A Phase 3 interventional study of Hydrocodone ER in Chronic Pain, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 54 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-06-05.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 3, Interventional, and Treatment
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.
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).
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 330 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Hydrocodone ER
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.
Also known as: CEP-33237, Hydrocodone bitartrate extended-release
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.
Time frame: Day 1 of open-label titration period - Week 52 of the open-label treatment period
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
Time frame: Day 1 - Week 52 of the open-label treatment period
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
Time frame: Day 1 of open-label titration period - Week 52 of the open-label treatment period
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.
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
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.
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
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).
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
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
Time frame: End of Open-label Titration Period. Weeks 4 and 24 of the Open-label Treatment Period
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.
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
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.
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
365 patients with chronic pain were screened for enrollment into this study: 25 patients were excluded on the basis of exclusion criteria, 6 withdrew consent, 2 were lost to follow up before the baseline visit, 1 patient did not meet an inclusion criteria, and 1 patient had an opioid violation because of self increasing analgesic medication.
| Milestone | Hydrocodone ER |
|---|---|
| Started | 330 |
| Safety analysis set | 329 |
| Achieved stable pain relief | 294 |
| Completed | 291 |
| Not completed | 39 |
| Withdrew: Enrolled but not treated | 1 |
| Withdrew: Adverse event | 23 |
| Withdrew: Lack of efficacy | 3 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Noncompliance with study drug admin | 1 |
| Withdrew: Noncompliance with study procedures | 2 |
| Withdrew: Starting physical therapy | 1 |
| Milestone | Hydrocodone ER |
|---|---|
| Started | 291 |
| Completed | 189 |
| Not completed | 102 |
| Withdrew: Adverse event | 39 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Withdrawal by subject | 19 |
| Withdrew: Protocol violation | 15 |
| Withdrew: Lost to follow-up | 7 |
| Withdrew: Noncompliance with study drug admin | 7 |
| Withdrew: Noncompliance with study procedures | 6 |
| Withdrew: Moved out of area | 2 |
| Withdrew: Negative urine drug screen when on treat | 1 |
| Withdrew: "out of window" | 1 |
| Withdrew: Starting physical therapy | 1 |
| Withdrew: Physician decision | 2 |
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 | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation | Total Hydrocodone ER |
|---|---|---|---|---|
| Any adverse event | 51 | 98 | 135 | 284 |
| Treatment-related adverse event | 41 | 69 | 63 | 173 |
| Death | 0 | 1 | 1 | 2 |
| Serious adverse event | 4 | 16 | 7 | 27 |
| Withdrawals from treatment due to adverse event | 18 | 24 | 20 | 62 |
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 | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation | Total Hydrocodone ER |
|---|---|---|---|---|
| ALT | 0 | 2 | 1 | 3 |
| AST | 0 | 2 | 0 | 2 |
| BUN | 0 | 3 | 5 | 8 |
| Creatinine | 0 | 1 | 1 | 2 |
| Uric acid | 1 | 4 | 3 | 8 |
| White blood cell count | 0 | 1 | 0 | 1 |
| Hemoglobin | 1 | 3 | 3 | 7 |
| Hematocrit | 2 | 6 | 6 | 14 |
| Urine blood | 1 | 4 | 2 | 7 |
| Urine glucose | 2 | 2 | 5 | 9 |
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 | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation | Total Hydrocodone ER |
|---|---|---|---|---|
| Pulse - high | 0 | 2 | 0 | 2 |
| Pulse - low | 1 | 0 | 5 | 6 |
| Systolic blood pressure - high | 1 | 0 | 2 | 3 |
| Systolic blood pressure - low | 0 | 4 | 7 | 11 |
| Diastolic blood pressure - high | 3 | 0 | 3 | 6 |
| Diastolic blood pressure - low | 1 | 2 | 3 | 6 |
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 | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation | Total Hydrocodone ER |
|---|---|---|---|---|
| Normal baseline - Normal overall | 18 | 33 | 43 | 94 |
| Normal baseline - Abnormal overall | 8 | 17 | 35 | 60 |
| Abnormal baseline - Normal overall | 0 | 7 | 18 | 25 |
| Abnormal baseline - Abnormal overall | 15 | 32 | 54 | 101 |
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.
| Participants | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation | Total Hydrocodone ER |
|---|---|---|---|---|
| >=1 CS value during study | 10 | 30 | 36 | 76 |
| >=1 CS value during open-label titration period | 4 | 14 | 4 | 22 |
| >=1 CS value at endpoint | 2 | 8 | 13 | 23 |
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 | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation | Total Hydrocodone ER |
|---|---|---|---|---|
| Baseline: Poor | 18 | 10 | 49 | 77 |
| Baseline: Fair | 14 | 55 | 71 | 140 |
| Baseline: Good | 1 | 18 | 29 | 48 |
| Baseline: Excellent | 1 | 3 | 3 | 7 |
| Week 4: Poor | 2 | 1 | 2 | 5 |
| Week 4: Fair | 5 | 17 | 27 | 49 |
| Week 4: Good | 20 | 54 | 94 | 168 |
| Week 4: Excellent | 13 | 15 | 27 | 55 |
| Week 52: Poor | 0 | 2 | 2 | 4 |
| Week 52: Fair | 3 | 9 | 18 | 30 |
| Week 52: Good | 17 | 36 | 62 | 115 |
| Week 52: Excellent | 8 | 10 | 21 | 39 |
| Endpoint: Poor | 3 | 6 | 8 | 17 |
| Endpoint: Fair (n=42, 92, 157, 291) | 7 | 21 | 27 | 55 |
| Endpoint: Good | 21 | 52 | 93 | 166 |
| Endpoint: Excellent | 11 | 13 | 29 | 53 |
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
| Participants | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation | Total Hydrocodone ER |
|---|---|---|---|---|
| End of Open-Label Titration: >=18 | 0 | 0 | 0 | 0 |
| End of Open-Label Titration: <18 | 0 | 0 | 2 | 2 |
| Week 4: >=18 | 1 | 12 | 3 | 16 |
| Week 4: <18 | 39 | 73 | 134 | 246 |
| Week 24: >=18 | 0 | 0 | 0 | 0 |
| Week 24: <18 | 0 | 0 | 1 | 1 |
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.
| units on a scale | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation | Total Hydrocodone ER |
|---|---|---|---|---|
| Baseline | 0.1 ± 0.40 | 0.1 ± 0.46 | 0.2 ± 0.60 | 0.2 ± 0.53 |
| End of Titration | 0.1 ± 0.22 | 0.0 ± 0.15 | 0.1 ± 0.38 | 0.1 ± 0.31 |
| Week 4 | 0.2 ± 0.43 | 0.2 ± 0.47 | 0.1 ± 0.39 | 0.1 ± 0.42 |
| Week 8 | 0.1 ± 0.41 | 0.2 ± 0.42 | 0.1 ± 0.38 | 0.1 ± 0.40 |
| Week 12 | 0.2 ± 0.51 | 0.2 ± 0.40 | 0.1 ± 0.36 | 0.1 ± 0.39 |
| Week 16 | 0.1 ± 0.34 | 0.1 ± 0.29 | 0.2 ± 0.56 | 0.1 ± 0.47 |
| Week 20 | 0.2 ± 0.46 | 0.1 ± 0.24 | 0.2 ± 0.45 | 0.1 ± 0.40 |
| Week 24 | 0.1 ± 0.26 | 0.1 ± 0.31 | 0.1 ± 0.41 | 0.1 ± 0.36 |
| Week 28 | 0.1 ± 0.41 | 0.1 ± 0.27 | 0.1 ± 0.42 | 0.1 ± 0.38 |
| Week 32 | 0.2 ± 0.60 | 0.0 ± 0.25 | 0.1 ± 0.42 | 0.1 ± 0.41 |
| Week 36 | 0.1 ± 0.59 | 0.1 ± 0.43 | 0.1 ± 0.41 | 0.1 ± 0.44 |
| Week 40 | 0.1 ± 0.31 | 0.1 ± 0.25 | 0.1 ± 0.46 | 0.1 ± 0.38 |
| Week 44 | 0.1 ± 0.26 | 0.1 ± 0.31 | 0.1 ± 0.44 | 0.1 ± 0.38 |
| Week 48 | 0.0 ± 0.19 | 0.0 ± 0.13 | 0.1 ± 0.41 | 0.1 ± 0.32 |
| Week 52 | 0.1 ± 0.45 | 0.1 ± 0.23 | 0.1 ± 0.41 | 0.1 ± 0.37 |
| Endpoint | 0.2 ± 0.52 | 0.2 ± 0.60 | 0.2 ± 0.59 | 0.2 ± 0.58 |
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.
| units on a scale | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation | Total Hydrocodone ER |
|---|---|---|---|---|
| Baseline | 5.1 ± 5.29 | 5.4 ± 4.61 | 3.7 ± 3.70 | 4.4 ± 4.31 |
| End of Titration | 3.8 ± 3.37 | 4.0 ± 3.66 | 2.1 ± 2.74 | 3.0 ± 3.26 |
| Week 4 | 3.2 ± 3.06 | 3.7 ± 3.70 | 2.3 ± 2.83 | 2.9 ± 3.21 |
| Week 8 | 2.4 ± 2.44 | 3.9 ± 4.12 | 2.4 ± 2.96 | 2.8 ± 3.36 |
| Week 12 | 3.1 ± 3.12 | 4.2 ± 3.99 | 2.4 ± 2.71 | 3.1 ± 3.28 |
| Week 16 | 2.4 ± 1.98 | 4.0 ± 4.84 | 2.3 ± 2.82 | 2.9 ± 3.53 |
| Week 20 | 2.6 ± 2.49 | 3.5 ± 3.78 | 2.1 ± 2.80 | 2.6 ± 3.13 |
| Week 24 | 2.6 ± 2.66 | 3.9 ± 4.14 | 2.4 ± 3.04 | 2.9 ± 3.42 |
| Week 28 | 2.1 ± 2.10 | 3.3 ± 3.66 | 2.3 ± 2.91 | 2.6 ± 3.09 |
| Week 32 | 2.3 ± 1.84 | 2.8 ± 3.07 | 2.0 ± 2.62 | 2.3 ± 2.69 |
| Week 36 | 2.9 ± 2.44 | 3.2 ± 3.35 | 2.3 ± 3.30 | 2.7 ± 3.22 |
| Week 40 | 2.8 ± 3.21 | 3.0 ± 3.20 | 2.1 ± 2.97 | 2.5 ± 3.09 |
| Week 44 | 2.3 ± 1.90 | 2.7 ± 2.86 | 2.2 ± 3.41 | 2.4 ± 3.06 |
| Week 48 | 2.4 ± 2.57 | 3.0 ± 3.98 | 2.3 ± 3.19 | 2.5 ± 3.37 |
| Week 52 | 2.4 ± 2.39 | 3.0 ± 3.30 | 2.3 ± 3.05 | 2.5 ± 3.04 |
| Endpoint | 3.5 ± 3.74 | 4.2 ± 4.41 | 2.5 ± 3.25 | 3.2 ± 3.78 |
Collected over Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| New Opioid Naïve Subpopulation | — | 4/52 (7.7%) | 47/52 (90.4%) |
| New Opioid Experienced Subpopulation | — | 16/112 (14.3%) | 83/112 (74.1%) |
| Rollover Subpopulation | — | 7/165 (4.2%) | 109/165 (66.1%) |
| Event | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation |
|---|---|---|---|
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/24 | 1/44 | 0/64 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/52 | 0/112 | 0/165 |
| Cholecystitis acuteHepatobiliary disorders | 1/52 | 0/112 | 0/165 |
| Listeria sepsisInfections and infestations | 1/52 | 0/112 | 0/165 |
| DehydrationMetabolism and nutrition disorders | 1/52 | 1/112 | 0/165 |
| HemiparesisNervous system disorders | 1/52 | 0/112 | 0/165 |
| HypoaesthesiaNervous system disorders | 1/52 | 0/112 | 0/165 |
| Speech disorderNervous system disorders | 1/52 | 0/112 | 0/165 |
| TremorNervous system disorders | 1/52 | 0/112 | 0/165 |
| Impulsive behaviourPsychiatric disorders | 1/52 | 0/112 | 0/165 |
| Event | New Opioid Naïve Subpopulation | New Opioid Experienced Subpopulation | Rollover Subpopulation |
|---|---|---|---|
| ConstipationGastrointestinal disorders | 19/52 | 35/112 | 31/165 |
| NauseaGastrointestinal disorders | 16/52 | 18/112 | 28/165 |
| HeadacheNervous system disorders | 8/52 | 20/112 | 10/165 |
| SomnolenceNervous system disorders | 9/52 | 15/112 | 11/165 |
| VomitingGastrointestinal disorders | 8/52 | 7/112 | 16/165 |
| InfluenzaInfections and infestations | 5/52 | 5/112 | 4/165 |
| Upper respiratory tract infectionInfections and infestations | 5/52 | 6/112 | 15/165 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/52 | 10/112 | 14/165 |
| FallInjury, poisoning and procedural complications | 3/52 | 9/112 | 6/165 |
| DiarrhoeaGastrointestinal disorders | 2/52 | 8/112 | 13/165 |
Enrolled patients
| Age, Continuous(years) | Hydrocodone ER |
|---|---|
| Mean | 54.4 ± 11.51 |
| Sex: Female, Male(Participants) | Hydrocodone ER |
|---|---|
| Female | 197 |
| Male | 133 |
| Race/Ethnicity, Customized(Participants) | Hydrocodone ER |
|---|---|
| White | 260 |
| Black | 66 |
| Asian | 2 |
| Pacific Islander | 1 |
| Other | 1 |
| Race/Ethnicity, Customized(Participants) | Hydrocodone ER |
|---|---|
| Hispanic or Latino | 10 |
| Non-Hispanic and non-Latino | 319 |
| Unknown | 1 |
| Weight(kg) | Hydrocodone ER |
|---|---|
| Mean | 95.6 ± 23.97 |
| Height(cm) | Hydrocodone ER |
|---|---|
| Mean | 169.7 ± 10.57 |
| Body Mass Index(kg/m^2) | Hydrocodone ER |
|---|---|
| Mean | 33.1 ± 7.38 |
| Type of Pain(Participants) | Hydrocodone ER |
|---|---|
| Low back pain | 113 |
| Back pain | 103 |
| Osteoarthritis | 82 |
| Diabetic peripheral neuropathy | 12 |
| Postherpetic neuralgia | 0 |
| Traumatic injury | 3 |
| Neck pain | 10 |
| Complex regional pain syndrome | 3 |
| Rheumatoid arthritis | 2 |
| Other | 2 |
2 further baseline measures are reported on the registry.
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