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Trial record 67 of 667 for:    OXYCODONE

Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)

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ClinicalTrials.gov Identifier: NCT01685684
Recruitment Status : Completed
First Posted : September 14, 2012
Results First Posted : February 23, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Collegium Pharmaceutical, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Low Back Pain
Interventions Drug: Oxycodone DETERx
Drug: Placebo
Enrollment 740
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Oxycodone DETERx (Titration Phase) Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description Achieve a stable Oxycodone DETERx dose of 40-160 mg total daily dose. Oxycodone DETERx: 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h Placebo: Placebo, divided into 2 doses, q12h
Period Title: Titration Phase
Started 740 0 0
Completed 389 0 0
Not Completed 351 0 0
Period Title: Double-blind Maintenance Phase
Started 0 193 196
Completed 0 122 100
Not Completed 0 71 96
Arm/Group Title Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase) Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 193 196 389
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 193 participants 196 participants 389 participants
49.2  (13.31) 49.9  (12.56) 49.5  (12.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 196 participants 389 participants
Female
103
  53.4%
103
  52.6%
206
  53.0%
Male
90
  46.6%
93
  47.4%
183
  47.0%
Pain Intensity-Numeric Rating Scale (PI-NRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 193 participants 196 participants 389 participants
3.0  (1.04) 2.9  (0.97) 2.9  (1.00)
[1]
Measure Description: The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
1.Primary Outcome
Title 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
Hide Description The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame Randomized Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 192 196
Mean (Standard Error)
Unit of Measure: units on a scale
0.29  (0.146) 1.85  (0.223)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxycodone DETERx (Double-blind Maintenance Phase), Placebo (Double-blind Maintenance Phase)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Marginal Mean Difference (Net)
Estimated Value -1.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.267
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time-to-exit From the Study for All Causes
Hide Description 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.
Time Frame Randomization Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 193 196
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Days
58.0
(37.0 to 78.0)
35.0
(29.0 to 38.0)
3.Secondary Outcome
Title Percent Reduction in Pain Intensity for Responders
Hide Description 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.
Time Frame Screening Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 193 196
Measure Type: Number
Unit of Measure: participants
Subjects with 30% Improvement 95 65
Subjects with 50% Improvement 74 48
4.Secondary Outcome
Title Weekly Changes in Pain Intensity
Hide Description 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).
Time Frame Randomization Baseline and weekly through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 193 196
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 0.1  (0.85) 0.3  (1.17)
Week 2 0.0  (1.05) 0.4  (1.46)
Week 3 0.1  (1.14) 0.5  (1.78)
Week 4 0.1  (1.25) 0.8  (1.86)
Week 5 0.2  (1.41) 0.7  (1.86)
Week 6 0.2  (1.45) 0.7  (1.95)
Week 7 0.1  (1.35) 0.7  (2.00)
Week 8 0.0  (1.29) 0.8  (2.06)
Week 9 0.1  (1.59) 0.7  (2.15)
Week 10 0.2  (1.55) 0.7  (2.20)
Week 11 0.2  (1.62) 0.8  (2.23)
Week 12 0.3  (1.54) 0.8  (2.29)
5.Secondary Outcome
Title Rescue Medication Usage by Dose
Hide Description 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)
Time Frame Randomization Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 193 196
Mean (Standard Deviation)
Unit of Measure: doses
Doses per Day 0.15  (0.297) 0.23  (0.458)
Doses per Week 1.04  (2.081) 1.60  (3.206)
Total Number of Doses 8.0  (16.38) 11.2  (31.55)
6.Secondary Outcome
Title Rescue Medication Use by Dosage
Hide Description Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)
Time Frame Randomization Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 193 196
Mean (Standard Deviation)
Unit of Measure: milligrams
Dosage per Day 144.63  (289.472) 189.32  (317.605)
Dosage per Week 1012.39  (2026.298) 1325.27  (2223.231)
Total Dosage 7873.1  (16665.70) 9028.1  (20441.67)
7.Secondary Outcome
Title Patient Global Impression of Change (PGIC)
Hide Description 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".
Time Frame Screening Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 122 100
Measure Type: Number
Unit of Measure: participants
Very Much Improved 36 17
Improved 52 39
A Little Improved 23 26
No Change 9 12
A Little Worse 0 4
Worse 2 1
Very Much Worse 0 1
8.Secondary Outcome
Title Changes in Quality of Life
Hide Description 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.
Time Frame Randomization Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 193 196
Mean (Standard Error)
Unit of Measure: units on a scale
Physical Component Score 7.524  (10.1327) 3.622  (9.4290)
Mental Component Score -2.554  (10.4145) 0.674  (11.1676)
Physical Functioning 0.6  (1.35) 0.5  (1.00)
Role Physical 1.2  (2.35) 0.6  (2.16)
Bodily Pain 0.7  (1.16) 0.4  (1.29)
General Health 0.28  (0.784) 0.22  (0.789)
9.Secondary Outcome
Title Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)
Hide Description 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.
Time Frame Randomization Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 109 90
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.4  (4.83) 0.7  (5.32)
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Screening Oxycodone DETERx (Titration Phase) Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Hide Arm/Group Description Serious Adverse Event (SAE) collection started during screening. [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Screening Oxycodone DETERx (Titration Phase) Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Screening Oxycodone DETERx (Titration Phase) Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/1297 (0.15%)   8/740 (1.08%)   2/193 (1.04%)   2/196 (1.02%) 
Cardiac disorders         
Sinus Bradycardia  1/1297 (0.08%)  0/740 (0.00%)  0/193 (0.00%)  0/196 (0.00%) 
Angina unstable  0/1297 (0.00%)  1/740 (0.14%)  0/193 (0.00%)  0/196 (0.00%) 
Gastrointestinal disorders         
Colitis ischaemic  0/1297 (0.00%)  1/740 (0.14%)  0/193 (0.00%)  0/196 (0.00%) 
Gastrooesophageal reflux disease  0/1297 (0.00%)  1/740 (0.14%)  0/193 (0.00%)  0/196 (0.00%) 
General disorders         
Sudden cardiac death 1 [1]  0/1297 (0.00%)  1/740 (0.14%)  0/193 (0.00%)  0/196 (0.00%) 
Non-cardiac chest pain  0/1297 (0.00%)  0/740 (0.00%)  0/193 (0.00%)  1/196 (0.51%) 
Infections and infestations         
Pneumonia  0/1297 (0.00%)  1/740 (0.14%)  0/193 (0.00%)  0/196 (0.00%) 
Atypical pneumonia  0/1297 (0.00%)  0/740 (0.00%)  1/193 (0.52%)  0/196 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Pituitary tumour benign  0/1297 (0.00%)  1/740 (0.14%)  0/193 (0.00%)  0/196 (0.00%) 
Benign hydatidiform mole  0/1297 (0.00%)  0/740 (0.00%)  0/193 (0.00%)  1/196 (0.51%) 
Psychiatric disorders         
Suicidal ideation  0/1297 (0.00%)  1/740 (0.14%)  0/193 (0.00%)  0/196 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Emphysema  1/1297 (0.08%)  0/740 (0.00%)  0/193 (0.00%)  0/196 (0.00%) 
Asthma  0/1297 (0.00%)  1/740 (0.14%)  1/193 (0.52%)  0/196 (0.00%) 
1
Term from vocabulary, MedDRA 15.1
[1]
Not related to study drug as assessed by Principal Investigator and Medical Monitor
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Screening Oxycodone DETERx (Titration Phase) Oxycodone DETERx (Double-blind Maintenance Phase) Placebo (Double-blind Maintenance Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   531/740 (71.76%)   60/193 (31.09%)   39/196 (19.90%) 
Gastrointestinal disorders         
Nausea 1 [1]  0/0  123/740 (16.62%)  21/193 (10.88%)  9/196 (4.59%) 
Constipation 1 [1]  0/0  96/740 (12.97%)  10/193 (5.18%)  1/196 (0.51%) 
Vomiting 1 [1]  0/0  47/740 (6.35%)  8/193 (4.15%)  3/196 (1.53%) 
Nervous system disorders         
Headache 1 [1]  0/0  103/740 (13.92%)  12/193 (6.22%)  23/196 (11.73%) 
Somnolence 1 [1]  0/0  65/740 (8.78%)  1/193 (0.52%)  0/196 (0.00%) 
Dizziness 1 [1]  0/0  42/740 (5.68%)  3/193 (1.55%)  0/196 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus 1 [1]  0/0  55/740 (7.43%)  5/193 (2.59%)  3/196 (1.53%) 
1
Term from vocabulary, MedDRA 15.1
[1]
Non-serious Adverse Events were not collected during screening.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Scientist
Organization: Collegium Pharmaceutical
Phone: +1.781.232.0764
EMail: clinicaltrials@collegiumpharma.com
Layout table for additonal information
Responsible Party: Collegium Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT01685684     History of Changes
Other Study ID Numbers: CP-OXYDET-08
First Submitted: September 12, 2012
First Posted: September 14, 2012
Results First Submitted: May 25, 2016
Results First Posted: February 23, 2017
Last Update Posted: February 26, 2019