True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
NCT ID: NCT01455519
Last Updated: 2017-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
51 participants
INTERVENTIONAL
2011-10-31
2014-12-31
Brief Summary
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Detailed Description
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If you are in this study, you will be placed in one of two study groups: one group will receive the study drug and one will receive a placebo. You will be assigned a study group by chance using a process similar to the flip of a coin. This process is called randomization. Neither you nor the study staff will select the group you will be in. A placebo looks like the study drug but is an inactive substance that has no medication. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. You will have a 66% chance of getting the study drug. You will receive placebo at some point during the study but you will not know whether you are receiving placebo or study drug during the entire study. However, if you have a medical emergency, the investigators can get this information.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sugar pill
Subjects may receive a pill with no medicine.
Sugar pill
Sugar pill
Hydromorphone ER
Subjects received study drug: Hydromorphone ER
Hydromorphone ER
Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
Interventions
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Hydromorphone ER
Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
Sugar pill
Sugar pill
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If female, is not pregnant or breast feeding, and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl).
* Able to read and speak English and provide informed consent; ages: 18-90.
* Able to understand and comply with all data collection methodology.
* Subjects may continue any non opioid, non acetaminophen stable drug regimen with no changes during the course of study and not use rescue medications 12 hours before testing.
* Subjects taking opioids must agree to detoxify for the protocol. If they agree they will detox under the direction of the PI before entering the protocol. They may begin the acetaminophen rescue med as per the protocol while in detox.
* Must have pain greater than or equal to 5 on a 10 point Numeric Rating scale (NRS) at phone screening, or pain greater than or equal to 50 on VAS at visit one.
Exclusion Criteria
* Subjects with severe or untreated psychiatric disturbance (e.g. mania, depression \[esp suicidality\], anxiety, substance dependence).
* Subjects with a clinical diagnosis of fibromyalgia or polymyalgia rheumatica.
* Subjects with severe ongoing or unaddressed medical conditions (e.g. Renal or Hepatic disease \[creatinine\>1.5 ml/dl; AST or ALT\> 3x normal limit\], uncontrolled hypertension), pulmonary disease, uncontrolled seizure disorder, gastoparesis or urinary retention.
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Principal Investigators
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Norman Harden, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Countries
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Related Links
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Site Contact Information
Other Identifiers
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RIC_Cov_2011
Identifier Type: -
Identifier Source: org_study_id