydrocodone bitartrate ER tablets (active drug) were used to maintain the blind but not for purposes of comparison.

Trial Locations (61)

Unknown

Teva Investigational Site 10412, Birmingham

Teva Investigational Site 10426, Mobile

Teva Investigational Site 10436, Montgomery

Teva Investigational Site 10363, Phoenix

Teva Investigational Site 10366, Phoenix

Teva Investigational Site 10437, Tucson

Teva Investigational Site 10358, Anaheim

Teva Investigational Site 10408, Bell Gardens

Teva Investigational Site 10425, Carmichael

Teva Investigational Site 10390, Cerritos

Teva Investigational Site 10429, El Cajon

Teva Investigational Site 10423, Escondido

Teva Investigational Site 10391, Huntington Park

Teva Investigational Site 10370, Los Angeles

Teva Investigational Site 10392, Sherman Oaks

Teva Investigational Site 10398, Thousand Oaks

Teva Investigational Site 10428, Torrance

Teva Investigational Site 10361, Walnut Creek

Teva Investigational Site 10369, DeLand

Teva Investigational Site 10379, Fort Lauderdale

Teva Investigational Site 10365, Jacksonville

Teva Investigational Site 10445, Leesburg

Teva Investigational Site 10362, Orlando

Teva Investigational Site 10381, Ormond Beach

Teva Investigational Site 10357, Plantation

Teva Investigational Site 10435, Royal Palm Beach

Teva Investigational Site 10432, Columbus

Teva Investigational Site 10383, Marietta

Teva Investigational Site 10385, Marietta

Teva Investigational Site 10444, Newnan

Teva Investigational Site 10431, Meridian

Teva Investigational Site 10743, Meridian

Teva Investigational Site 10411, Chicago

Teva Investigational Site 10440, Newburgh

Teva Investigational Site 10419, New Orleans

Teva Investigational Site 10359, Shreveport

Teva Investigational Site 10389, Fall River

Teva Investigational Site 10388, Bay City

Teva Investigational Site 10397, Biloxi

Teva Investigational Site 10406, Hazelwood

Teva Investigational Site 10401, St Louis

Teva Investigational Site 10376, Omaha

Teva Investigational Site 10399, Las Vegas

Teva Investigational Site 10409, Berlin

Teva Investigational Site 10439, Buffalo

Teva Investigational Site 10410, New York

Teva Investigational Site 10414, Winston-Salem

Teva Investigational Site 10446, Oklahoma City

Teva Investigational Site 10430, Duncansville

Teva Investigational Site 10386, Mechanicsburg

Teva Investigational Site 10373, Tipton

Teva Investigational Site 10405, Austin

Teva Investigational Site 10364, Dallas

Teva Investigational Site 10372, Dallas

Teva Investigational Site 10371, Houston

Teva Investigational Site 10377, Lake Jackson

Teva Investigational Site 10374, Plano

Teva Investigational Site 10378, San Antonio

Teva Investigational Site 10402, Salt Lake City

Teva Investigational Site 10420, Bellevue

Teva Investigational Site 10433, Everett

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT01922739 - Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets | Biotech Hunter | Biotech Hunter