A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment
Study Details
Study Description
Brief Summary
The purpose of this study is to assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by SS in a multicenter, doubleblind, controlled trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Title:
Xerostomy treatment in patients with Sjogren's syndrome in Chile :A double blind control trial comparing orally Pilocarpine drops and Artificial Saliva
Authors:
Cristian Vera Kellet, Mirtha Cifuentes Mutinelli. Affiliations: Pontificia Universidad Catolica de Chile
BACKGROUND Sjogren's syndrome (SS) is characterized by diminished exocrine secretions with the resultant xerostomia and xerophthalmia due to slowly progressive infiltration of lacrimal and salivary glands by inflamatory cells.
OBJECTIVE: To assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by SS in a multicenter, doubleblind, controlled trial.
SUBJECTS AND METHODS After providing written informed consent, 72 patients with primary or secondary SS and clinically significant dry mouth and dry eyes will be randomized to receive either 5-mg pilocarpine drops, or artificial saliva 3 times daily for 12 weeks. Global evaluation and subjective responses of patients will be assessed by questionnaires with visual analog scales or categorical checkboxes. All patients will be submited to anxiety and psicological test before and after 12 weeks. Whole-mouth salivary flow and lacrimal flow will be measured using Schirmer test.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: a,b Compare Pilocarpine and Artificial saliva |
Procedure: pilocarpine
or secondary symptomatic SS with clinically significant dry mouth were randomized to receive either 5 mg oral Pilocarpine solution (5ml) or artificial saliva (5 ml) 3 times a day for 12 weeks
Other Names:
Drug: Artificial Saliva
5ml 3 times daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- To assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by SS in a multicenter, doubleblind, controlled trial. [12 weeks]
Secondary Outcome Measures
- Determine on a subjetive manner wich treatment is better fot patients. [12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patiens over 18 years, with primary or secondary Sjogren's Syndrome and xerostomia.
Exclusion Criteria:
-
Patiens with cardiac, pulmonary, renal, gastric diseases,
-
Patients with diabetes, glaucoma, Multipleesclerosis,
-
Pregnant women.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unidad Docente Asociada Dermatologia. Escuela de MEdicina Pontificia Universidad Catolica de Chile | Santiago | Region Metropolitana | Chile |
Sponsors and Collaborators
- Pontificia Universidad Catolica de Chile
- Formulario MAgistral Farmacias Ahumada
Investigators
- Principal Investigator: Cristian Vera-Kellet, MD, UDA Dermatologia, Escuela de Medicina, Pontificia Universidad Catolica de Chile
Study Documents (Full-Text)
None provided.More Information
Publications
- Al-Hashimi I. Xerostomia secondary to Sjögren's syndrome in the elderly: recognition and management. Drugs Aging. 2005;22(11):887-99. Review.
- Götrick B, Akerman S, Ericson D, Torstenson R, Tobin G. Oral pilocarpine for treatment of opioid-induced oral dryness in healthy adults. J Dent Res. 2004 May;83(5):393-7.
- Hendrickson RG, Morocco AP, Greenberg MI. Pilocarpine toxicity and the treatment of xerostomia. J Emerg Med. 2004 May;26(4):429-32.
- Masters KJ. Pilocarpine treatment of xerostomia induced by psychoactive medications. Am J Psychiatry. 2005 May;162(5):1023.
- Papas AS, Sherrer YS, Charney M, Golden HE, Medsger TA Jr, Walsh BT, Trivedi M, Goldlust B, Gallagher SC. Successful Treatment of Dry Mouth and Dry Eye Symptoms in Sjögren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study. J Clin Rheumatol. 2004 Aug;10(4):169-77.
- Solans R, Bosch JA, Selva A, Simeón CP, Fonollosa V, Vilardell M. [Usefulness of oral pilocarpin therapy in the treatment of xerostomia and xerophthalmia in patients with primary Sjögren's syndrome]. Med Clin (Barc). 2004 Feb 28;122(7):253-5. Spanish.
- Tsifetaki N, Kitsos G, Paschides CA, Alamanos Y, Eftaxias V, Voulgari PV, Psilas K, Drosos AA. Oral pilocarpine for the treatment of ocular symptoms in patients with Sjögren's syndrome: a randomised 12 week controlled study. Ann Rheum Dis. 2003 Dec;62(12):1204-7.
- CAVK-130108245-1