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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydrocodone ER
Placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, hydrocodone bitartrate, opioids

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must have participated in and completed the entire double-blind treatment period on study drug through the final study visit (week 12) of study 3103.

    NOTE: Patients who had a final on-treatment visit (i.e. prior to week 12) 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.

Sites / Locations

  • Teva Investigational Site 10412
  • Teva Investigational Site 10426
  • Teva Investigational Site 10436
  • Teva Investigational Site 10363
  • Teva Investigational Site 10366
  • Teva Investigational Site 10437
  • Teva Investigational Site 10358
  • Teva Investigational Site 10408
  • Teva Investigational Site 10425
  • Teva Investigational Site 10390
  • Teva Investigational Site 10429
  • Teva Investigational Site 10423
  • Teva Investigational Site 10391
  • Teva Investigational Site 10370
  • Teva Investigational Site 10392
  • Teva Investigational Site 10398
  • Teva Investigational Site 10428
  • Teva Investigational Site 10361
  • Teva Investigational Site 10369
  • Teva Investigational Site 10379
  • Teva Investigational Site 10365
  • Teva Investigational Site 10445
  • Teva Investigational Site 10362
  • Teva Investigational Site 10381
  • Teva Investigational Site 10357
  • Teva Investigational Site 10435
  • Teva Investigational Site 10432
  • Teva Investigational Site 10383
  • Teva Investigational Site 10385
  • Teva Investigational Site 10444
  • Teva Investigational Site 10431
  • Teva Investigational Site 10743
  • Teva Investigational Site 10411
  • Teva Investigational Site 10440
  • Teva Investigational Site 10419
  • Teva Investigational Site 10359
  • Teva Investigational Site 10389
  • Teva Investigational Site 10388
  • Teva Investigational Site 10397
  • Teva Investigational Site 10406
  • Teva Investigational Site 10401
  • Teva Investigational Site 10376
  • Teva Investigational Site 10399
  • Teva Investigational Site 10409
  • Teva Investigational Site 10439
  • Teva Investigational Site 10410
  • Teva Investigational Site 10414
  • Teva Investigational Site 10446
  • Teva Investigational Site 10430
  • Teva Investigational Site 10386
  • Teva Investigational Site 10373
  • Teva Investigational Site 10405
  • Teva Investigational Site 10364
  • Teva Investigational Site 10372
  • Teva Investigational Site 10371
  • Teva Investigational Site 10377
  • Teva Investigational Site 10374
  • Teva Investigational Site 10378
  • Teva Investigational Site 10402
  • Teva Investigational Site 10420
  • Teva Investigational Site 10433

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydrocodone ER

Arm Description

Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.

Outcomes

Primary Outcome Measures

Participants With Adverse Events
An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values. Significance criteria: Blood urea nitrogen: >=10.71 mmol/L Creatinine: >=177 μmol/L Uric acid: M>=625, F>=506 μmol/L Aspartate aminotransferase (AST): >=3* upper limit of normal (ULN) Alkaline phosphatase: >=3* upper limit of normal (ULN) Gamma-glutamyl transpeptidase (GGT): >=3* upper limit of normal (ULN) Serum white blood cells: >=20 * 10^9/L Hemoglobin: M<=115, F<=95 g/dL Hematocrit: M<0.37, F<0.32 L/L Eosinophils: >=10.0 % Platelets: <=75 * 10^9/L Absolute neutrophils: <=1.0 * 10^9/L Urinalysis: Glucose, Ketones, and Total Protein: >=2 unit increase from baseline
Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Data represents participants with potentially clinically significant (PCS) vital sign values. Significance criteria Pulse - high: >=120 and increase of >= 15 beats/minute from baseline Pulse - low: <=50 and decrease of >=15 beats/minute Systolic blood pressure - high: >=180 and increase >=20 mmHg Systolic blood pressure - low: <=90 and decrease >=20 mmHg Diastolic blood pressure - high: >=105 and increase of >=15 mmHg Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg
Participants With Shifts From Normal to Abnormal in Physical Examination Findings
The endpoint visit or early termination visit was an abbreviated exam. Endpoint refers to the last observation carried forward.
Shifts From Baseline to Endpoint (Treatment Period) in Electrocardiogram (ECG) Findings
A 12-lead ECG was conducted at the final visit for study 3103 which is used as baseline for this study, and at week 22 of the treatment period [or early termination]). A qualified physician at the study center was responsible for providing interpretation of the ECG. Endpoint refers to the last observation carried forward.
Participants With Clinically Significant (CS) Hearing Changes From Baseline to the Final Visit in Pure Tone Audiometry Test Results
Pure tone audiometry was performed by trained personnel. Hearing loss was classified in degrees of hearing from normal to profound. This classification was determined by the hearing threshold (or the softest sound detected at a specific frequency). The exact ranges that classified hearing loss depended on the exact technique used during testing and on the patient's age. These values were provided by each audiology laboratory that performed the test. For serial audiograms, the criteria for a clinically significant hearing change were based on guidance from the American Speech Language Hearing Association (ASHA 1994, cited in [Konrad-Martin et al 2005]). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to "no response" at 3 consecutive test frequencies.

Secondary Outcome Measures

Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit
The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. At each visit, participants selected the number that best described their worst pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control. Endpoint refers to the last observation carried forward.
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit
The API was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their average pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control. Endpoint refers to the last observation carried forward.
Percentage of Participants Withdrawn From the Study For Lack of Efficacy
Percentage of patients who withdrew from the study for lack of efficacy, as indicated on the early termination form of the case report form (CRF).

Full Information

First Posted
August 12, 2013
Last Updated
November 6, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01922739
Brief Title
Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe chronic low back pain who require continuous opioid treatment for an extended period of time. To be eligible for Study 3104, patients were required to have completed the entire double blind treatment period on study drug (either placebo or hydrocodone bitartrate ER tablets) through week 12 of Study 3103 (NCT01789970) and to have met the entry criteria for Study 3104.
Detailed Description
Eligible patients from Study 3103 (NCT01789970) were enrolled for participation in this extension study. For these patients, the final study visit in Study 3103 was visit 1 for this study (also referred to as the titration or adjustment baseline visit, depending on whether the patient was enrolled under the original or amended protocol, respectively). The original protocol was amended after 26 patients had been enrolled in the study. Those who were enrolled under the original protocol participated in a double-blind titration period of up to approximately 4 weeks followed by an open-label treatment period of 22 weeks. Those patients who were enrolled under the amended protocol participated in an open-label adjustment period of up to approximately 3 weeks followed by an open-label treatment period of 22 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, hydrocodone bitartrate, opioids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrocodone ER
Arm Type
Experimental
Arm Description
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
Intervention Type
Drug
Intervention Name(s)
Hydrocodone ER
Other Intervention Name(s)
CEP-33237, Hydrocodone bitartrate extended-release tablets
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants With Adverse Events
Description
An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time Frame
Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)
Title
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Description
Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values. Significance criteria: Blood urea nitrogen: >=10.71 mmol/L Creatinine: >=177 μmol/L Uric acid: M>=625, F>=506 μmol/L Aspartate aminotransferase (AST): >=3* upper limit of normal (ULN) Alkaline phosphatase: >=3* upper limit of normal (ULN) Gamma-glutamyl transpeptidase (GGT): >=3* upper limit of normal (ULN) Serum white blood cells: >=20 * 10^9/L Hemoglobin: M<=115, F<=95 g/dL Hematocrit: M<0.37, F<0.32 L/L Eosinophils: >=10.0 % Platelets: <=75 * 10^9/L Absolute neutrophils: <=1.0 * 10^9/L Urinalysis: Glucose, Ketones, and Total Protein: >=2 unit increase from baseline
Time Frame
End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)
Title
Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Description
Data represents participants with potentially clinically significant (PCS) vital sign values. Significance criteria Pulse - high: >=120 and increase of >= 15 beats/minute from baseline Pulse - low: <=50 and decrease of >=15 beats/minute Systolic blood pressure - high: >=180 and increase >=20 mmHg Systolic blood pressure - low: <=90 and decrease >=20 mmHg Diastolic blood pressure - high: >=105 and increase of >=15 mmHg Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg
Time Frame
Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)
Title
Participants With Shifts From Normal to Abnormal in Physical Examination Findings
Description
The endpoint visit or early termination visit was an abbreviated exam. Endpoint refers to the last observation carried forward.
Time Frame
End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)
Title
Shifts From Baseline to Endpoint (Treatment Period) in Electrocardiogram (ECG) Findings
Description
A 12-lead ECG was conducted at the final visit for study 3103 which is used as baseline for this study, and at week 22 of the treatment period [or early termination]). A qualified physician at the study center was responsible for providing interpretation of the ECG. Endpoint refers to the last observation carried forward.
Time Frame
Baseline (final visit for study 3103), End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)
Title
Participants With Clinically Significant (CS) Hearing Changes From Baseline to the Final Visit in Pure Tone Audiometry Test Results
Description
Pure tone audiometry was performed by trained personnel. Hearing loss was classified in degrees of hearing from normal to profound. This classification was determined by the hearing threshold (or the softest sound detected at a specific frequency). The exact ranges that classified hearing loss depended on the exact technique used during testing and on the patient's age. These values were provided by each audiology laboratory that performed the test. For serial audiograms, the criteria for a clinically significant hearing change were based on guidance from the American Speech Language Hearing Association (ASHA 1994, cited in [Konrad-Martin et al 2005]). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to "no response" at 3 consecutive test frequencies.
Time Frame
Baseline was within two weeks of the final study visit in study 3103; during study exam was within two weeks of the end of trial visit for study 3104 (up to study week 26)
Secondary Outcome Measure Information:
Title
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit
Description
The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. At each visit, participants selected the number that best described their worst pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control. Endpoint refers to the last observation carried forward.
Time Frame
Baseline (Day 0 of Treatment Period), Weeks 2, 6, 10, 14, 18, 22 and Endpoint during the Open-Label Treatment Period
Title
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit
Description
The API was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their average pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control. Endpoint refers to the last observation carried forward.
Time Frame
Baseline (Day 0 of Treatment Period), Weeks 2, 6, 10, 14, 18, 22 and Endpoint during the Open-Label Treatment Period
Title
Percentage of Participants Withdrawn From the Study For Lack of Efficacy
Description
Percentage of patients who withdrew from the study for lack of efficacy, as indicated on the early termination form of the case report form (CRF).
Time Frame
Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have participated in and completed the entire double-blind treatment period on study drug through the final study visit (week 12) of study 3103. NOTE: Patients who had a final on-treatment visit (i.e. prior to week 12) are not permitted to participate in study 3104. 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. 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. 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. 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: 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. The patient has current evidence of alcohol or other substance abuse with the exception of nicotine or caffeine. 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. The patient is expected to have surgery during the study. The patient is pregnant or lactating. The patient has developed an active malignancy (excluding basal cell carcinoma) during study 3103. The patient has known human immunodeficiency virus (HIV). 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. The patient has developed cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with opioids. The patient is receiving a monoamine oxidase inhibitor (MAOI). Other exclusion criteria apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 10412
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Teva Investigational Site 10426
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Teva Investigational Site 10436
City
Montgomery
State/Province
Alabama
Country
United States
Facility Name
Teva Investigational Site 10363
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Teva Investigational Site 10366
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Teva Investigational Site 10437
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Teva Investigational Site 10358
City
Anaheim
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10408
City
Bell Gardens
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10425
City
Carmichael
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10390
City
Cerritos
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10429
City
El Cajon
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10423
City
Escondido
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10391
City
Huntington Park
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10370
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10392
City
Sherman Oaks
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10398
City
Thousand Oaks
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10428
City
Torrance
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10361
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10369
City
DeLand
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10379
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10365
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10445
City
Leesburg
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10362
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10381
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10357
City
Plantation
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10435
City
Royal Palm Beach
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10432
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10383
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10385
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10444
City
Newnan
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10431
City
Meridian
State/Province
Idaho
Country
United States
Facility Name
Teva Investigational Site 10743
City
Meridian
State/Province
Idaho
Country
United States
Facility Name
Teva Investigational Site 10411
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Teva Investigational Site 10440
City
Newburgh
State/Province
Indiana
Country
United States
Facility Name
Teva Investigational Site 10419
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Teva Investigational Site 10359
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Teva Investigational Site 10389
City
Fall River
State/Province
Massachusetts
Country
United States
Facility Name
Teva Investigational Site 10388
City
Bay City
State/Province
Michigan
Country
United States
Facility Name
Teva Investigational Site 10397
City
Biloxi
State/Province
Mississippi
Country
United States
Facility Name
Teva Investigational Site 10406
City
Hazelwood
State/Province
Missouri
Country
United States
Facility Name
Teva Investigational Site 10401
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Teva Investigational Site 10376
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Teva Investigational Site 10399
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Teva Investigational Site 10409
City
Berlin
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 10439
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10410
City
New York
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10414
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10446
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Teva Investigational Site 10430
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 10386
City
Mechanicsburg
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 10373
City
Tipton
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 10405
City
Austin
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10364
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10372
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10371
City
Houston
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10377
City
Lake Jackson
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10374
City
Plano
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10378
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10402
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Teva Investigational Site 10420
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Teva Investigational Site 10433
City
Everett
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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