Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Formulario MAgistral Farmacias Ahumada | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a,b | Active Comparator | Compare Pilocarpine and Artificial saliva |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pilocarpine | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine on a subjetive manner wich treatment is better fot patients. | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cristian Vera-Kellet, MD | UDA Dermatologia, Escuela de Medicina, Pontificia Universidad Catolica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad Docente Asociada Dermatologia. Escuela de MEdicina Pontificia Universidad Catolica de Chile | Santiago | Santiago Metropolitan | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17043506 | Background | 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 Sjogren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study. J Clin Rheumatol. 2004 Aug;10(4):169-77. doi: 10.1097/01.rhu.0000135553.08057.21. | |
| 16323968 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010862 | Pilocarpine |
| D012464 | Saliva, Artificial |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D009067 | Mouthwashes |
| D001697 | Biomedical and Dental Materials |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Artificial Saliva | Drug | 5ml 3 times daily |
|
|
| Al-Hashimi I. Xerostomia secondary to Sjogren's syndrome in the elderly: recognition and management. Drugs Aging. 2005;22(11):887-99. doi: 10.2165/00002512-200522110-00001. |
| 15863819 | Background | Masters KJ. Pilocarpine treatment of xerostomia induced by psychoactive medications. Am J Psychiatry. 2005 May;162(5):1023. doi: 10.1176/appi.ajp.162.5.1023. No abstract available. |
| 15111631 | Background | Gotrick 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. doi: 10.1177/154405910408300508. |
| 15093850 | Background | Hendrickson RG, Morocco AP, Greenberg MI. Pilocarpine toxicity and the treatment of xerostomia. J Emerg Med. 2004 May;26(4):429-32. doi: 10.1016/j.jemermed.2003.09.013. |
| 15012873 | Background | Solans R, Bosch JA, Selva A, Simeon CP, Fonollosa V, Vilardell M. [Usefulness of oral pilocarpin therapy in the treatment of xerostomia and xerophthalmia in patients with primary Sjogren's syndrome]. Med Clin (Barc). 2004 Feb 28;122(7):253-5. doi: 10.1016/s0025-7753(04)75314-2. Spanish. |
| 14644860 | Background | 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 Sjogren's syndrome: a randomised 12 week controlled study. Ann Rheum Dis. 2003 Dec;62(12):1204-7. doi: 10.1136/ard.2002.003889. |
| 17000452 | Result | Wu CH, Hsieh SC, Lee KL, Li KJ, Lu MC, Yu CL. Pilocarpine hydrochloride for the treatment of xerostomia in patients with Sjogren's syndrome in Taiwan--a double-blind, placebo-controlled trial. J Formos Med Assoc. 2006 Oct;105(10):796-803. doi: 10.1016/S0929-6646(09)60266-7. |
| 16759558 | Result | Brito-Zeron P, Ramos-Casals M, Nardi N, Font J. [Results of the treatment with oral pilocarpine in 100 patients with primary Sjogrens syndrome]. Med Clin (Barc). 2006 Apr 29;126(16):637. doi: 10.1157/13087738. No abstract available. Spanish. |
| 16700739 | Result | Aframian DJ, Helcer M, Livni D, Markitziu A. Pilocarpine for the treatment of salivary glands' impairment caused by radioiodine therapy for thyroid cancer. Oral Dis. 2006 May;12(3):297-300. doi: 10.1111/j.1601-0825.2005.01195.x. |
| 16424527 | Result | Aragona P, Di Pietro R, Spinella R, Mobrici M. Conjunctival epithelium improvement after systemic pilocarpine in patients with Sjogren's syndrome. Br J Ophthalmol. 2006 Feb;90(2):166-70. doi: 10.1136/bjo.2005.078865. |
| D008420 |
| Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |