Trial Outcomes & Findings for Dexamethasone Versus Depo Medrol in Lumbar Epidurals (NCT NCT01397552)

NCT ID: NCT01397552

Last Updated: 2023-11-22

Results Overview

Subjects will be asked to return at 2 wks, 6 wks and 12 weeks the above time points to complete outcome measurements questionnaires and undergo a neurological examination, the 12 weeks outcome should show improvement s/p injection

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 12 wk post injection
• Results posted on: 2023-11-22

Participant Flow

Participant milestones

Measure	Dexamethasone Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded Dexamethasone: 10 mg/mL injected into lumbar spine, one level, one injection	Methylprednisolone Acetate Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded methylprednisolone acetate: 80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time
Overall Study STARTED	4	4
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Dexamethasone Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded Dexamethasone: 10 mg/mL injected into lumbar spine, one level, one injection	Methylprednisolone Acetate Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded methylprednisolone acetate: 80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Dexamethasone Versus Depo Medrol in Lumbar Epidurals

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 12 wk post injection

Population: enrollment was too low and half of the subjects did not complete study requirements, no data collected for analysis

Subjects will be asked to return at 2 wks, 6 wks and 12 weeks the above time points to complete outcome measurements questionnaires and undergo a neurological examination, the 12 weeks outcome should show improvement s/p injection

Outcome measures

Outcome data not reported

Adverse Events

Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Methylprednisolone Acetate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Lavelle

Upstate Medical University

Phone: 315-464-4472

Email: lavellew@upstate.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place