A Phase 4 interventional study of Naproxen 500 Mg and Placebo in Sciatica, sponsored by Ostfold Hospital Trust. Completed at 4 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Ostfold Hospital Trust · Phase 4, Interventional, and Treatment
This study will evaluate whether treatment with Naproxen 500 mg twice daily is superior to placebo for the improvement of leg pain in patients with sciatica. Half of patients will receive Naproxen while the other half will receive placebo.
Sciatica is an established term for pain radiating from the lower back or buttock into the leg, commonly caused by a disc herniation. Given their analgesic and anti-inflammatory mechanisms of action, NSAIDs (Non-steroidal anti-inflammatory drugs) have been, and are still being regarded as standard therapy for sciatica.
However, very few randomised controlled trials of NSAIDs have been undertaken in sciatica, and no study has showed clinically meaningful effects as compared to placebo.
Since NSAIDs involve the risk of serious gastrointestinal, vascular and renal side effects there is a strong need to clarify their potential beneficial effects in sciatica.
149 studies on the registry are indexed under Sciatica; 31 are open to participants now.
This study's enrollment of 123 is above the median of 68 across 122 interventional studies indexed under Sciatica.
Browse Sciatica studies →Ostfold Hospital Trust is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Naproxen 500 mg twice daily
Drug: Naproxen 500 Mg
Placebo 1 tablet twice daily
Drug: Placebo
10 days treatment with Naproxen 500 mg twice daily
10 days treatment with Placebo1 tablet twice daily
Leg pain
A 0-10 numeric rating scale of average leg pain intensity in the previous 24 hours
Time frame: Daily from baseline to day10
Back pain
24 h average back pain will be assessed by a 0-10 numeric rating scale
Time frame: Daily from baseline to day10
Disability
Roland Morris Disability Questionnaire modified for use in sciatica
Time frame: Day 0, day 5, day, day 10, day 12
Sciatica symptoms
Sciatica Bothersomeness Index
Time frame: Day 0, day 5, day, day 10, day 12
Work
Ability to work and study as normal
Time frame: Day 0, day 10, day 12
Improvement
Global perceived change of sciatica/back problem on a verbal rating scale (Completely gone, much better, better, a little better, no change, a little worse, worse and much worse).
Time frame: Day 5, day 10
Rescue medication
Intake of Paracetamol 500 mg tablets (rescue medication) for pain
Time frame: Daily from day1 to day10
Opioid medication
Intake of opioid medication (weak or strong) for pain
Time frame: Daily from day1 to day10
Responder
\>30% and \>50% reduction in leg pain relative to baseline
Time frame: Day 5, day 10
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Naproxen
Ostfold Hospital Trust