Exploratory Study in the Relief of Drug-induced Xerostomia Associated With Hyposialia

NCT ID: NCT02005328

Last Updated: 2014-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-02-28

Brief Summary

The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia associated with hyposialia, i.e. dryness of the mouth induced by a decrease of salivation (hyposialia) induced by chronic drug intake.

Conditions

Drug-induced Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

cross-over

Four periods separated by a wash out lasting up to 3 days at maximum. At each period, application of one product (twice). Duration of treatment period: From 4 to 13 days.

Group Type: EXPERIMENTAL

Tested product : DC161-DP0291

Intervention Type: DEVICE

Application of product in the mouth twice daily

Tested product : DC161-DP0292

Intervention Type: DEVICE

Application of product in the mouth twice daily

Tested product : DC161-DP0293

Intervention Type: DEVICE

Application of product in the mouth twice daily

Reference product: solution for oromucosal sprays

Intervention Type: DEVICE

Application of product in the mouth twice daily

Interventions

Tested product : DC161-DP0291

Application of product in the mouth twice daily

Intervention Type: DEVICE

Tested product : DC161-DP0292

Application of product in the mouth twice daily

Intervention Type: DEVICE

Tested product : DC161-DP0293

Application of product in the mouth twice daily

Intervention Type: DEVICE

Reference product: solution for oromucosal sprays

Application of product in the mouth twice daily

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male and female subjects,
• Adult subjects (≥18 years) taking drug(s) causing salivary hypofunction / xerostomia, for at least 1 week prior to study initiation and expected to continue without change during study
• Subjects with a complaint of dry mouth as assessed by a response of 40mm or greater on item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale (VAS) questions. (The VAS limits will be 0 representing normal [i.e. no dry mouth symptoms] and 100 representing "the worst imaginable" dry mouth symptoms). This score should also be met before the 1st product application, on P1 D1.
• Documented hyposalivation with test of resting saliva weight absorbed ≤ 0.5g/5 min at baseline

Exclusion Criteria

• Presence of disorders (bucco-dental disease, history of major medical/psychiatric illness or surgery, ... ) which, in the judgement of the investigator, may interfere with study implementation and/or study parameter assessment(s).
• Sjögren syndrome and related autoimmune diseases,
• Other medical causes of xerostomia (oral candidiasis).
• History of head and neck irradiation and cancer chemotherapy
• History of hypersensitivity to any of the components of the investigational products,
• History or current excessive use of alcohol,
• History of drug addiction,
• Presence of treatments for their dry mouth within 7 days prior to inclusion into the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Medicament

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Erfurt, , Germany

Countries

Germany

Other Identifiers

DC0161 BS 0 01

Identifier Type: -

Identifier Source: org_study_id

CIV-13-10-011648

Identifier Type: OTHER

Identifier Source: secondary_id