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| Sponsored by: |
Instituto Bioclon S.A. de C.V. |
|---|---|
| Information provided by: | Instituto Bioclon S.A. de C.V. |
| ClinicalTrials.gov Identifier: | NCT00247078 |
Purpose
The purpose of this study is to compare the safety and effectiveness of an investigational antivenom and the current standard of care (pain management with opioid analgesics) for treating patients with a widow spider bite. The working hypotheses are as follows:
| Condition | Intervention | Phase |
|---|---|---|
|
Arachnidism Latrodectism |
Biological: widow spider antivenom Biological: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Efficacy and Safety of Aracmyn® [Antivenin Latrodectus (Black Widow)Equine Immune F(ab)2], in Patients With Systemic Latrodectism: A Phase II, Multi-Center, Randomized, Double-Blind Trial |
| Enrollment: | 24 |
| Study Start Date: | October 2005 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Patients with moderate or severe pain due to Black Widow envenomation
|
Biological: widow spider antivenom
3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans
|
|
2: Placebo Comparator
Patients with moderate to severe pain due to Black Widow envenomation
|
Biological: Placebo |
The purpose of this randomized, double-blind, multi-center phase II trial is to examine the safety and efficacy of Aracmyn® [Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2], a new antivenom, for treatment of patients envenomed by the widow spider. Twenty-four subjects will be randomized to receive either the study drug or control (normal saline) through intravenous (IV) infusion. Following infusion, subjects will be monitored for changes in pain and clinical signs during a two-hour observation period. A standard dose of IV fentanyl will be offered to all subjects as pain medication at specific intervals following treatment. Vital signs, blood samples, and pain intensity scores (using a visual analog scale, VAS) will be collected before and after the infusion, as well as during the observation period. This study uses a treatment failure protocol, which involves administration of Merck Antivenin to subjects who do not obtain adequate pain relief from the study drug or control. Primary efficacy and safety endpoints for this 12-month trial will be improvement in pain intensity and clinical signs and incidence of adverse events, respectively.
Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Colorado | |
| Denver Health and Hospital Authority | |
| Denver, Colorado, United States, 80204 | |
| Principal Investigator: | Richard C Dart, MD PhD | Rocky Mountain Poison and Drug Center |
| Study Director: | Walter Garcia, MD | Instituto Bioclon S.A. de C.V. |
More Information
| Responsible Party: | Instituto Bioclon ( Walter Garcia, MD ) |
| Study ID Numbers: | AR-03/02 |
| Study First Received: | October 28, 2005 |
| Last Updated: | June 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00247078 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
black widow spider antivenom |
|
Antivenins Immunologic Factors Poisoning |
Disorders of Environmental Origin Bites and Stings Arachnidism |
|
Antivenins Immunologic Factors Physiological Effects of Drugs Poisoning |
Disorders of Environmental Origin Bites and Stings Arachnidism Pharmacologic Actions |