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Trial registered on ANZCTR


Registration number
ACTRN12619000593134
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
17/04/2019
Date last updated
22/04/2020
Date data sharing statement initially provided
17/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of the safety and efficacy of LBS-020 in patients with mouth dryness following radiotherapy
Scientific title
A Multi-centre, Double-blind, Randomised Study of the Safety and Efficacy of Orally-applied LBS-020 in Patients with Moderate to Severe Radiation-induced Xerostomia with a History of Previously-treated Head and Neck Cancer
Secondary ID [1] 297909 0
None
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Xerostomia 312294 0
Condition category
Condition code
Oral and Gastrointestinal 310847 310847 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 310897 310897 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consisits of a treatment period of 7 days (+1 day visit window). Eligible subjects randomised to the treatment arm will self-administer (orally rinse, swish, and gargle for 60 seconds, and expectorate) at home. Subjects will self-administer 8 mL LBS-020 (150ug/ml) orally five times a day every 3h ± 2h, preferably before meals. Subjects will be provided with sufficient product (vials) for self-administering five times a day for 8 days. At end of treatment phase, subjects will return all unused product. Furhter, subjects will be asked to complete a daily diary for monitoring of the treatment phase.
Intervention code [1] 314131 0
Treatment: Drugs
Comparator / control treatment
The control treatment consisits of a treatment period of 7-8 days. Eligible subjects randomised to the control arm will self-administer (orally rinse, swish, and gargle for 60 seconds, and expectorate) at home. Subjects will self-administer 8 mL vehicle control orally five times a day every 3h ± 2h, preferably before meals.
Control group
Placebo

Outcomes
Primary outcome [1] 319681 0
VAS score assessing subject's mouth dryness
Timepoint [1] 319681 0
Visit 3 (end of treament period)
Secondary outcome [1] 369138 0
Treatment-emergent adverse events. The investigator will report all directly observed adverse events and all adverse events spontaneously reported by a study subject. Each study subject will be questioned about adverse events at each scheduled study visit. The type of question asked should be open-ended (e.g., “Have you had any new health problems?” or similar type of query). Examples of Adverse Events include significant or unexpected worsening or exacerbation of the condition/indication under study; exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity (grade) of the condition; New conditions detected or diagnosed after investigational product administration even though they may have been present prior to the start of the study; Signs, symptoms, or the clinical sequelae associated with a suspected interaction of the investigational product with a concomitant medication; Signs, symptoms, or the clinical sequelae associated with a suspected overdose of either investigational product or a concurrent medication.
Timepoint [1] 369138 0
Visit 2 (baseline), 3 (end of treatment period) and 4 (4-5- days post-treatment period)
Secondary outcome [2] 369139 0
VAS score assessing subject's ability to speak due to dryness
Timepoint [2] 369139 0
Visit 2 (baseline), 3 (end of treatment period) and 4 (4-5- days post-treatment period)
Secondary outcome [3] 369140 0
VAS score assessing subject's ability to swallow due to dryness
Timepoint [3] 369140 0
Visit 2 (baseline), 3 (end of treatment period) and 4 (4-5- days post-treatment period)
Secondary outcome [4] 369141 0
VAS score assessing subject's throat dryness
Timepoint [4] 369141 0
Visit 2 (baseline), 3 (end of treatment period) and 4 (4-5- days post-treatment period)
Secondary outcome [5] 369142 0
VAS score assessing subject's mouth and tongue discomfort due to dryness. This is a composite secondary outcome.
Timepoint [5] 369142 0
Visit 2 (baseline), 3 (end of treatment period) and 4 (4-5- days post-treatment period)

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data collected during the study will be included in by subject data listings. Descriptive
statistical methods will be used to summarise data from this study. Unless stated otherwise, the term descriptive statistics refers to number of subjects (n), mean, median, standard deviation (SD), standard error of the mean (SEM), minimum and maximum for continuous data and frequencies and percentages for categorical data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2019
Actual
23/05/2019
Date of last participant enrolment
Anticipated
26/08/2019
Actual
17/01/2020
Date of last data collection
Anticipated
13/09/2019
Actual
3/02/2020
Sample size
Target
50
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 13570 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 13571 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 26216 0
2298 - Waratah
Recruitment postcode(s) [2] 26217 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 302421 0
Commercial sector/Industry
Name [1] 302421 0
Lubris, LLC
Country [1] 302421 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Lubris LLC
Address
c/- Alira Health
1 Grant Street, Suite 400
Framingham, MA, 01702 USA
Country
United States of America
Secondary sponsor category [1] 302329 0
None
Name [1] 302329 0
Address [1] 302329 0
Country [1] 302329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303092 0
Hunter New England HREC
Ethics committee address [1] 303092 0
Ethics committee country [1] 303092 0
Australia
Date submitted for ethics approval [1] 303092 0
31/01/2019
Approval date [1] 303092 0
26/03/2019
Ethics approval number [1] 303092 0
19/02/20/3.06

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92438 0
Dr Chris Wratten
Address 92438 0
Radiation Oncology
Calvary Mater Newcastle
Corner of Edith and Platt Streets
Waratah, NSW 2298
Country 92438 0
Australia
Phone 92438 0
+61 240143631
Fax 92438 0
Email 92438 0
chris.wratten@calvarymater.org.au
Contact person for public queries
Name 92439 0
Harry Barnett
Address 92439 0
Lubris LLC,
c/- Alira Health
1 Grant Street, Suite 400
Framingham, MA, 01702 USA
Country 92439 0
United States of America
Phone 92439 0
+1(0)6179471749
Fax 92439 0
Email 92439 0
hbarnett@lubris.net
Contact person for scientific queries
Name 92440 0
Harry Barnett
Address 92440 0
Lubris LLC,
c/- Alira Health
1 Grant Street, Suite 400
Framingham, MA, 01702 USA
Country 92440 0
United States of America
Phone 92440 0
+1(0)6179471749
Fax 92440 0
Email 92440 0
hbarnett@lubris.net

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be publicly shared. Data will be collected collectively and analysis and publication will be done on data sets rather than IPD. IPD will be available at site only, and will be accessible only to the site staff, sponsor representative or delegate (e.g. study monitor) and regulatory authority (if applicable) on site.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.