Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan F. Yepes DDS, MD,, Indiana University
ClinicalTrials.gov Identifier:
NCT01690052
First received: April 6, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
Dry Mouth
Drug: Cevimeline
Drug: Pilocarpine

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690052

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: Juan F Yepes, DDS, MD, DrPH Indiana University
  More Information

No publications provided

Responsible Party: Juan F. Yepes DDS, MD,, Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01690052     History of Changes
Other Study ID Numbers: 9999
Study First Received: April 6, 2011
Results First Received: December 16, 2012
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympathomimetics

ClinicalTrials.gov processed this record on August 21, 2014