Gonyautoxin 2/3 in the Treatment of Acute Back Pain: A Clinical Proof-of-concept Study (NCT04799041) | Clinical Trial Compass
CompletedPhase 1/2
Gonyautoxin 2/3 in the Treatment of Acute Back Pain: A Clinical Proof-of-concept Study
Chile30 participantsStarted 2019-10-11
Plain-language summary
This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial.
The purpose of the study was to explore the clinical efficacy and safety of a single local IM injection of gonyautoxin 2/3 (GTX 2/3) compared to placebo in decreasing pain and improving lumbar functionality at short term follow-up in adult patients with acute low back pain, without radiculopathy.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Man or woman patients between 18 and 75 years old.
* Acute back pain episode without radiculopathy asociated and no red flags.
* Back pain related pain bigger than 4 in VAS.
* Patients with no severe illnesses or conditions that would be inappropriate to enroll in this study or patients with no chronic pain.
* Signed informed consent.
Exclusion Criteria:
* Pregnant women or breastfeeding.
* Hyper acute back pain that requires emergency hospitalization.
* Chronic back pain or complicated (red flags).
* Patients that have received previous analgesic therapy of long half life, like corticoids, for current back pain or other pathology (inhalers are excluded).
* Associated neuromuscular diseases, inflammatory diseases in the spine (Musculoskeletal Disorders 2017, 18; 454: 2-12), inability to stand up, tumoral diseases, terminal disease.
* Ongoing local treatment with calcium antagonists or trinitroglycerin.
* Treatment with anti-vitamins K or another anticoagulant.
* Patients with adverse psychosomatic, work or social factors.
* Known or suspected allergy to any component of the study drug.
* Current participation in another clinical study or 30 days prior to enrollment.
* Another condition that in the opinion of the PI prevents participation in the study (physical or mental) or that cannot attend controls or answer the patient's survey / diary.
What they're measuring
1
Efficacy of GTX 2/3 in the treatment of acute back pain after 4 days of administration.