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 range18 Years – 65 Years
SexALL
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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.
✕. 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.
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
✕. 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.