Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

• ClinicalTrials.gov Identifier: NCT01690052
• Recruitment Status: Completed
• First Posted: September 21, 2012
• Results First Posted: August 6, 2014
• Last Update Posted: June 4, 2018
• Sponsor: University of Kentucky
• Information provided by (Responsible Party): Joel Thompson, PhD, University of Kentucky

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dry Mouth	Drug: Cevimeline; Drug: Pilocarpine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Cevimeline; Cevimeline vs Pilocarpine	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.
Active Comparator: Pilocarpine; Pilocarpine vs. Cevimeline	Drug: Pilocarpine; Cevimlenine Vs Pilocarpine, cross over design, 4 weeks, one week wash out

Outcome Measures

Primary Outcome Measures :

1. 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.

Other Outcome Measures:

1. Adverse Events [ Time Frame: four weeks ]
   Adverse events related to the combination and order of study medication will be measured

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Kentucky

University of Kentucky Orofacial Pain Center College of Dentistry

Lexington, Kentucky, United States, 40536

Sponsors and Collaborators

University of Kentucky

Investigators

• Principal Investigator: Joel Thompson, PhD; University of Kentucky

More Information

• Responsible Party: Joel Thompson, PhD, PRS administrator, University of Kentucky
• ClinicalTrials.gov Identifier: NCT01690052
• Other Study ID Numbers: 9999
• First Posted: September 21, 2012
• Results First Posted: August 6, 2014
• Last Update Posted: June 4, 2018
• Last Verified: May 2018

Keywords provided by Joel Thompson, PhD, University of Kentucky:

dry mouth

Additional relevant MeSH terms:

Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Pilocarpine; Cevimeline; Miotics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Muscarinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympathomimetics