Status:
COMPLETED
Black Widow Spider Antivenin for Patients With Systemic Latrodectism
Lead Sponsor:
Instituto Bioclon S.A. de C.V.
Collaborating Sponsors:
Rare Disease Therapeutics Inc.
Conditions:
Latrodectism
Eligibility:
All Genders
10+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the efficacy and safety of a new antivenom called Analatro® for treating black widow spider bites in patients who present to a hospital emergency room within 24 ho...
Detailed Description
Instituto Bioclon S.A. de C.V. has developed Analatro®, an antibody fragment (Fab2) containing widow spider (Latrodectus) antivenom, and proposes to conduct a clinical trial in hospital emergency depa...
Eligibility Criteria
Inclusion
- Moderate to severe pain intensity measured using the visual analog scale (VAS score ≥ 40mm) at the start of screening phase (VAS 0)
- Diagnosis of latrodectism by the Investigator, with concurrence of diagnosis by a physician not directly involved with the study
- Moderate to severe pain intensity measured using the visual analog scale (VAS score ≥ 40mm) at Baseline (VAS 1)
Exclusion
- Less than 10 years of age
- Presents to the emergency department of any healthcare facility greater than 24 hours after onset of symptoms
- Has a known (self-reported) hypersensitivity to fentanyl, morphine, diazepam, or equine serum
- History of significant cardiac, respiratory, hepatic or renal disease, psychiatric disorder or chronic pain syndrome that in the investigator's assessment would confound efficacy or safety endpoint assessment (e.g., a bite to the leg of a patient with reflex sympathetic dystrophy)
- History or suspected history or substance abuse
- Pregnant or breast-feeding
- Has a distracting injury with acute pain, or is unable to make a reliable self-report of pain intensity to pain relief based solely on the condition of interest
- Was already treated with Merck Antivenin Latrodectus Mactans for signs/symptoms related to the current widow spider bite
- Unable to provide a telephone number to be contacted for follow-up interviews on Days 2, 10, and 17 after discharge from the emergency department
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00657540
Start Date
October 1 2009
End Date
October 1 2014
Last Update
April 3 2018
Active Locations (16)
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1
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
2
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
3
University of California Davis
Davis, California, United States, 95616
4
University California San Francisco - Fresno
Fresno, California, United States, 93701