Evaluation of Therapeutic Effect of 0.5 mg Colchicine and... | NCT00723268

Studies
Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae

NCT00723268

Sponsor

Mashhad University of Medical Sciences

Status

Unknown status

Last Update Posted

Jul 29, 2008Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Oral Aphthae

Interventions

Prednisolone
Colchicine

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
286293

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Aug 2008Estimated

Completion Date

Not provided

First Submitted Date

Jul 24, 2008

First Submission Date that Met QC Criteria

Jul 25, 2008

First Posted Date

Jul 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2008

Last Update Posted Date

Jul 29, 2008Estimated

Name	Class
University of Tehran	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Treatment of recurrent aphthous stomatitis (RAS) remains, to date, empirical and non-specific. The main goals of therapy are to minimize pain and functional disabilities as well as decrease inflammatory reactions and frequency of recurrences.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prednisolone	Active Comparator		Drug: Prednisolone
Colchicine	Active Comparator		Drug: Colchicine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prednisolone	Drug	5MG Prednisolone per day for 3 months	Prednisolone

Measure	Description	Time Frame
frequency of ulcers		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mashhad Dental school		Mashhad	Razavi Khorasan Province	91735	Iran

Condition Browse Module

MeSH Terms

ID	Term
D005536	Foot-and-Mouth Disease
D019226	Oral Ulcer

Ancestor Terms

ID	Term
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011239	Prednisolone
D003078	Colchicine

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided