The Efficacy and Safety of Aracmyn in Patients With Syste... | NCT00247078

Studies
The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism

NCT00247078

Sponsor

Instituto Bioclon S.A. de C.V.

Status

Completed

Last Update Posted

Mar 22, 2016Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

Arachnidism
Latrodectism

Interventions

widow spider antivenom
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Oct 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Oct 28, 2005

First Submission Date that Met QC Criteria

Oct 28, 2005

First Posted Date

Nov 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2016

Last Update Posted Date

Mar 22, 2016Estimated

Name	Class
Rocky Mountain Poison and Drug Center	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
widow spider antivenom	Biological	3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
between-treatment groups difference in pain intensity (pre- and post-treatment)		within first two hours

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Denver Health and Hospital Authority		Denver	Colorado	80204	United States

Condition Browse Module

MeSH Terms

ID	Term
D001098	Spider Bites

Ancestor Terms

ID	Term
D001733	Bites and Stings
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided