The effect and safety of Meditoxin® (Botulinum toxin) injection in chronic sialoadenitis

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0004028
• Lead Sponsor: Bundang CHA General Hospital

Brief Summary

All subjective symptoms decreased significantly until 1 month and then increased. However, at 6 months, all subjective symptoms were determined to be better than before injection. The unstimulated and stimulated salivary flow rate did not show a significant difference over time. No significant difference was noted in parotid gland volume or uptake on salivary SPECT–CT over time.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-04-22
• Results First Posted: 2020-10-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

The enrolled patient should comply with all of the following criteria.
1) Men and women over 20 and under 70
2) The patient who have experienced symptoms for more than 6 months
3) The patient who repeat 3 or more episodes of sialoadenitis
4) The patient who voluntarily decided to participate and signed the consent form before starting this clinical trial

Exclusion Criteria

Patients who fall under any of the following criteria are not allowed to register for this clinical trial.
1) Patients who have been confirmed to have a stone or tumor in the salivary gland by CT or MRI
2) Patients with salivary glands hypertrophy without pain or pressure sense
3) Patients who participated in other clinical trials within last 1 month
4) Patients with less than a longer period of five times the half-life of medicines in previous clinical trials
5) Patient who have the contraindication of Meditoxin
6) In addition to the above, patients who are deemed inappropriate for this trial by investigator

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Questionaire (frequency and intensity of pain, frequency and intensity of swelling);SPECT-CT (Single Photon Emission Computed Tomography-Computed Tomography)

Secondary Outcome Measures

Name	Time	Method
Salivary flow test