Trial record 1 of 1 for:
Open Studies | "Black Widow Spider"
Black Widow Spider Antivenin for Patients With Systemic Latrodectism (BWS P3)
This study is currently recruiting participants.
Verified May 2012 by Instituto Bioclon S.A. de C.V.
Sponsor:
Instituto Bioclon S.A. de C.V.
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: May 14, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to test the effectiveness 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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Further study details as provided by Instituto Bioclon S.A. de C.V.:
Primary Outcome Measures:
- Pain Control [ Time Frame: 48 hours post treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Serious, drug-related adverse events [ Time Frame: 17 days post treatment ] [ Designated as safety issue: Yes ]
- Reduction in pain intensity [ Time Frame: End of treatment phase ] [ Designated as safety issue: No ]
- Reduction in pain intensity [ Time Frame: 30 minutes post treatment ] [ Designated as safety issue: No ]
- Drug-related adverse events [ Time Frame: 17 days post treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 56 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (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
Other Name: Analatro
|
|
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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657540
Contacts
| Contact: Beth Spradley, MNM, CCRP, CCRA | 303-389-1397 | Beth.Spradley@rmpdc.org |
Locations
| United States, Arizona | |
| Maricopa Medical Center | Recruiting |
| Phoenix, Arizona, United States, 85008 | |
| Contact: Mary Mulrow, RN, MN 602-344-5058 Mary_Mulrow@dmgaz.org | |
| Principal Investigator: Dan Quan, MD | |
| United States, California | |
| University of California Davis | Recruiting |
| Davis, California, United States, 95616 | |
| Contact: Shari Nichols shari.nichols@ucdmc.ucdavis.edu | |
| Principal Investigator: Mark Sutter, MD | |
| University California San Francisco - Fresno | Recruiting |
| Fresno, California, United States, 93701 | |
| Contact: Brandy Snowden BSnowden@fresno.ucsf.edu | |
| Principal Investigator: Danielle Campagne, MD | |
| University of California Irvine | Recruiting |
| Irvine, California, United States, 92697 | |
| Contact: Jeffery Suchard, MD jsuchard@uci.edu | |
| Principal Investigator: Jeff Suchard, MD | |
| Loma Linda University | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Sarah Pearl SPearl@llu.edu | |
| Principal Investigator: Sean Bush, MD | |
| University of California San Diego | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Alicia Minns abminns01@yahoo.com | |
| Principal Investigator: Rick Clark, MD | |
| San Diego Children's Hospital | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Alicia Minns abminns10@yahoo.com | |
| Principal Investigator: Rick Clark, MD | |
| United States, Colorado | |
| University of Colorado Hospital | Recruiting |
| Aurora, Colorado, United States, 80010 | |
| Contact: Torie Anderson, MPH victoria.anderson@rmpdc.org | |
| Principal Investigator: Kennon Heard, MD | |
| Denver Health and Hospital Authority | Recruiting |
| Denver, Colorado, United States, 80204 | |
| Contact: Torie Anderson, MPH victoria.anderson@rmpdc.org | |
| Principal Investigator: Kennon Heard, MD | |
| United States, Florida | |
| Cape Coral Hospital | Recruiting |
| Cape Coral, Florida, United States, 33990 | |
| Contact: Michael Schultz, MD | |
| Principal Investigator: Michael Schultz, MD | |
| University of Florida, Department of Emergency Medicine | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Kelly Jackman, PhD, MT (ASCP) 352-265-5911 jackman@ufl.edu | |
| Principal Investigator: David Meurer, MD | |
| United States, Louisiana | |
| LSU Health Sciences | Recruiting |
| Shreveport, Louisiana, United States, 71106 | |
| Contact: Kim Hutchinson KSmit9@lsuhsc.edu | |
| Principal Investigator: Thomas Arnold, MD | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Silas Bussman, MPH SiBussman@salud.unm.edu | |
| Principal Investigator: Steve Seifert, MD | |
| United States, Texas | |
| Texas Tech - West Texas Regional Poison Center | Recruiting |
| El Paso, Texas, United States, 79905 | |
| Contact: Sal Baeza SBaeza@thomasoncares.org | |
| Principal Investigator: John Haynes, MD | |
| United States, Virginia | |
| University of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Lea Becker LHB2K@hscmail.mcc.virginia.edu | |
| Principal Investigator: Chris Holstege, MD | |
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
No publications provided
| 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 |
| Last Updated: | May 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013