NCT00438048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

1.5 years

First QC Date

February 20, 2007

Last Update Submit

May 21, 2008

Conditions

Primary SjogrenSecondary SjogrenXerostomia

Keywords

PilocarpineArtificial salivaXerostomiaXerostomyPrimary SjogrenSecondary Sjogren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Determine on a subjetive manner wich treatment is better fot patients.

    12 weeks

Study Arms (1)

a,b

ACTIVE COMPARATOR

Compare Pilocarpine and Artificial saliva

Procedure: pilocarpineDrug: Artificial Saliva

Interventions

pilocarpinePROCEDURE

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

Also known as: Artificial saliva
a,b
Artificial SalivaDRUG

5ml 3 times daily

Also known as: pilocarpine
a,b

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patiens over 18 years, with primary or secondary Sjogren's Syndrome and xerostomia.

You may not qualify if:

  • Patiens with cardiac, pulmonary, renal, gastric diseases,
  • Patients with diabetes, glaucoma, Multipleesclerosis,
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad Docente Asociada Dermatologia. Escuela de MEdicina Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (11)

  • 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.

    PMID: 17043506BACKGROUND

  • 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.

    PMID: 16323968BACKGROUND

  • 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.

    PMID: 15863819BACKGROUND

  • 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.

    PMID: 15111631BACKGROUND

  • 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.

    PMID: 15093850BACKGROUND

  • 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.

    PMID: 15012873BACKGROUND

  • 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.

    PMID: 14644860BACKGROUND

  • 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.

    PMID: 17000452RESULT

  • 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.

    PMID: 16759558RESULT

  • 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.

    PMID: 16700739RESULT

  • 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.

    PMID: 16424527RESULT

MeSH Terms

Conditions

Xerostomia

Interventions

PilocarpineSaliva, Artificial

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsMouthwashesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Cristian Vera-Kellet, MD

    UDA Dermatologia, Escuela de Medicina, Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

November 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

CL(1)