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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of GTX 2/3 in the treatment of acute back pain after 4 days of administration.