Status:
COMPLETED
Gonyautoxin 2/3 in the Treatment of Acute Back Pain: A Clinical Proof-of-concept Study
Lead Sponsor:
Algenis SpA
Conditions:
Back Pain
Acute Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 clini...
Detailed Description
This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial. The primary objective was to determine the clinic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04799041
Start Date
October 11 2019
End Date
March 19 2020
Last Update
March 16 2021
Active Locations (1)
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1
Hospital San José SSMN
Santiago, Santiago Metropolitan, Chile