NCT00389259

Brief Summary

Organophosphate (OP) compounds are a major threat as chemical warfare agents or in terrorist act. OPs are also the active ingredient of many insecticides. Ingestion of insecticides is a common cause of death among people who commit suicide in developing countries. OPs poisoning also frequently occurs after accidental exposure to agricultural OPs and in children as a result of unintentional ingestion. The use of competitive inhibitors of acetylcholine other than atropine for patient with organophosphate (OP) poisoning is controversial. Because scopolamines' ability to cross the blood brain barrier is better than atropine, it has been suggested that scopolamine should be used OP poisoned patients who have central nervous system (CNS) manifestations. However there is controversy regarding its potential benefit in the treatment of organophosphate poisoning in humans. To the best of our knowledge there are no randomised controlled studies on the use of scopolamine in humans. This prospective randomised controlled study is aimed to determine whether adding scopolamine to the standard treatment of atropine and oximes in patients with CNS symptoms of OP poisoning improve the outcome.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 5, 2011

Status Verified

March 1, 2010

First QC Date

October 17, 2006

Last Update Submit

April 4, 2011

Conditions

Neurotoxicity Syndromes

Keywords

InsecticidesOrganophosphateScopolaminerandomized control studyOrganophosphate or carbamate intoxication

Outcome Measures

Primary Outcomes (3)

  • Improvement in neurological status as measured by the Glasgow Coma Scale

    1 week

  • Duration of seizures.

    1 week

  • Number of days on ventilator

    1 week

Secondary Outcomes (10)

  • Total cumulative dose of atropine

    1 week

  • Need for benzodiazepines

    1 week

  • Number of days in the ICU

    2 weeks

  • Adverse effects and complications

    2 weeks

  • Neurological assessment at discharge

    2 weeks

  • +5 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

IV Scopolamine 0.25mg in adults and 0.006mg/kg in children Q4h

Drug: Placebo

B

PLACEBO COMPARATOR

IV Look alike drug Q 4h

Drug: Placebo

Interventions

PlaceboDRUG

IV placebo q4h

AB

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: 2- 60 years
  • At least two of the following three criteria:
  • Known exposure to an organophosphate or carbamate insecticide in the last 72 hours.
  • Symptoms and signs typical to organophosphate poisoning involving at least two systems (gastrointestinal, respiratory, skin, eyes,) See appendix
  • Low levels of plasma butyrylcholinesterase (less than 50% of the lower normal range )
  • CNS involvement in the first 72 hours after exposure: determined by finding at least one of the following major criteria or at least two of the minor criteria
  • Major criteria for CNS involvement:
  • Seizures
  • Extrapyramidal or Parkinson like symptoms
  • Decreased level of consciousness (GCS\< 12)
  • Minor criteria for CNS involvement:
  • GCS 14-12
  • Confusion
  • Hallucinations

You may not qualify if:

  • Hypersensitivity to scopolamine
  • Glaucoma, narrow-angle (angle-closure)
  • Tachyarrhythmias, congestive heart failure
  • Obstructive gastrointestinal disease
  • Myasthenia Gravis
  • Reflux esophagitis
  • Ulcerative colitis
  • Known obstructive uropathy
  • Pregnancy
  • Patient or legal guardian unable to give informed consent (see comment under ethics)
  • Severe co-morbidity (multi-trauma, advanced cancer, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Hospital

Haifa, Israel

Location

MeSH Terms

Conditions

Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System DiseasesPoisoningChemically-Induced Disorders

Study Officials

  • Eran Kozer, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

October 1, 2007

Study Completion

December 1, 2009

Last Updated

April 5, 2011

Record last verified: 2010-03

Locations

IL(1)