Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva
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|ClinicalTrials.gov Identifier: NCT01690052|
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : August 6, 2014
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dry Mouth||Drug: Cevimeline Drug: Pilocarpine||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy of Cevimeline vs. Pilocarpine in the Secretion of Saliva|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||July 2010|
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
- Change From Baseline in Saliva Production in ml. [ Time Frame: 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.
- Adverse Events [ Time Frame: four weeks ]Adverse events related to the combination and order of study medication will be measured
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690052
|United States, Kentucky|
|University of Kentucky Orofacial Pain Center College of Dentistry|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Joel Thompson, PhD||University of Kentucky|