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,, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01690052
First received: April 6, 2011
Last updated: September 17, 2012
Last verified: September 2012
  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:
  • Increase saliva production in ml. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    The primary outcome measure is the increase of stimulated and non-stimulated saliva in ml from the baseline record. At each appointment, 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: 12
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, 4 weeks, one week wash out
Active Comparator: Pilocarpine Drug: Pilocarpine
Cevimlenine Vs Pilocarpine, cross over design, 4 weeks, one week wash out

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dry mouth
  Contacts and Locations
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, MPH University of Kentucky
  More Information

No publications provided

Responsible Party: Juan F. Yepes DDS, MD,, Medical IRB Vice-Chair, University of Kentucky
ClinicalTrials.gov Identifier: NCT01690052     History of Changes
Other Study ID Numbers: 9999
Study First Received: April 6, 2011
Last Updated: September 17, 2012
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 April 17, 2014