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Trial record 1 of 1 for:    black widow spider III
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Black Widow Spider Antivenin for Patients With Systemic Latrodectism (BWSP3)

This study has been completed.
Sponsor:
Collaborator:
Rare Disease Therapeutics Inc.
Information provided by (Responsible Party):
Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00657540
First received: April 9, 2008
Last updated: August 16, 2017
Last verified: August 2017
  Purpose
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 hours of symptom onset. This study will be a phase III, multi-center, double-blind, randomized controlled study that takes place in emergency departments. The primary aim of this study is to determine the proportion of patients in which pain control was not achieved by 48 hours post treatment. Secondary aims are as follows: 1) a reduction in pain intensity at the end of the treatment phase compared to baseline; 2) the proportion of patients with a clinically significant decrease in pain intensity at 30 minutes post-treatment; 3) the proportion of patients in which drug-related adverse events occurred; and 4) to determine if serious, drug-related adverse events in Analatro-treated patients occurred at a rate greater than one in 10 (10%).

Condition Intervention Phase
Latrodectism Drug: Analatro Drug: Saline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter Clinical Trial of Analatro® [Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2] in Patients With Systemic Latrodectism

Resource links provided by NLM:


Further study details as provided by Instituto Bioclon S.A. de C.V.:

Primary Outcome Measures:
  • Proportion of Treatment Failures [ Time Frame: From start of Dose 1 infusion to 48 hours post treatment ]

    The primary efficacy endpoint for this study was the proportion of subjects in which pain control was not achieved 48 hours post-study drug infusion as identified by treatment failure. A treatment failure was defined as a subject who did not achieve pain control during the treatment phase, up to 48 hours after Dose 1 infusion start time. Subjects were deemed treatment failures if they met one or more of the following criteria:

    • Subject did not complete the treatment phase due to absence of clinically significant improvement in pain intensity relative to baseline at 60, 90, 120, or 150 minutes post start of Dose 1.
    • Subject required treatment with commercially available antivenin or prescription pain medication for signs and symptoms associated with latrodectism at any time during the treatment phase up to 48 hours after Dose 1 infusion start time.


Secondary Outcome Measures:
  • Reduction in Pain Intensity [ Time Frame: 30 minutes post treatment ]
    The proportion of patients with a clinically significant decrease in pain intensity at 30 minutes post-treatment (after Dose 1 and Dose 2, as applicable) will be measured by the patient's self-assessment of pain intensity using the visual analog scale (VAS). A clinically significant reduction in pain is defined as a decrease in VAS scores of greater than or equal to 13 mm.

  • Drug-related Adverse Events [ Time Frame: Start of Dose 1 through 17 days post treatment ]
    To evaluate safety of Analatro, the proportion of subjects experiencing at least one adverse event (AE) that was determined to be related to study drug was computed for each treatment group. All AEs classified as definitely or possibly related to study drug were considered drug-related.

  • Reduction in Pain Intensity [ Time Frame: Start of Dose 1 to any post-infusion time point ]
    The proportion of patients with a clinically significant decrease in pain intensity relative to baseline at any time point during the treatment phase was measured by the patient's self-assessment of pain intensity using the visual analog scale (VAS). A clinically significant reduction in pain was defined as a decrease in VAS scores of greater than or equal to 13 mm.

  • Drug-related Serious Adverse Events [ Time Frame: Start of Dose 1 through 17 days post treatment ]
    The proportion of subjects with drug-related serious adverse events.


Enrollment: 60
Study Start Date: August 2009
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2
Drug: Analatro
30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses
Placebo Comparator: 2
Normal Saline
Drug: Saline
50 mL of saline infused over 10 minutes
Other Name: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657540

Locations
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
United States, California
University of California Davis
Davis, California, United States, 95616
University California San Francisco - Fresno
Fresno, California, United States, 93701
University of California Irvine
Irvine, California, United States, 92697
Loma Linda University
Loma Linda, California, United States, 92354
University of California San Diego
San Diego, California, United States, 92103
San Diego Children's Hospital
San Diego, California, United States, 92123
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80010
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
United States, Florida
Cape Coral Hospital
Cape Coral, Florida, United States, 33990
University of Florida, Department of Emergency Medicine
Gainesville, Florida, United States, 32610
United States, Louisiana
LSU Health Sciences
Shreveport, Louisiana, United States, 71106
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Texas
Texas Tech - West Texas Regional Poison Center
El Paso, Texas, United States, 79905
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Instituto Bioclon S.A. de C.V.
Rare Disease Therapeutics Inc.
Investigators
Principal Investigator: Richard C Dart, MD, PhD Rocky Mountain Poison & Drug Center - Denver Health
Study Director: Walter Garcia, MD Instituto Bioclon S.A. de C.V.
  More Information

Responsible Party: Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier: NCT00657540     History of Changes
Other Study ID Numbers: XF-07/03
Study First Received: April 9, 2008
Results First Received: August 16, 2017
Last Updated: August 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Instituto Bioclon S.A. de C.V.:
black widow spider
antivenom
latrodectism

Additional relevant MeSH terms:
Antivenins
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 19, 2017