Effect of Pilocarpine in Patients With Xerostomia

November 30, 2016 updated by: Raony Môlim de Sousa Pereira, University of Sao Paulo
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ana CF Motta, PhD
  • Phone Number: +55 16 33154067
  • Email: anacfm@usp.br

Study Locations

  • Brazil
    • São Paulo
      • Ribeirao Preto, São Paulo, Brazil, 14040904
        • Recruiting
        • University of Sao Paulo
        • Contact:
        • Contact:
          • Ana CF Motta, PhD
          • Phone Number: +55 16 33154067
          • Email: anacfm@usp.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures
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
baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Director: Camila Tirapelli, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

November 27, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27765714.0.0000.5419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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