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Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydrocodone ER
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 Chronic Pain focused on measuring moderate to severe pain, diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, osteoarthritis, rheumatoid arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, and return to the clinic for scheduled study visits as specified in this protocol.
  • The patient has either completed Cephalon study 3079 or has chronic pain of at least 3 months duration prior to entering this study associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, osteoarthritis, or rheumatoid arthritis. Patients with other painful conditions may qualify for the study with permission from the Cephalon medical monitor or designee.
  • Those patients who completed the 12-week, double-blind, placebo-controlled, randomized study (study 3079) and are willing to re-titrate study drug to an effective dose of hydrocodone extended-release tablets are eligible to enter this study.
  • The patient is able to speak English, willing to provide written informed consent, and sign a written opioid agreement, to participate in this study.
  • The patient is 18 through 80 years of age (inclusive) at the time of entering this or the previous study (study 3079).
  • Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must 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.

Exclusion Criteria:

  • Patients who were enrolled in study 3079 but did not complete the 12-week, double-blind, placebo-controlled, randomized study may not be enrolled into this study.
  • The patient has known or suspected hypersensitivities, allergies, or other contraindications to the study drug or its excipients.
  • The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
  • The patient has a medical or psychiatric condition/disease that, in the opinion of the investigator, would compromise collected data.
  • The patient is taking a total (i.e., including around-the clock [ATC] and rescue medications) of more than 135 mg/day of oxycodone or equivalent for 14 days prior to screening.
  • The patient has a history of suicidality.
  • The patient has a diagnosis of chronic headache or migraine as the primary painful condition under study.
  • The patient is expected to have surgery during the study and it is anticipated that the surgery will alleviate the patient's pain.
  • The patient is pregnant or lactating.
  • The patient has active malignancy.
  • The patient has 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 cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids.
  • The patient has participated in a study involving an investigational drug in the previous 30 days (excluding those who participated in study 3079).
  • The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
  • The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.
  • The patient is involved in active litigation in regard to the chronic pain currently being treated.
  • The patient has a positive urine drug screen (UDS) for an illicit substance or medication not prescribed by the physician currently treating the chronic pain.
  • The investigator feels that the patient is not suitable for the study.

Sites / Locations

  • Horizon Research Group, LLC
  • Physician Alliance Research Center
  • Adam D. Karns, MD
  • Associated Pharmaceutical Research Center, Inc.
  • Providence Clinical Research
  • Research Center of Fresno, Inc.
  • Pacific Coast Pain Management Center
  • South Orange County Surgical Medical Group
  • Accelovance, Inc.
  • Bayview Research Group, LLC
  • Clinical Research of West Florida, Inc.
  • Avail Clinical Research, LLC
  • Compass Research, LLC
  • Sarasota Pain Medicine Research LLC
  • Gold Coast Research LLC
  • Drug Studies America
  • Georgia Institute for Clinical Research, LLC
  • Taylor Research, LLC
  • Better Health Clinical Research, Inc.
  • Millennium Pain Center
  • Rehabilitation Associates of Indiana
  • International Clinical Research, Inc.
  • Community Research
  • Willis Knighton River Cities Clinical Research Center
  • MidAtlantic Pain Medicine Center
  • Beacon Clinical Research, LLC
  • HealthCare Research
  • Sundance Clinical Research, LLC
  • Meridian Clinical Research
  • Clinical Research Center of Nevada
  • Advanced Pain Consultants
  • Upstate Clinical Research Associates
  • Wake Research Associates
  • Sterling Research Group, Ltd.
  • Columbus Clinical Research
  • SP Research
  • Pain Research of Oregon
  • Summit Research Network Inc.
  • Brandywine Clinical Research
  • AMH Feasterville Family Health Care Center
  • Tipton Medical and Diagnostic Center
  • Clinical Research Center of Reading, LLP
  • Omega Medical Research
  • Greenville Pharmaceutical Research
  • Trident Institute of Medical Research, LLC
  • S. Carolina Pharmaceutical Research
  • KRK Medical Research
  • Radiant Research
  • Renaissance Clinical Research & Hypertension of Texas, PLLC
  • Medstar Clinical Research
  • Benchmark Research
  • DCT-Sugarland, LLC dba Discovery Clinical Trials
  • Hillcrest Family Health Centers
  • Aspen Clinical Research, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydrocodone ER

Arm Description

Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg orally every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at the successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.

Outcomes

Primary Outcome Measures

Participants With Adverse Experiences
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. 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 (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
Data represents participants with PCS abnormal serum chemistry, hematology and urinalysis values. Significance criteria: alanine aminotransferase (ALT): >=3 times the upper limit of normal (ULN). Normal range is 6-43 U/L aspartate aminotransferase (AST): >=3 times ULN. Normal range is 9-36 U/L blood urea nitrogen (BUN): >=10.71 mmol/L creatinine: >=177 μmol/L uric acid: M>=625, F>=506 μmol/L white blood cell count: <=3.0*10^9/L hemoglobin: M<=115, F<=95 g/dL hematocrit: M<0.37, F<0.32 L/L urine blood (hemoglobin): >=2 unit increase from baseline urine glucose: >=2 unit increase from baseline
Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status
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
Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status
A 12-lead ECG was conducted at screening, week 24, and week 52 or at the last postbaseline observation. For rollover participants, the ECG performed at the final visit of study 3079 served as the 1st ECG in study 3080. A qualified physician was responsible for interpreting the ECG. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared with baseline was considered an adverse event. For overall results, the worst postbaseline finding for the participant was summarized. Results below are formatted as Baseline ECG result - Overall ECG result.
Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status
Pure tone audiometry was performed by trained personnel. During the test, the patient wore headphones and was seated in a quiet room; trained personnel manipulated the audiometry equipment to test the patient's hearing. For serial audiograms, the criteria for a clinically significant (CS) hearing change were based on the guidance from the American Speech-Language Hearing Association (ASHA) 1994 (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

Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
The PGA of the method of pain control consisted of a asking patients a single question to assess their method of pain control during the previous 24 hours as either poor, fair, good, or excellent (Rothman et al 2009).
Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain - Revised (SOAPP-R)
SOAPP-R is a clinician-rated scale used to assess each patient's risk of developing aberrant drug use behaviors while on long term opioid therapy. SOAPP-R consists of 24 questions that address 8 concepts: substance abuse history, medication related behaviors, antisocial behaviors/history, psychosocial problems, psychiatric history, physician patient relationship factors, emotional attachment to pain medications, and personal care and lifestyle issues (Butler et al 2008). Each question is answered using a 5 point Likert-like scale, with 0=never, 1=seldom, 2=sometimes, 3=often, and 4=very often for a total range of 0-96. The higher the overall score, the greater the probability the patient is at risk for displaying aberrant behaviors consistent with drug use. An overall score of 18 or higher is considered positive for predicting aberrant drug related behavior, therefore the reported risk categories are <18 and <=18. Results indicate timeframe followed by risk cat
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
The ABC was a clinician rated scale that consisted of a brief (21 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as 1 point, and points were added to calculate the total score. All but 1 of the 21 items (the provider's impression) was used in calculating the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen). Participants with a total score of 3 or greater were classified as exhibiting inappropriate opioid use during the study.
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
The COMM was a clinician-rated scale developed as a brief self-report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long-term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior.

Full Information

First Posted
October 15, 2010
Last Updated
May 2, 2017
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01223365
Brief Title
Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time
Official Title
A 12-Month, Open-Label Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours in Patients Who Require Opioid Treatment for an Extended Period of Time
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (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
The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.
Detailed Description
This was a Phase 3, open-label, nonrandomized study that consisted of a screening period, an open label titration period, and a 52 week, long term, open-label treatment period in patients with chronic pain. Patients were eligible to participate in this study if they had completed study C33237/3079 (NCT01240863) (these patients are hereafter referred to as rollover patients) or if they had not participated in study 3079 (these patients are hereafter referred to as either new opioid naïve or new opioid experienced patients).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
moderate to severe pain, diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, osteoarthritis, rheumatoid arthritis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Hydrocodone ER
Arm Type
Experimental
Arm Description
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg orally every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at the successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
Intervention Type
Drug
Intervention Name(s)
Hydrocodone ER
Other Intervention Name(s)
CEP-33237, Hydrocodone bitartrate extended-release
Intervention Description
Hydrocodone bitartrate extended-release tablets were administered at doses of 15, 30, 45, 60, and 90 mg orally every 12 hours. During the open-label titration period, doses were adjusted until a stable pain control was achieved. In general, the dose of hydrocodone extended release tablets could be adjusted for efficacy or tolerability, as necessary, at any time during the open-label treatment period; however, participants were required to visit the study center before increasing the dose of study drug.
Primary Outcome Measure Information:
Title
Participants With Adverse Experiences
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. 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 open-label titration period - Week 52 of the open-label treatment period
Title
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
Description
Data represents participants with PCS abnormal serum chemistry, hematology and urinalysis values. Significance criteria: alanine aminotransferase (ALT): >=3 times the upper limit of normal (ULN). Normal range is 6-43 U/L aspartate aminotransferase (AST): >=3 times ULN. Normal range is 9-36 U/L blood urea nitrogen (BUN): >=10.71 mmol/L creatinine: >=177 μmol/L uric acid: M>=625, F>=506 μmol/L white blood cell count: <=3.0*10^9/L hemoglobin: M<=115, F<=95 g/dL hematocrit: M<0.37, F<0.32 L/L urine blood (hemoglobin): >=2 unit increase from baseline urine glucose: >=2 unit increase from baseline
Time Frame
Day 1 - Week 52 of the open-label treatment period
Title
Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status
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 open-label titration period - Week 52 of the open-label treatment period
Title
Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status
Description
A 12-lead ECG was conducted at screening, week 24, and week 52 or at the last postbaseline observation. For rollover participants, the ECG performed at the final visit of study 3079 served as the 1st ECG in study 3080. A qualified physician was responsible for interpreting the ECG. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared with baseline was considered an adverse event. For overall results, the worst postbaseline finding for the participant was summarized. Results below are formatted as Baseline ECG result - Overall ECG result.
Time Frame
Baseline for new participants was between Day -7 and -14 (the study 3080 screening visit); baseline for rollover participants was the last ECG in study 3079. During study ECGs were performed on weeks 24 and 52 of the open-label treatment period
Title
Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status
Description
Pure tone audiometry was performed by trained personnel. During the test, the patient wore headphones and was seated in a quiet room; trained personnel manipulated the audiometry equipment to test the patient's hearing. For serial audiograms, the criteria for a clinically significant (CS) hearing change were based on the guidance from the American Speech-Language Hearing Association (ASHA) 1994 (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 for new participants was between Day -7 and -14 (study 3080 screening visit); baseline for rollover participants was the baseline test in study 3079. During study covers both open-label titration and 52-week treatment periods
Secondary Outcome Measure Information:
Title
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Description
The PGA of the method of pain control consisted of a asking patients a single question to assess their method of pain control during the previous 24 hours as either poor, fair, good, or excellent (Rothman et al 2009).
Time Frame
Baseline for new participants was Day 1, i.e. the first day of open-label titration. Baseline for rollover participants was the baseline in study 3079. Week 4 (end of titration, start of open-label treatment), Week 52, last visit up to Week 52
Title
Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain - Revised (SOAPP-R)
Description
SOAPP-R is a clinician-rated scale used to assess each patient's risk of developing aberrant drug use behaviors while on long term opioid therapy. SOAPP-R consists of 24 questions that address 8 concepts: substance abuse history, medication related behaviors, antisocial behaviors/history, psychosocial problems, psychiatric history, physician patient relationship factors, emotional attachment to pain medications, and personal care and lifestyle issues (Butler et al 2008). Each question is answered using a 5 point Likert-like scale, with 0=never, 1=seldom, 2=sometimes, 3=often, and 4=very often for a total range of 0-96. The higher the overall score, the greater the probability the patient is at risk for displaying aberrant behaviors consistent with drug use. An overall score of 18 or higher is considered positive for predicting aberrant drug related behavior, therefore the reported risk categories are <18 and <=18. Results indicate timeframe followed by risk cat
Time Frame
End of Open-label Titration Period. Weeks 4 and 24 of the Open-label Treatment Period
Title
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Description
The ABC was a clinician rated scale that consisted of a brief (21 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as 1 point, and points were added to calculate the total score. All but 1 of the 21 items (the provider's impression) was used in calculating the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen). Participants with a total score of 3 or greater were classified as exhibiting inappropriate opioid use during the study.
Time Frame
Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52
Title
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Description
The COMM was a clinician-rated scale developed as a brief self-report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long-term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior.
Time Frame
Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration Period. Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52

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: The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, and return to the clinic for scheduled study visits as specified in this protocol. The patient has either completed Cephalon study 3079 or has chronic pain of at least 3 months duration prior to entering this study associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, osteoarthritis, or rheumatoid arthritis. Patients with other painful conditions may qualify for the study with permission from the Cephalon medical monitor or designee. Those patients who completed the 12-week, double-blind, placebo-controlled, randomized study (study 3079) and are willing to re-titrate study drug to an effective dose of hydrocodone extended-release tablets are eligible to enter this study. The patient is able to speak English, willing to provide written informed consent, and sign a written opioid agreement, to participate in this study. The patient is 18 through 80 years of age (inclusive) at the time of entering this or the previous study (study 3079). Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must 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. Exclusion Criteria: Patients who were enrolled in study 3079 but did not complete the 12-week, double-blind, placebo-controlled, randomized study may not be enrolled into this study. The patient has known or suspected hypersensitivities, allergies, or other contraindications to the study drug or its excipients. The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse. The patient has a medical or psychiatric condition/disease that, in the opinion of the investigator, would compromise collected data. The patient is taking a total (i.e., including around-the clock [ATC] and rescue medications) of more than 135 mg/day of oxycodone or equivalent for 14 days prior to screening. The patient has a history of suicidality. The patient has a diagnosis of chronic headache or migraine as the primary painful condition under study. The patient is expected to have surgery during the study and it is anticipated that the surgery will alleviate the patient's pain. The patient is pregnant or lactating. The patient has active malignancy. The patient has 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 cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids. The patient has participated in a study involving an investigational drug in the previous 30 days (excluding those who participated in study 3079). The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug. The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data. The patient is involved in active litigation in regard to the chronic pain currently being treated. The patient has a positive urine drug screen (UDS) for an illicit substance or medication not prescribed by the physician currently treating the chronic pain. The investigator feels that the patient is not suitable for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sponsor's Medical Expert, MD
Organizational Affiliation
Cephalon
Official's Role
Study Director
Facility Information:
Facility Name
Horizon Research Group, LLC
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Physician Alliance Research Center
City
Anaheim
State/Province
California
Country
United States
Facility Name
Adam D. Karns, MD
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
Associated Pharmaceutical Research Center, Inc.
City
Buena Park
State/Province
California
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
Country
United States
Facility Name
Research Center of Fresno, Inc.
City
Fresno
State/Province
California
Country
United States
Facility Name
Pacific Coast Pain Management Center
City
Laguna Hills
State/Province
California
Country
United States
Facility Name
South Orange County Surgical Medical Group
City
Laguna Hills
State/Province
California
Country
United States
Facility Name
Accelovance, Inc.
City
San Diego
State/Province
California
Country
United States
Facility Name
Bayview Research Group, LLC
City
Valley Village
State/Province
California
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Sarasota Pain Medicine Research LLC
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Gold Coast Research LLC
City
Weston
State/Province
Florida
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Georgia Institute for Clinical Research, LLC
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Taylor Research, LLC
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Better Health Clinical Research, Inc.
City
Newnan
State/Province
Georgia
Country
United States
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
Country
United States
Facility Name
Rehabilitation Associates of Indiana
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
International Clinical Research, Inc.
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Community Research
City
Crestview Hills
State/Province
Kentucky
Country
United States
Facility Name
Willis Knighton River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
MidAtlantic Pain Medicine Center
City
Pikesville
State/Province
Maryland
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Brockton
State/Province
Massachusetts
Country
United States
Facility Name
HealthCare Research
City
Florissant
State/Province
Missouri
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Advanced Pain Consultants
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Sterling Research Group, Ltd.
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Columbus Clinical Research
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
SP Research
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Pain Research of Oregon
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Brandywine Clinical Research
City
Downingtown
State/Province
Pennsylvania
Country
United States
Facility Name
AMH Feasterville Family Health Care Center
City
Feasterville-Trevose
State/Province
Pennsylvania
Country
United States
Facility Name
Tipton Medical and Diagnostic Center
City
Tipton
State/Province
Pennsylvania
Country
United States
Facility Name
Clinical Research Center of Reading, LLP
City
West Reading
State/Province
Pennsylvania
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Greenville Pharmaceutical Research
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Trident Institute of Medical Research, LLC
City
North Charleston
State/Province
South Carolina
Country
United States
Facility Name
S. Carolina Pharmaceutical Research
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
KRK Medical Research
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Radiant Research
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Renaissance Clinical Research & Hypertension of Texas, PLLC
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Medstar Clinical Research
City
Houston
State/Province
Texas
Country
United States
Facility Name
Benchmark Research
City
San Angelo
State/Province
Texas
Country
United States
Facility Name
DCT-Sugarland, LLC dba Discovery Clinical Trials
City
Sugar Land
State/Province
Texas
Country
United States
Facility Name
Hillcrest Family Health Centers
City
Waco
State/Province
Texas
Country
United States
Facility Name
Aspen Clinical Research, LLC
City
Orem
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time

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