Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

NCT01690052 | Completed Results

• 1 other identifier: 9999
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Mouth

Keywords

dry mouth

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Saliva Production in ml.

  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.

  4 weeks

Other Outcomes (1)

• Adverse Events

  four weeks

Study Arms (2)

Cevimeline

ACTIVE COMPARATOR

Cevimeline vs Pilocarpine

Drug: Cevimeline

Pilocarpine

ACTIVE COMPARATOR

Pilocarpine vs. Cevimeline

Drug: Pilocarpine

Interventions

Cevimeline DRUG

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.

Cevimeline

Pilocarpine DRUG

Cevimlenine Vs Pilocarpine, cross over design, 4 weeks, one week wash out

Pilocarpine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (1)

University of Kentucky Orofacial Pain Center College of Dentistry

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Xerostomia

Interventions

cevimeline; Pilocarpine

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Limitations and Caveats

There are limitations that affected this study. This is a pilot study with a relative low number of patients.

Results Point of Contact

• Title: Juan F. Yepes DDS, MD, MPH, MS, DrPH, Associate Professor
• Organization: Indiana University School of Dentistry

jfyepes@iupui.edu

317-944-9601

Study Officials

• Joel Thompson, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRS administrator

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: September 21, 2012
• Study Start: January 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 4, 2018
• Results First Posted: August 6, 2014

Record last verified: 2018-05

Locations

US (1)