True Functional Restoration and Analgesia in Non-Radicular Low Back Pain (Covidien)

This study has been completed.
Information provided by (Responsible Party):
Dr. Norman Harden, Rehabilitation Institute of Chicago Identifier:
First received: October 11, 2011
Last updated: January 8, 2015
Last verified: January 2015

You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.

Condition Intervention Phase
Low Back Pain
Drug: Hydromorphone ER
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: True Functional Restoration and Analgesia in Non-Radicular Low Back Pain: a Prospective Double Blind, Placebo-controlled Study of Hydromorphone ER

Resource links provided by NLM:

Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • The efficacy of Exalgo (hydromorphone HCl extended release) in Chronic Non-Radicular Low Back Pain (CNRBP) model syndrome to improve pain, function and activity [ Time Frame: Three visits over eight week period ] [ Designated as safety issue: No ]
    Intent to treat analyses will compare data from the groups for all participants with at least two data points. A series of mixed design ANOVAs will be completed with data from objective functional testing, quasi-objective functional and psychophysical testing, subject pain questionnaires and subjective perceived function and quality of life.

Secondary Outcome Measures:
  • The relationship between pain ratings and functioning [ Time Frame: Three visits over an eight week period ] [ Designated as safety issue: No ]
    A second set of follow-up analyses will test for nonlinear patterns of change over time. It is expected that some outcome factors will show quadratic trends such that, for instance, activity level will change depending on pain ratings.

Enrollment: 26
Study Start Date: October 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill
Subjects may receive a pill with no medicine.
Drug: 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.
Other Name: Exalgo(hydromorphone HCl), CII (77605306)
No Intervention: Hydromorphone ER
Hydromorphone ER

Detailed Description:

As a participant in this study, you will be asked to come to the Rehabilitation Institute of Chicago (RIC), Center for Pain Studies (446 E Ontario St. Suite 1011, Chicago, IL 60611). Your part in this study will last for 8 weeks and will involve 3 visits to the Rehabilitation Institute of Chicago and anywhere from weekly phone calls to phone calls every other day.

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets our criteria for CNRBP: non-radiating (below buttocks), no frank weakness or atrophy, no sensory or reflex changes
  • 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 NRS scale at phone screening, or pain greater than or equal to 50 on VAS at visit one.

Exclusion Criteria:

  • Subjects with hypersensitivity to Opioids, Acetominophen or Exalgo.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01455519

United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Principal Investigator: Norman Harden, M.D. Rehabilitation Institute of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Norman Harden, Director, Center for Pain Studies, Rehabilitation Institute of Chicago Identifier: NCT01455519     History of Changes
Other Study ID Numbers: RIC_Cov_2011
Study First Received: October 11, 2011
Last Updated: January 8, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
Low Back Pain
Back Pain
Chronic back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on July 01, 2015