NCT00247078 is a Phase 2 clinical trial of widow spider antivenom in Arachnidism, sponsored by Instituto Bioclon S.A. de C.V..

Who is sponsoring NCT00247078?

NCT00247078 is sponsored by Instituto Bioclon S.A. de C.V..

What drugs are being tested in NCT00247078?

Interventions in NCT00247078: widow spider antivenom, Placebo.

What condition does NCT00247078 study?

NCT00247078 studies Arachnidism, Latrodectism.

Is NCT00247078 still recruiting?

NCT00247078 is currently completed. Last updated 18 March 2016.

Last reviewed 2016-03-18 · How we verify

NCT00247078

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 18 March 2016

What this trial tests

Phase 2 trial testing widow spider antivenom in Arachnidism in 24 participants. Completed in 1 December 2006.

Timeline

1 October 2005

Primary endpoint
1 October 2006

1 December 2006

Quick facts

Lead sponsor	Instituto Bioclon S.A. de C.V.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	24
Start date	1 October 2005
Primary completion	1 October 2006
Estimated completion	1 December 2006
Sites	1 location across United States

Drugs / interventions tested

widow spider antivenom — full drug profile →
Placebo

Conditions studied

Arachnidism — all drugs for Arachnidism →
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 Arachnidism or 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.

between-treatment groups difference in pain intensity (pre- and post-treatment)
Time frame: within first two hours

Sponsor's own description

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. 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. the investigational antivenom is as safe a treatment as opioid pain medication in treating patients with a widow spider bite.

Publications & conference data

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

Verify or expand the search:

Other Instituto Bioclon S.A. de C.V. trials

Trials by the same sponsor.

NCT01336660 — A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco · Phase 2, PHASE3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00247078 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Instituto Bioclon S.A. de C.V.
Last refreshed: 18 March 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00247078.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing