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Trial registered on ANZCTR


Registration number
ACTRN12609000499280
Ethics application status
Approved
Date submitted
2/06/2009
Date registered
23/06/2009
Date last updated
23/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
An clinical evaluation of penicillin G potassium in the treatment of minor recurrent aphthous ulceration in a Chinese cohort: a randomized, double-blinded, placebo and blank controlled, multicenter clinical trial
Scientific title
The efficacy of penicillin G potassium in reducing aphthous ulcer pain and lesion size in a Chinese cohort: a randomized, double-blinded, placebo and blank controlled, multicenter clinical trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
minor recurrent aphthous ulceration. 236976 0
Condition category
Condition code
Oral and Gastrointestinal 237266 237266 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 50mg of penicillin G potassium troches were topically applied by subjects themselves 4 times a day for 4 days.
Intervention code [1] 236747 0
Treatment: Drugs
Comparator / control treatment
patients in placebo controlled group were adminiatrated placebo troche, which presented similar figure and flavor and contained same ingredients as penicillin G potassim troche except for the penicillin G potassium.One placebo troche was topically applied 4 times a day for 4 days. Meanwhile, a blank controlled group was set, in which patients got no treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 238143 0
the effectiveness of topical application of Penicillin G potassium troches in reducing aphthous ulcer pain and lesion size
Timepoint [1] 238143 0
the index were measured at the fisrt visit and the mornings of day 3, day 4, day 5, day 6
Secondary outcome [1] 242354 0
Incidence of allergic reactions. The symptom of chest tightness, dizzy, dyspnea, and sign of pale face and sharp drop of blood pressure would occur in the condition of hypersensitivity to penicillin G potassium.The symptom and sign were observed by patients and investigators.
Timepoint [1] 242354 0
30 minutes following the application of troche

Eligibility
Key inclusion criteria
1. Males and females aged 12 years or older, who can follow doctor’ advice.
2. Willingness to participate and sign the informed consent forms.
3. History of minor recurrent ulcers, with expectation that their ulcers normally take 5 or more days to resolve without treatment.
4. Presenting with 1 to 3 aphthous ulcers (less than 48 hours’ duration) with a size no greater than 10 mm in diameter.
5. Negative reaction to penicillin skin test.
6. Normal sense of pain, without anesthesia or paresthesia.
7. Ulcers must be in locations easily accessible for evaluation and treatment.
Minimum age
12 Years
Maximum age
73 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of allergies to penicillin, cephalosporins or B (beta)- lactamantibiotics.
2. Pregnancy and lactation (Urine human chorionic gonadotrophin-positive)
3. Concurrent oral fungal/viral infections.
4. Other concurrent clinical conditions posing a risk to the patient or study, including active tuberculosis or other infectious diseases spread by respiratory droplets, unstable or uncontrolled medical conditions, and a present/recent history of cocaine/heroin drug or alcohol abuse.
5. Ulcers as a manifestation of a systemic disease process such as ulcerative colitis, Crohn’s disease, Behcet’s syndrome, or serious anemia.
6. Treatment with systemic steroid, oral retionoids or other immunomodulatory agents within 1 month of study entry.
7. Use of non-steroidal anti-inflammatory drug, acetaminophen, or oral antihistamines within 1 month of study entry.
8. Treatment with any oral topical medication within 2 weeks of study entry.
9. Treatment of the ulcer with any preparation or medication within 48 hours of study entry.
10. Treatment with asystemic antibiotic within 2 weeks of study entry.
11. Dental surgery within 2 weeks of study entry.
12. Orthodontic braces or retainer that might come in to contact with the ulcer.
13. Use of chewing tobacco products, smoking pipes, or smoking cigars. Cigarette smokers will be accepted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1824 0
China
State/province [1] 1824 0

Funding & Sponsors
Funding source category [1] 237140 0
Government body
Name [1] 237140 0
the 10th 5-Year Plan of National Key Technologies R&D Program in China (No.2004BA720A28)
Address [1] 237140 0
15, FuXingYilu, Bejing, China
100862
Country [1] 237140 0
China
Funding source category [2] 237141 0
Government body
Name [2] 237141 0
Scientific Research Foundation for Medicine and Health from Health Bureau of Zhejiang Province (No. 2007A132).
Address [2] 237141 0
148 NanShanLu, Hangzhou,
Zhejiang, China
310002
Country [2] 237141 0
China
Primary sponsor type
Hospital
Name
West China Hospital, Sichuan University
Address
14 RenMinNanLu, Section 3, Chengdu Sichuan, China
Country
China
Secondary sponsor category [1] 4593 0
Hospital
Name [1] 4593 0
Affiliated Hospital, Chengdu Traditional Chinese Medicine University
Address [1] 4593 0
17 ShiErQiaoLu, Chengdu Sichuan, China
Country [1] 4593 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Recurrent aphthous ulcer is chronic inflammatory disease without definite etiology. The effectiveness of topical antibiotics has been validated in the treatment of recurrent aphthous ulcer, such as chlorhexidine, tetracycline, aureomycin, and chlortetracycline. Although they could dramatically reduce pain
and healing time of ulceration, their side effects could not be neglected. For these
shortcomings, it is urgent to explore some other effective and safe antibiotics to treat
recurrent aphthous ulcer.
Interestingly, penicillin G potassium, which is a narrow-spectrum antibiotic with
known bacteriocidal effects against oral bacteria, has been proved effective and safe in treating recurrent aphthous ulcer when topically applied in America. But no comfirmative trial has be conducted in other ethnic groups.

We conducted this randomized, double-blined, placebo and blank controlled,
multicenter clinical trial, in order to clinically determine both the effectiveness and safety of penicillin G potassium troches when applied topically for the treatment of recurrent minor aphthous ulcer in a Chinese cohort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29689 0
Address 29689 0
Country 29689 0
Phone 29689 0
Fax 29689 0
Email 29689 0
Contact person for public queries
Name 12936 0
Qianming Chen
Address 12936 0
State Key Laboratory of Oral Disease, West China College of Stomatology, Sichuan University.14 RenMinNanLu, Section 3, Chengdu,Sichuan , China
Country 12936 0
China
Phone 12936 0
86-28-85503480
Fax 12936 0
Email 12936 0
qmchen@scu.edu.cn
Contact person for scientific queries
Name 3864 0
Qianming Chen
Address 3864 0
State Key Laboratory of Oral Disease, West China College of Stomatology, Sichuan University.14 RenMinNanLu, Section 3, Chengdu,Sichuan , China
Country 3864 0
China
Phone 3864 0
86-28-85503480
Fax 3864 0
Email 3864 0
qmchen@scu.edu.cn

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary