Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

Not Applicable

Completed

• Conditions: Dry Mouth
• Interventions: Drug: Cevimeline; Drug: Pilocarpine

• Registration Number: NCT01690052
• Lead Sponsor: University of Kentucky

Brief Summary

The main objectives were: 1) To determine the efficacy of both cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia, and 2) To compare the side-effects between the treatment for xerostomia with cevimeline and with pilocarpine.

Detailed Description

Pilocarpine is a cholinergic agonist with predominant muscarinic action.As such, it acts at muscarinic-cholinergic receptors found throughout the body and promotes fluid secretion. Due to this, one of the main side-effects of pilocarpine is an increased amount of sweating. Thus, not only are the salivary glands stimulated, but all of the body's exocrine glands' production is heightened. On the other hand, cevimeline is a drug with a high affinity for specific muscarinic receptors (M3) located on lachrymal and salivary gland epithelium. At least in theory, cevimeline will produce less side effects compared with pilocarpine because of the higher affinity for the muscarinic receptors located in the salivary glands. A limited number of human clinical trials in the efficacy of cevimeline and pilocarpine to increase the production of saliva and the side effects have been performed with no conclusive results.

The main purposes of this study were to determine the efficacy of cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia, and to compare the side-effects between these two medications.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-21
• Results First Submitted: 2012-12-16
• Results First Submitted QC: 2014-08-05
• Results First Posted: 2014-08-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cevimeline	Cevimeline	Cevimeline vs Pilocarpine
Pilocarpine	Pilocarpine	Pilocarpine vs. Cevimeline

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Saliva Production in ml.	4 weeks	The primary outcome measure was the change of stimulated and non-stimulated saliva in ml from the baseline record.; At each appointment (weekly), participants will provide 2 saliva samples to measure their current salivary output. The first measurement will be obtained by having the patient spit as much as he or she could into a cup for five minutes. The amount of saliva in ml will be recorded.; The second measurement will be obtained in a similar manner with the addition of having the patient chew on a block of unflavored wax. Patients will complete weekly questionnaires to help determine which side-effects they experience as they take the medications.

Trial Locations

Locations (1)

University of Kentucky Orofacial Pain Center College of Dentistry; 🇺🇸 Lexington, Kentucky, United States