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Trial record 15 of 112 for:    EPLERENONE

Eplerenone as a Supplement to Epidural Steroid Injections

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ClinicalTrials.gov Identifier: NCT03418649
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Harsh Sachdeva, University of Cincinnati

Brief Summary:
Low back pain is a leading cause of disability and health care costs in the United States, and treatments are ineffective for many patients. Epidural steroid injections are a common treatment, but their efficacy has been questioned and for many patients they do not provide complete relief. The investigators hypothesize, based on preclinical studies, that lack of complete efficacy may be due to the fact that clinically used steroids activate not only the intended drug target, the glucocorticoid receptor, but also the pro-inflammatory mineralocorticoid receptor. To test this hypothesis, this pilot study will recruit patients scheduled for lumbar epidural steroid injections for degenerative disc disease, and randomize them to receive a concurrent treatment with oral eplerenone (a clinically approved antagonist of the mineralocorticoid receptor) or placebo for 10 days starting just after the epidural injection. At several time points during the following year, subjects will answer the Oswestry Low Back Pain Questionnaire, to report on both pain and functional outcomes.

Condition or disease Intervention/treatment Phase
Degenerative Intervertebral Discs Sciatic Radiculopathy Low Back Pain Drug: Eplerenone 50 Mg Tab Drug: Placebo Oral Tablet Phase 4

Detailed Description:

Patients with degenerative disc disease, who are recommended to have an epidural steroid injection as part of their routine clinical care, will be invited to participate in the study prior to their first epidural steroid injection. If they consent, they will complete the Oswestry Low Back Pain Questionnaire (version 2) just prior to their first injection which captures the functional effects of back pain on various activities, providing a more meaningful picture than a simple static pain rating.

The subjects will complete the Oswestry Low Back Pain Questionnaire again four weeks after their first injection, a time point at which patients routinely have a follow-up visit. Patients referred for a second injection at this time will complete an additional Oswestry just prior to that injection. Subjects will be asked to complete additional Oswestry Low Back Pain Questionnaires at 3 months, 6 months, 1 year after their epidural injection (or after their second epidural injection if this is recommended).

Prior to receiving study medication (eplerenone or placebo), subjects will provide a blood sample to examine their creatinine and potassium levels, to ensure there are no contraindications to taking eplerenone.

In addition to the pain questionnaires, data will be collected from the subjects' medical charts regarding basic clinical demographics and clinical outcome of the epidural steroid injection.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind placebo controlled. Equal numbers of subjects receive 10 day course of eplerenone or placebo following their clinically indicated epidural steroid injection
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Drug or look-alike placebo dispensed according to a randomization schedule.
Primary Purpose: Treatment
Official Title: Epidural Steroid Injection With Supplemental Oral Eplerenone for Low Back Pain: A Prospective, Double Blind Randomized Trial
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: Experimental
Eplerenone 50 Mg Tab
Drug: Eplerenone 50 Mg Tab
50 mg PO per day for 10 days
Other Name: Inspra

Placebo Comparator: Control
Placebo Oral Tablet
Drug: Placebo Oral Tablet
PO once daily for 10 days
Other Name: placebo for eplerenone




Primary Outcome Measures :
  1. change in Oswestry Low Back Pain Disability Questionnaire at 12 months [ Time Frame: Difference between score prior to and 12 months after epidural steroid injection ]
    back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.


Secondary Outcome Measures :
  1. epidural steroid injection clinical outcome [ Time Frame: evaluated one month after injection as part of standard clinical care ]
    scored as 1 adequate pain relief, no further treatment recommended; 2, partial relief, second injection recommended; 3 little pain relief, alternative treatment recommended

  2. change in Oswestry Low Back Pain Disability Questionnaire at 4 weeks [ Time Frame: Difference between score prior to and 4 weeks after epidural steroid injection ]
    back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.

  3. change in Oswestry Low Back Pain Disability Questionnaire at 3 months [ Time Frame: Difference between score prior to and 3 months after epidural steroid injection ]
    back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.

  4. change in Oswestry Low Back Pain Disability Questionnaire at 6 months [ Time Frame: Difference between score prior to and 6 months after epidural steroid injection ]
    back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of lumbar degenerative disc disease demonstrated on either lumbar X-Ray or lumbar MRI.
  • unilateral radicular symptoms or electromyograph consistent with radiculopathy and exam findings corresponding to this diagnosis: with symptoms reflecting a dermatomal distribution of pain and positive response to straight leg raise test
  • Scheduled for lumbar epidural steroid injection as part of routine clinical care
  • Negative pregnancy test, if of childbearing potential

Exclusion Criteria:

  • Unable to complete questionnaires or give informed consent in English
  • Unavailable for follow-up contacts to complete questionnaires
  • Renal impairment (estimated glomerular filtration rate <50 mL/min or serum creatinine >1.8mg/dL) on metabolic panel obtained just prior to epidural injections.
  • Elevated serum potassium (>5.5 milliequivalents/L) on metabolic panel obtained just prior to epidural injections.
  • Have undergone previous lumbar surgery.
  • Treated with oral steroids or injectable steroid within the past year.
  • Diabetic
  • Systolic blood pressure reading less than 100 mm Hg at most recent clinic visit.
  • Prescribed protease inhibitors.
  • Taking strong CYP3A4 inhibitors
  • Taking potassium supplements or potassium-sparing diuretics (amiloride, spironolactone, or triamterene) or using salt substitutes that contain potassium (examples given below and in the prescreening document to be used by the study nurse).
  • Lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418649


Contacts
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Contact: Timothy J Burroughs, MD 513-375-8876 burrout@ucmail.uc.edu
Contact: Jun-Ming Zhang, MD MSc 513-558-2427 jun-ming.zhang@uc.edu

Locations
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United States, Ohio
UC Health Pain Medicine Center in Midtown Recruiting
Cincinnati, Ohio, United States, 45213
UC Health Pain Medicine Center in West Chester Not yet recruiting
West Chester, Ohio, United States, 45069
UC Health Pain Medicine Center West Chester Recruiting
West Chester, Ohio, United States, 45069
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Timothy J Burroughs, MD University of Cincinnati
  Study Documents (Full-Text)

Documents provided by Harsh Sachdeva, University of Cincinnati:
Study Protocol  [PDF] August 22, 2017
Statistical Analysis Plan  [PDF] January 17, 2018


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Responsible Party: Harsh Sachdeva, Assistant Professor of Anesthesiology & Pain Management, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03418649     History of Changes
Other Study ID Numbers: 2017-2713
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Harsh Sachdeva, University of Cincinnati:
low back pain
radicular pain
degenerative disc disease
Additional relevant MeSH terms:
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Eplerenone
Intervertebral Disc Degeneration
Radiculopathy
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents