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

NCT01455519 | Completed Phase 4 Results DMC

• 1 other identifier: RIC_Cov_2011
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Back Pain; Chronic back pain

Outcome Measures

Primary Outcomes (2)

• Change in McGill Pain Questionnaire - Short Form

  The McGill Pain Questionnaire - Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).

  Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

• Change in VAS

  Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).

  Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Secondary Outcomes (11)

• Change in PASS

  Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

• Change in Pain Disability

  Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

• Change in Stair Climb Time

  Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

• Change in Treadmill Distance Walked

  Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

• Change in Sit to Stand Repetitions

  Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Subjects may receive a pill with no medicine.

Drug: Sugar pill

Hydromorphone ER

ACTIVE COMPARATOR

Subjects received study drug: Hydromorphone ER

Drug: Hydromorphone ER

Interventions

Hydromorphone ER DRUG

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.

Also known as: Exalgo(hydromorphone HCl), CII (77605306)

Hydromorphone ER

Sugar pill DRUG

Sugar pill

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets our criteria for Chronic Non-Radicular Back Pain (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 Numeric Rating scale (NRS) at phone screening, or pain greater than or equal to 50 on VAS at visit one.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Mallinckrodt: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Links

• Site Contact Information

MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Sugars

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Center for Pain Studies
• Organization: Rehabilitation Institute of Chicago

centerforpainstudies@ric.org

312.238.5654

Study Officials

• Norman Harden, M.D.

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 20, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 24, 2017
• Results First Posted: July 13, 2015

Record last verified: 2017-10

Locations

US (1)