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Effect of Pilocarpine in Patients With Xerostomia

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ClinicalTrials.gov Identifier: NCT02982577
Recruitment Status : Unknown
Verified November 2016 by Raony Môlim de Sousa Pereira, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Raony Môlim de Sousa Pereira, University of Sao Paulo

Brief Summary:
The purpose of this study is to evaluate the effectiveness of a spray the basis of pilocarpine on salivary flow of patients with xerostomia, by radiation therapy, and primary Sjögren's Syndrome treated at the Clinics Hospital of Faculty of Medicine of Ribeirão Preto (HCFMRP-USP), and its impact on quality of life.

Condition or disease Intervention/treatment Phase
Xerostomia Drug: Pilocarpine Other: Spray without Pilocarpine Phase 4

Detailed Description:
There will be two groups: Group 1 (G1) - will use a spray with pilocarpine for three months and after a washout period of a month, use a spray without pilocarpine for another three months; Group 2 (G2) - will use a spray without pilocarpine for three months and after a washout period of a month, use a spray with pilocarpine for another three months (in a randomized, controlled, duble blind and crossover study). Participants will be submitted to OHIP-14, Xerostomia Inventory (XI) and salivary flow measurement before the start of therapy - baseline (T0), one (T2), two (T3) and three (T4) months after starting the use of spray, after washout, crossover occurs and the same parameters are measured for the same periods (T0', T2', T3' and T4'), and is measured one hour after the saliva (T1 and T1') baseline.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pilocarpine in Patients With Xerostomia
Study Start Date : April 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Experimental: Pilocarpine
Spray with Pilocarpine
Drug: Pilocarpine
Spray the basis of 1.54% pilocarpine, 3 times per day (each 8 hours), during 90 days.
Other Name: Pilocarpine spray

Placebo Comparator: Placebo
Spray without Pilocarpine
Other: Spray without Pilocarpine
Spray without pilocarpine, 3 times per day (each 8 hours), during 90 days.
Other Name: Placebo




Primary Outcome Measures :
  1. Salivary flow [ Time Frame: baseline, 1 hour after baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures ]
    measured by stimulated salivation


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures ]
    measured by Oral Health Impact Profile (OHIP-14)

  2. Xerostomia grade [ Time Frame: baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures ]
    measured by Xerostomia Inventory



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age equal or superior to 18 years;
  • Both genders;
  • Lucid and without diagnosis of any psychiatric disorder;
  • Diagnosed with head and neck cancer and treated for a period of up to 5 years with radiotherapy where the major salivary glands (parotid, submandibular and sublingual) were included in the radiation field;
  • Primary Sjögren's syndrome with the diagnosis made by the American-European criteria.

Exclusion Criteria:

  • Sensitivity to pilocarpine
  • Secondary Sjögren's syndrome;
  • Type II diabetes mellitus;
  • AIDS;
  • pregnant or lactating women;
  • Glaucoma;
  • Uncontrolled asthma;
  • Chronic obstructive pulmonary disease;
  • Renal diseases;
  • Severe cardiovascular diseases;
  • Gastrointestinal disorders;
  • Hepatic insufficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982577


Contacts
Contact: Raony MS Pereira, MSc +55 16 981275221 raonymolimsp@hotmail.com
Contact: Ana CF Motta, PhD +55 16 33154067 anacfm@usp.br

Locations
Brazil
University of São Paulo Recruiting
Ribeirao Preto, São Paulo, Brazil, 14040904
Contact: Raony MS Pereira, MSc    +55 16 981275221    raonymolimsp@hotmail.com   
Contact: Ana CF Motta, PhD    +55 16 33154067    anacfm@usp.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Camila Tirapelli, PhD University of São Paulo

Publications of Results:

Other Publications:
Responsible Party: Raony Môlim de Sousa Pereira, MSc, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02982577     History of Changes
Other Study ID Numbers: 27765714.0.0000.5419
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Raony Môlim de Sousa Pereira, University of Sao Paulo:
Xerostomia
Pilocarpine
Quality of life

Additional relevant MeSH terms:
Xerostomia
Mouth Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action