Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain



Status:Completed
Conditions:Back Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2010
End Date:July 2011

Use our guide to learn which trials are right for you!

A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain

The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal
film is effective and safe in the treatment of chronic low back pain (CLBP).

This is an enriched enrollment, randomized withdrawal study with an open label,
dose-titration period followed by a randomized, double-blind, placebo-controlled treatment
period of 12 weeks. During the double-blind treatment period, this study will evaluate the
effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP
in subjects.

Buprenorphine HCl buccal film is an oral transmucosal form of the opioid analgesic,
buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is
a synthetic opioid that is classified as a partial µ-receptor agonist and a Schedule III
controlled substance in the United States.

Inclusion Criteria:

- Male or non-pregnant and non-nursing female aged 18 or older

- History of moderate to severe chronic low back pain for ≥3 months with a pain
intensity ≥5 [11 point numerical rating scale] reported at the open-label titration
period Day 0/1 visit following a washout period (opioids, nonsteroidal
anti-inflammatory drugs [NSAIDs], and muscle relaxants) of approximately 12 to 24
hours

- Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid
(including opioid naïve) for 1 week or longer

- Stable health, as determined by the Investigator, on the basis of medical history,
physical examination, and screening laboratory results so as to comply with all study
procedures

- Female subjects of childbearing potential must be using a recognized effective method
of birth control

- Written informed consent obtained at Screening, prior to any procedure being
performed

Exclusion Criteria:

- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute
spinal cord compression, cauda equina compression, acute nerve root compression,
meningitis, and discitis

- Surgical procedure for back pain within 2 months prior to screening or nerve/plexus
block within 4 weeks of screening

- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial
fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active
myocardial ischemia

- Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram
(ECG)

- History of long QT syndrome, or an immediate family member with this condition

- Diagnosis of moderate to severe hepatic impairment.

- History of severe emesis with opioids

- Clinically significant sleep apnea
We found this trial at
24
sites
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
?
mi
from
DeLand, FL
Click here to add this to my saved trials
3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
1402 Ninth Avenue
Altoona, Pennsylvania 16602
814-940-2000
?
mi
from
Altoona, PA
Click here to add this to my saved trials
736 E Bullard Ave
Fresno, California 93710
559-437-9700
?
mi
from
Fresno, CA
Click here to add this to my saved trials
3838 South 700 East
Salt Lake City, Utah 84106
801-269-8200
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Austin, Texas 78703
?
mi
from
Austin, TX
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bloomington, Illinois 61701
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
El Paso, Texas 79902
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Jupiter, Florida 33458
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89144
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Leawood, KS
Click here to add this to my saved trials
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Mobile, Alabama 36608
?
mi
from
Mobile, AL
Click here to add this to my saved trials
New York, New York 10022
?
mi
from
New York, NY
Click here to add this to my saved trials
Phoenix, Arizona 85023
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Plantation, Florida 33317
?
mi
from
Plantation, FL
Click here to add this to my saved trials
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Watertown, Massachusetts 02472
?
mi
from
Watertown, MA
Click here to add this to my saved trials
West Jordan, Utah 84088
?
mi
from
West Jordan, UT
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials