Safety and Efficacy Study of GB001 Recombinant Peptide Spray in Subjects With Mild Recurrent Apht… (NCT06429566) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety and Efficacy Study of GB001 Recombinant Peptide Spray in Subjects With Mild Recurrent Aphthous Ulcers
China120 participantsStarted 2023-07-18
Plain-language summary
This trial is conducted in China. The purpose is to evaluate the efficacy, Pharmacokinetics (PK) profile, immunogenicity and safety of GB001 recombinant peptide spray in adults with mild recurrent aphthous ulcer.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. It meets the diagnostic criteria for mild recurrent Aphthous ulcer in the fifth edition of Oral Mucosa published by People's Medical Publishing House in 2020.
. 18≤ age ≤65 years old, gender is not limited.
. Patients with untreated target ulcer onset ≤48 hours at the time of screening.
. VAS score of target ulcer irritation pain ≥3 points, 2mm≤ length diameter of target ulcer ≤10mm.
. Subjects and their sexual partners agree to use effective contraception during the study period and for at least 30 days after the study ends.
. Sign a written informed consent, and be able to comply with the visit and related procedures stipulated in the program.
Exclusion criteria
. The diagnosis was severe aphthous ulcer, herpetic aphthous ulcer, acute herpetic gingivitis stomatitis, traumatic ulcer, cancerous ulcer, tuberculous ulcer, syphilitic ulcer, necrotic salivate metaplasia, Behcet disease and other diseases or drug induced ulcers.
. Patients with suppurative tonsillitis or other painful lesions in the mouth, such as pericoronitis, pulpitis, periapical inflammation, etc., affecting the pain score of target ulcer.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Target ulcer healing rate for patients in day 6
Timeframe: Day 6
2
Subjects self-rated the time it took for irritation pain to disappear
. Target ulcer is affected by residual root, residual crown, denture, prosthesis, orthodontic device and other stimulating factors in the corresponding parts of the target ulcer.
. The ulcer is located in the lingual frenulum, the back wall of the pharynx and other parts, and its size is not easy to measure.
. Those who plan to perform other oral treatments during the trial that affect the determination of drug effectiveness and safety.
. Smokers \> 20 cigarettes/day or betel nut lovers in the past 3 months.
. People who have used painkillers or drugs that may affect the efficacy of pain observation within 24 hours before the first administration, such as sedatives, anti-allergy drugs, non-steroidal anti-inflammatory drugs, etc.
. Patients who have used antibiotics or antiviral drugs locally or systematically within 1 week before screening.