- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00438048
A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment
Xerostomy Treatment in Patients With Sjogren's Syndrome in Chile :A Double Blind Control Trial Comparing Orally Pilocarpine Drops and Artificial Saliva
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Region Metropolitana
-
Santiago, Region Metropolitana, Chile
- Unidad Docente Asociada Dermatologia. Escuela de MEdicina Pontificia Universidad Catolica de Chile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: a,b
Compare Pilocarpine and Artificial saliva
|
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:
5ml 3 times daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine on a subjetive manner wich treatment is better fot patients.
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Cristian Vera-Kellet, MD, UDA Dermatologia, Escuela de Medicina, Pontificia Universidad Catolica de Chile
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Lacrimal Apparatus Diseases
- Arthritis, Rheumatoid
- Salivary Gland Diseases
- Dry Eye Syndromes
- Sjogren's Syndrome
- Xerostomia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Cholinergic Agonists
- Miotics
- Muscarinic Agonists
- Pilocarpine
Other Study ID Numbers
- CAVK-130108245-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Xerostomia
-
Cathrine RahbekDanish Cancer Society; DLHM - Danish Society for Mouth and Throat Cancer; Danish...Active, not recruitingXerostomia Following Radiotherapy | Xerostomia Following in Neck Ore Head After CancersurgeryDenmark
-
Institute of Oncology LjubljanaUniversity Medical Centre Ljubljana; University of Ljubljana; Blood Transfusion...Not yet recruitingXerostomia Following RadiotherapySlovenia
-
Catholic University of the Sacred HeartSunstar Italiana SRL.CompletedXerostomia | Xerostomia Following RadiotherapyItaly
-
Qazvin University Of Medical SciencesImam Khomeini HospitalCompletedRadiation-Induced XerostomiaIran, Islamic Republic of
-
Bedford Hospital NHS TrustUnknownXerostomia | Xerostomia Due to Radiotherapy | Xerostomia Due to Hyposecretion of Salivary Gland
-
Institut de Terapia Regenerativa TissularUnknownXerostomia Due to RadiotherapySpain
-
MeiraGTx, LLCActive, not recruitingRadiation-induced XerostomiaUnited States, Canada
-
Thomas KuhntVerband Deutscher DruckkammerzentrenTerminatedRadiation-induced XerostomiaGermany
-
Laboratoires CARILENEDERMSCAN-PHARMASCAN GROUP in charge of data analysisCompleted
Clinical Trials on pilocarpine
-
Wills EyeCompleted
-
Emory UniversityGeorgia Institute of TechnologyCompleted
-
Glaukos CorporationCompletedDry Eye Disease | Kerato Conjunctivitis SiccaUnited States
-
Glaukos CorporationCompletedPresbyopiaUnited States
-
Samsung Medical CenterUnknownCataract | PresbyopiaKorea, Republic of
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyCompletedHead and Neck Cancer | XerostomiaUnited States, Canada
-
Alcon ResearchCompletedAngle-closure GlaucomaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedBreast Cancer | Vaginal DrynessUnited States
-
Isfahan University of Medical SciencesActive, not recruiting