NCT00723268

Brief Summary

The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Last Updated

July 29, 2008

Status Verified

July 1, 2008

Enrollment Period

1.3 years

First QC Date

July 24, 2008

Last Update Submit

July 28, 2008

Conditions

Oral Aphthae

Keywords

Oral ulcers

Outcome Measures

Primary Outcomes (1)

  • frequency of ulcers

    1 year

Study Arms (2)

Prednisolone

ACTIVE COMPARATOR
Drug: Prednisolone

Colchicine

ACTIVE COMPARATOR
Drug: Colchicine

Interventions

PrednisoloneDRUG

5MG Prednisolone per day for 3 months

Prednisolone
ColchicineDRUG

0.5 MG Colchicine per day for 3 months

Colchicine

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Confirmation of clinical diagnosis of aphthae
  • Having the experience of oral aphthae at least once in a month
  • Two weeks wash out periods after the last treatment

You may not qualify if:

  • History of any systemic disease
  • Using drugs which affect immune system
  • Pregnancy and breast feeding
  • Aphthous related syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mashhad Dental school

Mashhad, Khorasan Razavi, 91735, Iran

Location

MeSH Terms

Conditions

Foot-and-Mouth DiseaseOral Ulcer

Interventions

PrednisoloneColchicine

Condition Hierarchy (Ancestors)

Picornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsAnimal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAlkaloidsHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

May 1, 2007

Primary Completion

August 1, 2008

Last Updated

July 29, 2008

Record last verified: 2008-07

Locations

IR(1)