NCT01690052

Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

Efficacy of Cevimeline vs. Pilocarpine in the Secretion of Saliva

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Kentucky · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Mouth

Interventions

Type	Name	Description
DRUG	Cevimeline	Cevimlenine Vs Pilocarpine, cross over design. Two sequences were evaluated "cevimeline first, then pilocarpine" and "pilocarpine first, then cevimeline". Each sequence was evaluated for 4 weeks with one week "washout" period in between both sequences. 15 patients were randomly assigned to a specific sequence by a research pharmacist independent from the study authors. The patients received 30mg of cevimeline three times a day and pilocarpine 5mg three times a day.
DRUG	Pilocarpine	Cevimlenine Vs Pilocarpine, cross over design, 4 weeks, one week wash out

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2012-09-21
• Last updated: 2018-06-04
• Results posted: 2014-08-06

Locations

1 site across 1 country: United States