The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism

NCT00247078 | Completed Phase 2 DMC

• 1 other identifier: AR-03/02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.the investigational antivenom is more promptly effective at alleviating the pain associated with a widow spider bite than routine management with opioid pain medication
2. 2.the investigational antivenom is as safe a treatment as opioid pain medication in treating patients with a widow spider bite.

Conditions

Arachnidism; Latrodectism

Keywords

black; widow; spider; antivenom

Outcome Measures

Primary Outcomes (1)

• between-treatment groups difference in pain intensity (pre- and post-treatment)

  within first two hours

Secondary Outcomes (2)

• between-treatment groups difference in proportion of treatment failures (absence of pain relief or return to hospital)

  within 24 hours after discharge from emergency department

• between-treatment groups difference in incidence of drug-related adverse events.

  onset of adverse events within 21 days

Study Arms (2)

1

EXPERIMENTAL

Patients with moderate or severe pain due to Black Widow envenomation

Biological: widow spider antivenom

2

PLACEBO COMPARATOR

Patients with moderate to severe pain due to Black Widow envenomation

Biological: Placebo

Interventions

widow spider antivenom BIOLOGICAL

3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans

Also known as: Analatro

1

Placebo BIOLOGICAL

2

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patient presents for treatment within 72 hours from time of symptoms onset
• clinical diagnosis of widow spider envenomation
• patient has moderate to severe pain intensity

You may not qualify if:

• history of significant cardiac, respiratory, hepatic, or renal disease
• distracting injury or chronic pain syndrome that would obscure pain intensity assessment
• history of asthma or known sensitivity to fentanyl, morphine, diazepam, or equine serum
• pregnant or lactating

Sponsors & Collaborators

• Instituto Bioclon S.A. de C.V.: lead
• Rocky Mountain Poison and Drug Center: collaborator

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Spider Bites

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Richard C Dart, MD PhD

  Rocky Mountain Poison and Drug Center

  PRINCIPAL INVESTIGATOR

• Walter Garcia, MD

  Instituto Bioclon S.A. de C.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: November 1, 2005
• Study Start: October 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: December 1, 2006
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

US (1)