Eplerenone as a Supplement to Epidural Steroid Injections

NCT03418649 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2017-2713
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Degenerative Intervertebral Discs; Sciatic Radiculopathy; Low Back Pain

Keywords

low back pain; radicular pain; degenerative disc disease

Outcome Measures

Primary Outcomes (1)

• change in Oswestry Low Back Pain Disability Questionnaire at 12 months

  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.

  Difference between score prior to and 12 months after epidural steroid injection

Secondary Outcomes (4)

• epidural steroid injection clinical outcome

  evaluated one month after injection as part of standard clinical care

• change in Oswestry Low Back Pain Disability Questionnaire at 4 weeks

  Difference between score prior to and 4 weeks after epidural steroid injection

• change in Oswestry Low Back Pain Disability Questionnaire at 3 months

  Difference between score prior to and 3 months after epidural steroid injection

• change in Oswestry Low Back Pain Disability Questionnaire at 6 months

  Difference between score prior to and 6 months after epidural steroid injection

Study Arms (2)

Experimental

EXPERIMENTAL

Eplerenone 50 Mg Tab

Drug: Eplerenone 50 Mg Tab

Control

PLACEBO COMPARATOR

Placebo Oral Tablet

Drug: Placebo Oral Tablet

Interventions

Eplerenone 50 Mg Tab DRUG

50 mg PO per day for 10 days

Also known as: Inspra

Experimental

Placebo Oral Tablet DRUG

PO once daily for 10 days

Also known as: placebo for eplerenone

Control

Eligibility Criteria

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

You may qualify if:

• diagnosis of lumbar degenerative disc disease demonstrated on either lumbar X-Ray or lumbar MRI.
• radicular symptoms or electromyograph consistent with radiculopathy and exam findings corresponding to this diagnosis
• Scheduled for lumbar epidural steroid injection at participating clinics as part of routine clinical care
• Negative pregnancy test, if of childbearing potential

You may not qualify if:

• 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 within the past year.
• Treated with lumbar epidural steroid injection within the past 3 months at the time of consent.
• Diabetic
• Systolic blood pressure reading less than 100 mm Hg at most recent pain 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (2)

UC Health Pain Medicine Center in Clifton

Cincinnati, Ohio, 45267, United States

Location

UC Health Pain Medicine Center in West Chester

West Chester, Ohio, 45069, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Shuchita Garg, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Drug or look-alike placebo dispensed according to a randomization schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology & Pain Management

Model Details: Double blind placebo controlled. Equal numbers of subjects receive 10 day course of eplerenone or placebo following their clinically indicated epidural steroid injection

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: February 1, 2018
• Study Start: June 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)