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ID
Source
Brief title
Health condition
HEALTH
Sponsors and support
Intervention
Outcome measures
Primary outcome
Amlexanox oral adhesive pellicles significantly reduced ulcer size and alleviated ulcer pain.
Secondary outcome
Erythema exudation.
Background summary
Amlexanox has been developed as a 5% topical oral paste for the treatment of patients with RAS in most European countries. However, it is not available in China yet or has not been generally accepted in clinical treatment. To explore the effectiveness and safety of amlexanox oral adhesive pellicles in the treatment of minor recurrent aphthous ulcers, a randomized, blinded, placebo controlled, parallel, multicenter clinical study was designed. A total of 216 patients with MiRAU were recruited randomized to amlexanox or vehicle pellicles group. All patients were instructed to apply one pellicle to that identified ulcer 4 times a day (after meals and before bedtime) for 5 days (day 1 to day 5). The size and pain level of ulcers were measured and recorded on treatment days 0, 4 and 6. After five days treatment, amlexanox oral adhesive pellicles significantly reduced ulcer size and alleviated ulcer pain. None of the patients in the study was observed or reported to have any adverse experience. None of the hematologic values were considered clinically abnormal. There were also no laboratory differences between the 2 groups at baseline or day 6, and there were no significant changes over time.
Study objective
Amlexanox is not available in China yet or has not been generally accepted in clinical treatment. To explore the effectiveness of amlexanox oral adhesive pellicles in the treatment of minor recurrent aphthous ulcers.
Study design
Five days.
Intervention
Subjects were instructed to apply 1 pellicle to that identified ulcer 4 times a day for 5 days.
No. 14, Sec.3, Renminnan Road
Chengdu, Sichuan
Sichuan 610041
China
+86 28 85405251
qmchen@scu.edu.cn
No. 14, Sec.3, Renminnan Road
Chengdu, Sichuan
Sichuan 610041
China
+86 28 85405251
qmchen@scu.edu.cn
Inclusion criteria
1. Males and females aged 18-60 years old;
2. Willingness to participate and sign the informed consent forms;
3. Presenting with 1 to 5 aphthous ulcers (less than 72 hours duration) with a size no greater than 5 mm in diameter;
4. An expectation that their ulcers normally take 5 or more days to resolve without treatment;
5. Normal sense of pain, without anesthesia or paresthesia.
Exclusion criteria
1. A known history of serious drug hypersensitivities;
2. Pregnancy and lactation (Urine hCG-positive);
3. Concurrent clinical conditions that could pose a health risk to the subjects, including serious liver, kidney, and heart dysfunctions;
4. A history of an immunologic problem;
5. Ulcers as a manifestation of a systemic disease process such as ulcerative colitis, Crohns disease, Behcet¡s syndrome, or serious anemia;
6. Treatment with systemic steroid or other immunomodulatory agents within 1 month before the study entry;
7. Use of nonsteroidal anti-inflamatory drugs or oral antihistamines within 1 month prior to the study entry;
8. Treatment of the ulcer with any preparation or medication within 72 hours prior to the study entry;
9. Treatment with systemic antibiotics within 2 weeks prior to the study entry;
10. Attendance of any other clinical trials within 3 months prior to the study entry.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1630 |
| NTR-old | NTR1727 |
| Other | : N/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |