Efficacy of Cevimeline Versus 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
|Official Title:||Efficacy of Cevimeline vs. Pilocarpine in the Secretion of Saliva|
- Change From Baseline in Saliva Production in ml. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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.
- Number of Participants With Adverse Effects Associated With the Medications [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]We will record the number and type of side effects associated with each medication.
|Study Start Date:||January 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Cevimeline
Cevimeline vs Pilocarpine
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.
Active Comparator: Pilocarpine
Pilocarpine vs. Cevimeline
Cevimlenine Vs Pilocarpine, cross over design, 4 weeks, one week wash out
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690052
|United States, Kentucky|
|University of Kentucky Orofacial Pain Center College of Dentistry|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Juan F Yepes, DDS, MD, DrPH||Indiana University|