Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

625

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Low Back Pain
Interventions
DRUG

Hydrocodone ER

"During the open-label, titration period, all participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.~Hydrocodone ER was taken by participants randomized to the hydrocodone ER treatment arm during the double-blind treatment period at the dose level identified during the titration period.~Participants were instructed to take tablets with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating."

DRUG

Placebo

"Placebo matching the active drug dose identified during the titration period was taken by participants randomized to the placebo treatment arm during the double-blind treatment period.~Participants were instructed to take intervention with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating."

Trial Locations (87)

Unknown

Teva Investigational Site 10416, Anniston

Teva Investigational Site 10382, Birmingham

Teva Investigational Site 10403, Birmingham

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 10740, Garden Grove

Teva Investigational Site 10391, Huntington Park

Teva Investigational Site 10422, La Jolla

Teva Investigational Site 10413, Laguna Hills

Teva Investigational Site 10442, Laguna Hills

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 10441, Waterbury

Teva Investigational Site 10369, DeLand

Teva Investigational Site 10744, Edgewater

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 12036, Pembroke Pines

Teva Investigational Site 10357, Plantation

Teva Investigational Site 10367, Royal Palm Beach

Teva Investigational Site 10435, Royal Palm Beach

Teva Investigational Site 10742, Sanford

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 10418, Avon

Teva Investigational Site 10380, Evansville

Teva Investigational Site 10440, Newburgh

Teva Investigational Site 10375, Overland Park

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 10396, Omaha

Teva Investigational Site 10417, Henderson

Teva Investigational Site 10399, Las Vegas

Teva Investigational Site 10409, Berlin

Teva Investigational Site 10439, Buffalo

Teva Investigational Site 10394, New York

Teva Investigational Site 10407, New York

Teva Investigational Site 10410, New York

Teva Investigational Site 10443, Raleigh

Teva Investigational Site 10414, Winston-Salem

Teva Investigational Site 10446, Oklahoma City

Teva Investigational Site 10415, Altoona

Teva Investigational Site 10430, Duncansville

Teva Investigational Site 10386, Mechanicsburg

Teva Investigational Site 10373, Tipton

Teva Investigational Site 10404, North Charleston

Teva Investigational Site 10741, Spartanburg

Teva Investigational Site 10405, Austin

Teva Investigational Site 10364, Dallas

Teva Investigational Site 10372, Dallas

Teva Investigational Site 10395, Dallas

Teva Investigational Site 10371, Houston

Teva Investigational Site 12035, 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 10438, Roanoke

Teva Investigational Site 10420, Bellevue

Teva Investigational Site 10433, Everett

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT01789970 - Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain | Biotech Hunter | Biotech Hunter