NCT00657540: BWSP3

A Phase III Multicenter Clinical Trial of Analatro® [Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2] in Patients With Systemic Latrodectism

Completed Phase 3 Results posted Last updated 7 March 2018

What this trial tests

Phase 3 trial testing Analatro in Latrodectism in 60 participants. Completed in 1 October 2014.

Timeline

1 October 2009

Primary endpoint
1 October 2014

1 October 2014

Quick facts

Lead sponsor	Instituto Bioclon S.A. de C.V.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 October 2009
Primary completion	1 October 2014
Estimated completion	1 October 2014
Sites	16 locations across United States

Drugs / interventions tested

• Analatro — full drug profile →
• Saline

Conditions studied

• Latrodectism — all drugs for Latrodectism →

Sponsor

Instituto Bioclon S.A. de C.V. — full company profile →

Who can join

10 and older, any sex, with Latrodectism. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With Treatment Failure
  Time frame: From start of Dose 1 infusion to 48 hours post treatment
  The primary efficacy endpoint for this study was the number 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

Sponsor's own description

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%).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.