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



Status:Completed
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:July 2013
End Date:September 2014

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

A 6-Month, Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours for Relief of Moderate to Severe Pain in Patients With Chronic Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety
of hydrocodone bitartrate extended-release tablets in patients with moderate to severe
chronic low back pain who require continuous opioid treatment for an extended period of
time.


Inclusion Criteria:

1. Patients must have participated in and completed the entire double-blind treatment
period on study drug through the final study visit (visit 12) of study 3103. NOTE:
Patients who had a final on-treatment visit (visit 11.5) are not permitted to
participate in study 3104.

2. The patient is able to speak English and is willing to provide written informed
consent for study 3104, including re-signing a written opioid agreement, to
participate in this study.

3. Women of childbearing potential (not surgically sterile or 2 years postmenopausal)
must use a medically accepted method of contraception, agree to continue use of this
method for the duration of the study and for 30 days after participation in the
study, and have a negative pregnancy test at screening. Acceptable methods of
contraception include barrier method with spermicide, intrauterine device (IUD), or
steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction
with a barrier method. NOTE: A woman will be considered surgically sterile if she has
had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral
oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy.

4. The patient must be willing and able to successfully self-administer the study drug,
comply with study restrictions, and return to the study center for scheduled study
visits, as specified in the protocol.

5. The patient must not participate in any other study involving an investigational
agent (excluding those who participated in study 3103) while enrolled in the present
study.

Exclusion Criteria:

1. The patient's current source of pain is different from the low back pain the patient
was experiencing at entry into study 3103. NOTE: Any additional source of pain for a
patient must be discussed with the medical monitor.

2. The patient has current evidence of alcohol or other substance abuse with the
exception of nicotine or caffeine.

3. The patient has developed, during study 3103, a medical or psychiatric disease
(including suicidality) that, in the opinion of the investigator, would compromise
collected data.

4. The patient is expected to have surgery during the study.

5. The patient is pregnant or lactating.

6. The patient has developed an active malignancy (excluding basal cell carcinoma)
during study 3103.

7. The patient has known human immunodeficiency virus (HIV).

8. In the judgment of the investigator, the patient has any clinically significant
deviation from normal in the physical examination and/or clinical laboratory test
values.

9. The patient has developed cardiopulmonary disease that would, in the opinion of the
investigator, significantly increase the risk of treatment with opioids.

10. The patient is receiving a monoamine oxidase inhibitor (MAOI).

- Other exclusion criteria apply.
We found this trial at
71
sites
St. Louis, Missouri
1573
mi
from 91732
St. Louis, MO
Click here to add this to my saved trials
Anaheim, California
17
mi
from 91732
Anaheim, CA
Click here to add this to my saved trials
?
mi
from 91732
Austin, TX
Click here to add this to my saved trials
Bay City, Michigan
1934
mi
from 91732
Bay City, MI
Click here to add this to my saved trials
Bell Gardens, California
270
mi
from 91732
Bell Gardens, CA
Click here to add this to my saved trials
Bellevue, Washington
960
mi
from 91732
Bellevue, WA
Click here to add this to my saved trials
Berlin, New Jersey
2388
mi
from 91732
Berlin, NJ
Click here to add this to my saved trials
Biloxi, Mississippi
1715
mi
from 91732
Biloxi, MS
Click here to add this to my saved trials
Birmingham, Alabama
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2180
mi
from 91732
Buffalo, NY
Click here to add this to my saved trials
Carmichael, California
364
mi
from 91732
Carmichael, CA
Click here to add this to my saved trials
Cerritos, California
15
mi
from 91732
Cerritos, CA
Click here to add this to my saved trials
Chicago, Illinois
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1902
mi
from 91732
Columbus, GA
Click here to add this to my saved trials
1224
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1224
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1224
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
?
mi
from 91732
DeLand, FL
Click here to add this to my saved trials
Duncansville, Pennsylvania
?
mi
from 91732
Duncansville, PA
Click here to add this to my saved trials
El Cajon, California
?
mi
from 91732
El Cajon, CA
Click here to add this to my saved trials
Escondido, California
84
mi
from 91732
Escondido, CA
Click here to add this to my saved trials
Everett, Washington
984
mi
from 91732
Everett, WA
Click here to add this to my saved trials
Everett, Washington
984
mi
from 91732
Everett, WA
Click here to add this to my saved trials
Fall River, Massachusetts
2576
mi
from 91732
Fall River, MA
Click here to add this to my saved trials
Fort Lauderdale, Florida
?
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
Hazelwood, Missouri
1564
mi
from 91732
Hazelwood, MO
Click here to add this to my saved trials
Houston, Texas 77054
1358
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Huntington Park, California
13
mi
from 91732
Huntington Park, CA
Click here to add this to my saved trials
Jacksonville, Florida
2130
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Lake Jackson, Texas
1371
mi
from 91732
Lake Jackson, TX
Click here to add this to my saved trials
Las Vegas, Nevada
217
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
2149
mi
from 91732
Leesburg, FL
Click here to add this to my saved trials
Los Angeles, California
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from 91732
Marietta, GA
Click here to add this to my saved trials
?
mi
from 91732
Marietta, GA
Click here to add this to my saved trials
Mechanicsburg, Pennsylvania
2277
mi
from 91732
Mechanicsburg, PA
Click here to add this to my saved trials
664
mi
from 91732
Meridian, ID
Click here to add this to my saved trials
664
mi
from 91732
Meridian, ID
Click here to add this to my saved trials
1757
mi
from 91732
Mobile, AL
Click here to add this to my saved trials
Montgomery, Alabama 36116
1833
mi
from 91732
Montgomery, AL
Click here to add this to my saved trials
New Orleans, Louisiana
1655
mi
from 91732
New Orleans, LA
Click here to add this to my saved trials
New Orleans, Louisiana
1655
mi
from 91732
New Orleans, LA
Click here to add this to my saved trials
New York, New York
2432
mi
from 91732
New York, NY
Click here to add this to my saved trials
New York, New York
2432
mi
from 91732
New York, NY
Click here to add this to my saved trials
New York, New York
2432
mi
from 91732
New York, NY
Click here to add this to my saved trials
1723
mi
from 91732
Newburgh, IN
Click here to add this to my saved trials
1900
mi
from 91732
Newnan, GA
Click here to add this to my saved trials
Oklahoma City, Oklahoma
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
2184
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
Ormond Beach, Florida
2186
mi
from 91732
Ormond Beach, FL
Click here to add this to my saved trials
Phoenix, Arizona
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
1227
mi
from 91732
Plano, TX
Click here to add this to my saved trials
Plantation, Florida
2310
mi
from 91732
Plantation, FL
Click here to add this to my saved trials
Royal Palm Beach, Florida
?
mi
from 91732
Royal Palm Beach, FL
Click here to add this to my saved trials
Royal Palm Beach, Florida
?
mi
from 91732
Royal Palm Beach, FL
Click here to add this to my saved trials
Salt Lake City, Utah
570
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
Sharmon Oaks, California
202
mi
from 91732
Sharmon Oaks, CA
Click here to add this to my saved trials
Shreveport, Louisiana
1401
mi
from 91732
Shreveport, LA
Click here to add this to my saved trials
Thousand Oaks, California
47
mi
from 91732
Thousand Oaks, CA
Click here to add this to my saved trials
Tipton, Pennsylvania
2208
mi
from 91732
Tipton, PA
Click here to add this to my saved trials
Torrance, California
?
mi
from 91732
Torrance, CA
Click here to add this to my saved trials
426
mi
from 91732
Tucson, AZ
Click here to add this to my saved trials
Walnut Creek, California
347
mi
from 91732
Walnut Creek, CA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
2123
mi
from 91732
Winston-Salem, NC
Click here to add this to my saved trials