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The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain requiring around-the-clock opioid analgesia for an extended period of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone DETERx | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone DETERx | Drug | 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase | The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). | Randomized Baseline through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-exit From the Study for All Causes | Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module. | Randomization Baseline through Week 12 |
| Percent Reduction in Pain Intensity for Responders |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol specific inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Malamut, MD | Collegium Pharmaceutical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mesa | Arizona | 85282 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26262828 | Result | Katz N, Kopecky EA, O'Connor M, Brown RH, Fleming AB. A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain. Pain. 2015 Dec;156(12):2458-2467. doi: 10.1097/j.pain.0000000000000315. | |
| 28600725 | Derived |
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The titration (i.e., enrichment) phase of the study was designed to titrate patients to a dose of Oxycodone DETERx that balanced pain control and tolerability to ensure that only patients who experienced a substantial reduction from the screening pain assessment and who can tolerate side effects continue into the Double-blind Maintenance Phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxycodone DETERx (Titration Phase) | Achieve a stable Oxycodone DETERx dose of 40-160 mg total daily dose. |
| FG001 | Oxycodone DETERx (Double-blind Maintenance Phase) | Oxycodone DETERx: 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Phase |
|
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| Placebo | Drug | Placebo, divided into 2 doses, q12h |
|
Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity. |
| Screening Baseline through Week 12 |
| Weekly Changes in Pain Intensity | Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain). | Randomization Baseline and weekly through Week 12 |
| Rescue Medication Usage by Dose | Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study) | Randomization Baseline through Week 12 |
| Rescue Medication Use by Dosage | Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study) | Randomization Baseline through Week 12 |
| Patient Global Impression of Change (PGIC) | The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes "very much improved", "improved", "a little improved", "no change", "a little worse", "worse", and "very much worse". | Screening Baseline through Week 12 |
| Changes in Quality of Life | Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12. | Randomization Baseline through Week 12 |
| Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ) | The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain. | Randomization Baseline and Week 12 |
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Tucson | Arizona | 85704 | United States |
| Anaheim | California | 92801 | United States |
| Anaheim | California | 92804 | United States |
| Buena Park | California | 90620 | United States |
| Cerritos | California | 90703 | United States |
| Escondido | California | 92025 | United States |
| La Mesa | California | 91942 | United States |
| Napa | California | 94558 | United States |
| Pasadena | California | 91105 | United States |
| DeLand | Florida | 32720 | United States |
| Naples | Florida | 34108 | United States |
| Orlando | Florida | 32860 | United States |
| Plantation | Florida | 33317 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Columbus | Georgia | 31904 | United States |
| Marietta | Georgia | 30060 | United States |
| Indianapolis | Indiana | 46203 | United States |
| Valparaiso | Indiana | 46383 | United States |
| Overland Park | Kansas | 66211 | United States |
| Brockton | Massachusetts | 02301 | United States |
| Natick | Massachusetts | 01760 | United States |
| Watertown | Massachusetts | 02472 | United States |
| Pascagoula | Mississippi | 39581 | United States |
| St Louis | Missouri | 63128 | United States |
| Las Vegas | Nevada | 89123 | United States |
| Berlin | New Jersey | 08009 | United States |
| New York | New York | 10128 | United States |
| Rochester | New York | 14618 | United States |
| Williamsville | New York | 14221 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Oklahoma City | Oklahoma | 73116 | United States |
| Philadelphia | Pennsylvania | 19139 | United States |
| Charleston | South Carolina | 29406 | United States |
| Rapid City | South Dakota | 57702 | United States |
| New Tazewell | Tennessee | 37825 | United States |
| Austin | Texas | 78731 | United States |
| Dallas | Texas | 75230 | United States |
| Houston | Texas | 77098 | United States |
| Orem | Utah | 84058 | United States |
| Salt Lake City | Utah | 84106 | United States |
| Roanoke | Virginia | 24018 | United States |
| Bellevue | Washington | 98007 | United States |
| Kopecky EA, Vaughn B, Lagasse S, O'Connor M. Tolerability, Safety, and Effectiveness of Oxycodone DETERx in Elderly Patients >/=65 Years of Age with Chronic Low Back Pain: A Randomized Controlled Trial. Drugs Aging. 2017 Aug;34(8):603-613. doi: 10.1007/s40266-017-0473-7. |
| FG002 | Placebo (Double-blind Maintenance Phase) | Placebo: Placebo, divided into 2 doses, q12h |
| COMPLETED |
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| NOT COMPLETED |
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| Double-blind Maintenance Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxycodone DETERx (Double-blind Maintenance Phase) | |
| BG001 | Placebo (Double-blind Maintenance Phase) | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Pain Intensity-Numeric Rating Scale (PI-NRS) | The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase | The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). | One subject is missing all Average Weekly Pain Scores after Screening in the Oxycodone DETERx treatment group. This subject has been excluded from the analysis. | Posted | Mean | Standard Error | units on a scale | Randomized Baseline through Week 12 |
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| Secondary | Time-to-exit From the Study for All Causes | Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module. | Posted | Number | 95% Confidence Interval | Days | Randomization Baseline through Week 12 |
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| Secondary | Percent Reduction in Pain Intensity for Responders | Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity. | Posted | Number | participants | Screening Baseline through Week 12 |
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| Secondary | Weekly Changes in Pain Intensity | Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain). | Posted | Mean | Standard Deviation | units on a scale | Randomization Baseline and weekly through Week 12 |
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| Secondary | Rescue Medication Usage by Dose | Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study) | Posted | Mean | Standard Deviation | doses | Randomization Baseline through Week 12 |
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| Secondary | Rescue Medication Use by Dosage | Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study) | Posted | Mean | Standard Deviation | milligrams | Randomization Baseline through Week 12 |
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| Secondary | Patient Global Impression of Change (PGIC) | The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes "very much improved", "improved", "a little improved", "no change", "a little worse", "worse", and "very much worse". | Posted | Number | participants | Screening Baseline through Week 12 |
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| Secondary | Changes in Quality of Life | Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12. | Posted | Mean | Standard Error | units on a scale | Randomization Baseline through Week 12 |
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| Secondary | Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ) | The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain. | The RMDQ was analyzed and presented as a change from Randomization Baseline to Week 12. Subjects' scores from Early Discontinuation visits were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Randomization Baseline and Week 12 |
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Adverse events (AEs) were collected from the time of first dose with study drug to the End-of-Study Visit/Early Discontinuation Visit. All AEs that were ongoing at the subject's last study visit were to be followed until resolution or for 30 days after the subject's last study drug dose, whichever came first.
Serious adverse events (SAEs) were collected from informed consent until 30 days post last dose. If the Investigator became aware of an SAE within 30 days after the subject's last study drug dose, or through the last study visit, the SAE was to be reported. All SAEs, including those ongoing at End-of-Study/Early Discontinuation, were followed until resolution or until the outcome became chronically stable, or if no additional information could be obtained after unsuccessful contact attempts.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Screening | Serious Adverse Event (SAE) collection started during screening. | 2 | 1,297 | 0 | 0 | ||
| EG001 | Oxycodone DETERx (Titration Phase) | 8 | 740 | 531 | 740 | |||
| EG002 | Oxycodone DETERx (Double-blind Maintenance Phase) | 2 | 193 | 60 | 193 | |||
| EG003 | Placebo (Double-blind Maintenance Phase) | 2 | 196 | 39 | 196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Bradycardia | Cardiac disorders | MedDRA 15.1 |
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| Angina unstable | Cardiac disorders | MedDRA 15.1 |
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| Colitis ischaemic | Gastrointestinal disorders | MedDRA 15.1 |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 |
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| Sudden cardiac death | General disorders | MedDRA 15.1 | Not related to study drug as assessed by Principal Investigator and Medical Monitor |
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| Non-cardiac chest pain | General disorders | MedDRA 15.1 |
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| Pneumonia | Infections and infestations | MedDRA 15.1 |
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| Atypical pneumonia | Infections and infestations | MedDRA 15.1 |
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| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
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| Benign hydatidiform mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
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| Suicidal ideation | Psychiatric disorders | MedDRA 15.1 |
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| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-serious Adverse Events were not collected during screening. |
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| Headache | Nervous system disorders | MedDRA 15.1 | Non-serious Adverse Events were not collected during screening. |
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| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-serious Adverse Events were not collected during screening. |
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| Somnolence | Nervous system disorders | MedDRA 15.1 | Non-serious Adverse Events were not collected during screening. |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-serious Adverse Events were not collected during screening. |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-serious Adverse Events were not collected during screening. |
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| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-serious Adverse Events were not collected during screening. |
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If a joint manuscript has not been submitted for publication within twelve (12) months of completion or termination of the study, the PI is free to publish separately, upon provision of any proposed publication or manuscript to the Sponsor at least sixty (60) days before it is submitted or otherwise disclosed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientist | Collegium Pharmaceutical | +1.781.232.0764 | clinicaltrials@collegiumpharma.com |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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