NCT00366067

Brief Summary

The purpose of this study was to determine whether antiepileptic drug phenytoin is effective in the treatment of chronic asthma in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

First QC Date

August 17, 2006

Last Update Submit

February 18, 2009

Conditions

Bronchial Asthma

Keywords

Bronchial asthmaPhenytoinAntiepileptic drugsEfficacy

Outcome Measures

Primary Outcomes (1)

  • At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms

Secondary Outcomes (1)

  • At 3 months of treatment: Difference in PEF pm-am (in %); The daily (daytime and night-time) symptoms scores; % of symptom free days during the treatment period; Use of other antiasthmatic medication

Interventions

PhenytoinDRUG

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients between 10 and 14, patients parents or supervisors must have given their informed consent before commencing the procedures specified in the protocol, indicating that they understand the objectives of the study and are willing to adhere to the procedures described in the protocol.
  • Patients able to use peak flow meters, to perform spirometry and to swallow capsules.
  • Patient aged between 4 and 14 years, males or females.
  • Out patients.
  • Patients with an established (i.e. at least 6 months) clinical history of asthma.
  • Absence of long-term remissions of asthma (lasting more than 1 month)
  • Poorly controlled asthma, due to various reasons.

You may not qualify if:

  • History or presence of cardiovascular, renal, neurologic, psychiatric, liver, immunologic, endocrine, infection or other diseases or dysfunctions if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
  • Patients with active tuberculosis with indication for treatment.
  • Patients with known allergy, side effects, intolerance/hypersensitivity to investigational drug
  • Patients currently using MAO inhibitors, tricyclic antidepressants, antiepileptic drugs, narcotic agents.
  • Patients between 10 and 14, parents or supervisor of patients unlikely, unable or unwilling to comply with the requirements of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Rea" Rehabilitation Centre

Tbilisi, 0160, Georgia

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Phenytoin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

HydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Merab Lomia, MD, PhD

    "Rea" Rehabilitation Centre

    PRINCIPAL INVESTIGATOR

  • Tamuna Tchelidze

    CRO Evidence

    PRINCIPAL INVESTIGATOR

  • Nana Zhorzholadze, MD

    "Rea" Rehabilitation Centre

    PRINCIPAL INVESTIGATOR

  • Manana Pruidze

    Centre of Chinese Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 18, 2006

Study Start

August 1, 2006

Study Completion

February 1, 2007

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

GE(1)