A study of the safety and efficacy of LBS-020 in patients with mouth dryness following radiotherapy
- Conditions
- XerostomiaOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonCancer - Head and neck
- Registration Number
- ACTRN12619000593134
- Lead Sponsor
- ubris LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 37
1. Diagnosis of radiation-induced xerostomia
2. History of treated head and neck cancer with no evidence of active cancer
3. At least 6 months from last cancer treatment
4. A score >= 40 on a 100mm VAS assessing the subject’s mouth dryness (anchors: not dry at all; very dry)
5. Age 18 years or older
1. Evidence of an active oral infection
2. History or presence of oral surface disorders not related to dry mouth
3. Use of any oral topical medication other than the study medications for the treatment of oral diseases including artificial saliva during the study period
4. History of any oral surgery within 180 days prior to the screening visit. Oral surgery will not be allowed during the study treatment period and elective oral surgery procedures should not be planned during the duration of the follow-up period.
5. Presence or history of any oral or systemic disorder or condition that might significantly hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct of trial procedures
6. Known hypersensitivity to one of the components of the study or procedural medications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS score assessing subject's mouth dryness[Visit 3 (end of treament period)]
- Secondary Outcome Measures
Name Time Method