NCT02049112
Completed
Phase 4
Phase 4 Study Evaluating Efficacy, Safety and Acceptability of Treatment With a New Salivary Equivalent Compared to Two Moisturizing Mouth Sprays on the Improvement of Dry Mouth Symptoms and Oral Comfort in Patients With Xerostomia.
Unither Pharmaceuticals, France1 site in 1 country210 target enrollmentJanuary 2012
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Xerostomia
- Sponsor
- Unither Pharmaceuticals, France
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Dry mouth discomfort
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of our new oral salivary equivalent in the relief of signs and symptoms related to mouth dryness as compared to two distinct moisturizing currently marketed oral sprays (Aequasyal® & Biotene®) in patients with xerostomia due to chronic hyposalivation.
Detailed Description
National, multicentre, randomised, active controlled, crossover, open-label study using a 3-latin-square design. 200 evaluable patients have been recruited
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18 years or more,
- •Clinical diagnosis of xerostomia by a severe reduction of salivation, as detected by patient's answers to few specific questions and measured by saliva volume at screening visit (test of saliva weight absorbed ≤ 0.1g/min)
- •Any medical condition or treatment leading to a severe reduction of salivation related to either:
- •Head and neck radiation therapy for cancer,
- •Gougerot-Sjögren syndrome
- •Medications known to induce xerostomia (psychotropic drugs, antihypertensive drugs)
- •Dehydration, hypothyroidism, Parkinson's disease and/or diabetes mellitus
- •Female patients must be post-menopausal or using a highly effective method for avoidance of pregnancy throughout the whole study duration, if childbearing potential.
- •Able to understand and comply with the protocol procedures
- •Willing and able to give their written informed consent
Exclusion Criteria
- •Known hypersensitivity to one of the study products or to one of their components
- •Any planned change in dosing of all known medications inducing mouth dryness
- •Concomitant treatment for xerostomia symptoms without a scheduled 3 to 7-day withdrawal window
- •Oral candidiasis as diagnosed by a microbiological test obtained from an unstimulated whole saliva sample until 3-week period from disease release
- •Oral ulceration
- •Alcohol (\>2 glasses of wine/day), smoking (\>10 cigarettes/day), caffeine and/or theine intake (\>4 cups/day)
- •Patients unable to fill out the questionnaires or to comply with the study protocol
- •Dental infection
- •Patients participating to another clinical trial at the time of the study entry or within 30 days prior to study enrolment
- •Life-threatening condition at the time of the study
Outcomes
Primary Outcomes
Dry mouth discomfort
Time Frame: 14 days
Patient evaluation through the completion of a self rated 100 mm long VAS score. Anchor points of the VAS score will be 0 representing the absence of any dry mouth symptoms and 100 representing the worst imaginable picture of dry mouth discomfort
Secondary Outcomes
- Taste perversion(14 days)
- Medical device acceptability(14 days)
- Medical device safety assessment(14 days)
- Mouth burning sensation(14 days)
- Speech difficulties(14 days)
- Chewing difficulties(14 days)
- Swallowing difficulties(14 days)
Study Sites (1)
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