NCT02982577

Effect of Pilocarpine in Patients With Xerostomia

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Xerostomia

Interventions

Type	Name	Description
DRUG	Pilocarpine	Spray the basis of 1.54% pilocarpine, 3 times per day (each 8 hours), during 90 days.
OTHER	Spray without Pilocarpine	Spray without pilocarpine, 3 times per day (each 8 hours), during 90 days.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2016-12-05
• Last updated: 2016-12-05

Locations

1 site across 1 country: Brazil