Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain
NCT ID: NCT02741076
Last Updated: 2019-11-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
44 participants
INTERVENTIONAL
2016-09-14
2018-04-27
Brief Summary
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Detailed Description
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The original protocol (10 Jan 2016) was amended twice: Amendment 1 (07 Jul 2016) and Amendment 2 (08 Feb 2017). Screening of subjects only started after Amendment 1 approval. Approximately half the subjects were screened under Amendment 1 and half under Amendment 2. The original statistical analysis plan (SAP) was amended twice as well based on the protocol amendments. The current SAP is version 1.3, dated 11 April 2018, which added a section to list the analyses that were not being completed as a result of the premature termination of this study.
The duration of the entire study for each subject was approximately 33 to 37 weeks. For Suboptimal Responders: the study duration included Screening Period of up to 3 weeks, Run-in Period of 1 week, Baseline Period of 1 week, Blinded Structured Opioid Discontinuation Period of 24 weeks, and Follow-up Period of 4 weeks.
For Optimal Responders: the study duration included Screening Period of up to 3 weeks, Observation Period of 1 week, Taper Period up to 2 weeks, Open Label Titration Period of 3 weeks, Blinded Structured Opioid Discontinuation Period of 24 weeks, and Follow-up Period of 4 weeks.
The primary endpoint was the change in the mean Average PI score on the 0-10 Numerical Ratings Scale (NRS) from Baseline to the 1 week period before the Week 12 visit. Data were summarized using descriptive statistics (number of observations \[n\], mean, standard deviation, median, first and third quartiles, minimum, and maximum for continuous variables; and frequency and percentage for categorical variables). Due to the inability to recruit a sufficient number of subjects over an acceptable period of time, the study was terminated prematurely and efficacy analyses were reduced and only a brief summary of the statistical analyses of the primary endpoint in each group (Suboptimal Responders and Optimal Responders) were performed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Structured discontinuation opioid therapy Suboptimal Responder
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Structured discontinuation opioid therapy Optimal responders
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy Suboptimal responders
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Structured Continuation of opioid therapy Optimal responders
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Interventions
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Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Eligibility Criteria
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Inclusion Criteria
2. Have a clinical diagnosis of non-radicular CLBP (pain that occurs in an area with boundaries between the lowest rib and the crease of the buttocks) of Class 1 or proximal radicular (above the knee) pain of Class 2 based on the Quebec Task Force Classification for Spinal Disorders (subjects with previous surgery or chronic pain syndrome, i.e., classes 9.2 or 10, will be allowed if their pain does not radiate or radiates only proximally) for a minimum of 12 months and
1. For the Suboptimal Responder group, pain must have been present for at least several hours a day and have an Average PI score of 6-9 on an 11-point NRS within the past 24 hours of screening.
2. For the Optimal Responder group, subjects must have an Average PI score of 1-4 on an 11-point NRS within the past 24 hours of screening.
3. Have been taking ER/LA opioids or immediate release opioids (at least 4 times at day) for at least 12 months.
4. Have been taking one of the 3 index ER opioid drugs around-the-clock at a twice-a-day frequency for at least 3 consecutive months at a total daily dose within the range shown below.
Daily Dose Range
1. Morphine sulfate extended-release: 120-540mg
2. Oxycodone extended-release: 80-360mg
3. Oxymorphone extended-release: 40-180mg
5. Be considered, in the opinion of the Investigator, to be in generally good health other than CLBP at screening based upon the results of a medical history, physical examination, 12-lead ECG, and laboratory profile.
6. Speak, read, write, and understand English (to reduce heterogeneity of data), understand the consent form, and be able to effectively communicate with the study staff.
7. Have access to the Internet (to access the patient support program).
8. Voluntarily provide written informed consent.
9. Be willing and able to complete study procedures.
Exclusion Criteria
2. Have a primary diagnosis of fibromyalgia, complex regional pain syndrome, neurogenic claudication due to spinal stenosis, spinal cord compression, acute nerve root compression, severe or progressive lower extremity weakness or numbness, bowel or bladder dysfunction as a result of cauda equina compression, diabetic amyotrophy, meningitis, diskitis, back pain because of secondary infection or tumor, or pain caused by a confirmed or suspected neoplasm.
3. Have undergone a surgical procedure for back pain within 6 months prior to the Screening Visit.
4. Have had a nerve or plexus block, including epidural steroid injections or facet blocks, within 1 month prior to the Screening Visit or botulinum toxin injection in the lower back region within 3 months prior to screening.
5. Have a history of confirmed malignancy within past 2 years, with exception of basal cell or squamous cell carcinoma of the skin that has been successfully treated.
6. Have uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure \>180 mm Hg or \<90 mm Hg, or a sitting diastolic blood pressure \>110 mmHg or \<40 mm Hg at screening.
7. Have a body mass index (BMI) \>45 kg/m2. Anyone with a BMI \>40 but \<45 will complete a screening tool (STOPBang Questionnaire) to rule out high risk of obstructive sleep apnea.
8. Have clinically significant depression based on a score of ≥20 on the Patient Health Questionnaire (PHQ-8)
9. Have suicidal ideation associated with actual intent and a method or plan in the past year: "Yes" answers on items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS).
10. Have a previous history of suicidal behaviors in the past 5 years: "Yes" answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS.
11. Have any lifetime history of serious or recurrent suicidal behavior. (Non-suicidal self-injurious behavior is not a trigger for a risk assessment unless in the Investigator's judgment it is indicated.)
12. Have clinically significant abnormality in clinical chemistry, hematology or urinalysis, including serum glutamic-oxaloacetic transaminase/aspartate aminotransferase or serum glutamic pyruvic transaminase/alanine aminotransferase ≥3 times the upper limit of the reference range or a serum creatinine \>2 mg/dL at screening.
13. Have severe enough psychiatric or substance abuse disorder to compromise the subject's safety or scientific integrity of the study.
14. Have on-going litigation associated with back pain or pending applications for workers compensation or disability issues or subjects who plan on filing litigation or claims within the next 12 months; subjects with settled past litigations will be allowed as will subjects who have been on workers compensation or disability claims for at least 3 months.
15. Have used a monoamine oxidase inhibitor within 14 days prior to the start of study medication.
16. Are taking agonist-antagonists (pentazocine, butorphanol or nalbuphine), buprenorphine, methadone, barbiturates, or more than one type of benzodiazepine within 1 month prior to screening.
17. Have a positive urine drug test (UDT) for illicit drugs (including marijuana), non-prescribed controlled substances (opioid or non-opioid), or alcohol at screening.
18. Have taken any investigational drug within 30 days prior to the Screening Visit or are currently enrolled in another investigational drug study.
18 Years
75 Years
ALL
No
Sponsors
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Member Companies of the Opioid PMR Consortium
INDUSTRY
Responsible Party
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Locations
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G & L Research
Foley, Alabama, United States
Horizon Research Partners
Mobile, Alabama, United States
Healthscan Clinical Trials
Montgomery, Alabama, United States
Center for Pain and Supportive Care
Phoenix, Arizona, United States
The Pain Center of Arizona
Phoenix, Arizona, United States
Quality of Life Medical and Research Centers
Tucson, Arizona, United States
Coastal Pain and Spinal Diagnostics
Carlsbad, California, United States
Aviva Research
Escondido, California, United States
Global Clinical Trials
Irvine, California, United States
The Helm Center for Pain Management
Laguna Woods, California, United States
Alexander Ford, MD
Los Angeles, California, United States
Samaritan Center for Medical Research
Los Gatos, California, United States
Catalina Research Institute
Montclair, California, United States
North Country Clinical Research
Oceanside, California, United States
Westview Clinical Research
Placentia, California, United States
Foothills Pain Management Clinic
Pomona, California, United States
Northern California Research
Sacramento, California, United States
Breakthrough Clinical Trials
San Bernardino, California, United States
Optimus Medical Group
San Francisco, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Care Research Center
Doral, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Eastern Research
Hialeah, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Future Clinical Research
Miami, Florida, United States
South Florida Clinical Research
Miami, Florida, United States
Empire Clinical Research
Miami Lakes, Florida, United States
Martin E Hale, MD
Plantation, Florida, United States
Florida Medical Pain Management
St. Petersburg, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Georgia Institute for Clinical Research
Marietta, Georgia, United States
Sestron Clinical Research
Marietta, Georgia, United States
Healthcare Research Network II
Blue Island, Illinois, United States
Indiana Pain and Spine Clinic
South Bend, Indiana, United States
Mid-American Psysiatrists
Overland Park, Kansas, United States
WK River Cities Clinical Research Center
Shreveport, Louisiana, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
Oakland Medical Research
Troy, Michigan, United States
Healthcare Research Network
Hazelwood, Missouri, United States
St Louis Clinical Trials
St Louis, Missouri, United States
Red Rock Clinical Research
Las Vegas, Nevada, United States
OnSite Clinical Solutions
Mooresville, North Carolina, United States
Clinical Trials of America
Winston-Salem, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Prestige Clinical Research
Franklin, Ohio, United States
North Star Medical Research
Middleburg Heights, Ohio, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Medical Research International
Oklahoma City, Oklahoma, United States
SP Research
Oklahoma City, Oklahoma, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, United States
Founders Research Corporation
Philadelphia, Pennsylvania, United States
Carolina Center for Advanced Management of Pain
Spartanburg, South Carolina, United States
Healthy Concepts
Rapid City, South Dakota, United States
Comprehensive Pain Specialists
Hendersonville, Tennessee, United States
New Phase Research and Development
Knoxville, Tennessee, United States
Biopharma Informatic Research Center
Houston, Texas, United States
Coastal Medical Group
Houston, Texas, United States
Highland Clinical Research
Salt Lake City, Utah, United States
Interventional Pain and Spine Specialists
Chester, Virginia, United States
Healing Hands of Virginia
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2065-5
Identifier Type: -
Identifier Source: org_study_id
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