ArachnidismPhase 2NCT00247078
The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism
A Phase 2 study testing widow spider antivenom in people with Arachnidism and Latrodectism, run by Instituto Bioclon S.A. de C.V. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Arachnidism, Latrodectism
- What is being tested?
- widow spider antivenom
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this 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
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.
Read the 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.
- Conditions
- Arachnidism, Latrodectism
- Being tested
- widow spider antivenom, Placebo
- Keywords
- black, widow, spider, antivenom
- Medical subject headings
- Spider Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
widow spider antivenomBiological
Also called Analatro
3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with moderate or severe pain due to Black Widow envenomation Receives: Biological: widow spider antivenom |
| 2 | Placebo comparator | Patients with moderate to severe pain due to Black Widow envenomation Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
between-treatment groups difference in pain intensity (pre- and post-treatment)
Measured: within first two hours
Secondary outcomes (2)
between-treatment groups difference in proportion of treatment failures (absence of pain relief or return to hospital)
Measured: within 24 hours after discharge from emergency department
between-treatment groups difference in incidence of drug-related adverse events.
Measured: onset of adverse events within 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArachnidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Bioclon S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rocky Mountain Poison and Drug Center
- Responsible party
- Sponsor
- Investigators
- Richard C Dart, MD PhD, Principal investigator, Rocky Mountain Poison and Drug CenterWalter Garcia, MD, Study director, Instituto Bioclon S.A. de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247078
- Sponsor's protocol ID
- AR-03/02
- Status last verified
- Mar 2016
- First submitted
- 28 Oct 2005
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00247078
- Acronym / sponsor ID
- AR-03/02
- Conditions
- Arachnidism, Latrodectism
- Keywords
- black, widow, spider, antivenom
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Instituto Bioclon S.A. de C.V.Industry (pharma, biotech, devices)
- Collaborators
- Rocky Mountain Poison and Drug Center
- Study start
- Oct 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: widow spider antivenomPatients with moderate or severe pain due to Black Widow envenomation |
| 2 | Placebo comparator | Biological: PlaceboPatients with moderate to severe pain due to Black Widow envenomation |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| widow spider antivenomAlso: Analatro3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans | Biological | 1 |
| Placebo | Biological | 2 |
Primary outcome
between-treatment groups difference in pain intensity (pre- and post-treatment)
Time frame: within first two hours
2 secondary outcomes
between-treatment groups difference in proportion of treatment failures (absence of pain relief or return to hospital)
Time frame: within 24 hours after discharge from emergency department
between-treatment groups difference in incidence of drug-related adverse events.
Time frame: onset of adverse events within 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard C Dart, MD PhD principal investigator
Rocky Mountain Poison and Drug Center
Walter Garcia, MD study director
Instituto Bioclon S.A. de C.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing widow spider antivenom in people with Arachnidism and Latrodectism, run by Instituto Bioclon S.A. de C.V. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
between-treatment groups difference in pain intensity (pre- and post-treatment) (time frame: within first two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.