Oral AphthaePhase 2NCT00723268
Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
A Phase 2 study testing Prednisolone and Colchicine in people with Oral Aphthae, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Aphthae
- What is being tested?
- Prednisolone and Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- May 2007to Aug 2008
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- History of any systemic disease
- Using drugs which affect immune system
- Pregnancy and breast feeding
- Aphthous related syndromes
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.
Read the 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.
- Conditions
- Oral Aphthae
- Being tested
- Prednisolone, Colchicine
- Keywords
- Oral ulcers
- Medical subject headings
- Foot-and-Mouth Disease, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
5MG Prednisolone per day for 3 months
ColchicineDrug
0.5 MG Colchicine per day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Active comparator | Not described Receives: Drug: Prednisolone |
| Colchicine | Active comparator | Not described Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of ulcers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startMay 2007
- Primary completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral AphthaeStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723268
- Sponsor's protocol ID
- 286293
- Other IDs
- 286293
- Status last verified
- Jul 2008
- First submitted
- 24 Jul 2008
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
- ClinicalTrials.gov ID
- NCT00723268
- Acronym / sponsor ID
- 286293
- Conditions
- Oral Aphthae
- Keywords
- Oral ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Collaborators
- University of Tehran
- Study start
- May 2007
- Primary completion
- Aug 2008 (estimated)
- First posted
- 28 Jul 2008 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Active comparator | Drug: Prednisolone |
| Colchicine | Active comparator | Drug: Colchicine |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- History of any systemic disease
- Using drugs which affect immune system
- Pregnancy and breast feeding
- Aphthous related syndromes
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 |
|---|---|---|
| Prednisolone5MG Prednisolone per day for 3 months | Drug | Prednisolone |
| Colchicine0.5 MG Colchicine per day for 3 months | Drug | Colchicine |
Primary outcome
frequency of ulcers
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prednisolone and Colchicine in people with Oral Aphthae, run by Mashhad University of Medical Sciences at 1 site in Iran.
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: status not confirmed, as of the sponsor's last update on 29 Jul 2008. 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 Iran. 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. 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?
Results are not available in the source record.
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?
frequency of ulcers (time frame: 1 year). 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 29 Jul 2008.