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Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

Information source: University of Kentucky
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dry Mouth

Intervention: Cevimeline (Drug); Pilocarpine (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Kentucky

Official(s) and/or principal investigator(s):
Juan F Yepes, DDS, MD, DrPH, Principal Investigator, Affiliation: Indiana University

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.

Clinical Details

Official title: Efficacy of Cevimeline vs. Pilocarpine in the Secretion of Saliva

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Saliva Production in ml.

Secondary outcome: Number of Participants With Adverse Effects Associated With the Medications

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.

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Potential candidates with the diagnosis of moderate-severe xerostomia were identified from the Oral Medicine Clinic at the University Of Kentucky College Of Dentistry, or self referrals in response to IRB approved study announcements. Enrollment required no clinical evidence of oral lesions, subjective perception of dry mouth and less than 2 mL of saliva collected in 5 minutes without stimulation. Exclusion criteria included patients with non controlled chronic obstructive pulmonary disease (COPD), depression, asthma, cardiac arrhythmias, glaucoma, and the current use of any medication with interactions with cevimeline and pilocarpine.

Locations and Contacts

University of Kentucky Orofacial Pain Center College of Dentistry, Lexington, Kentucky 40536, United States
Additional Information

Starting date: January 2009
Last updated: August 5, 2014

Page last updated: August 23, 2015

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