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Trial record 4 of 6 for:    CEVIMELINE

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
Sponsor:
Information provided by (Responsible Party):
Joel Thompson, PhD, University of Kentucky

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Mouth
Interventions Drug: Cevimeline
Drug: Pilocarpine
Enrollment 15
Recruitment Details Patients were recruited from the Salivary Gland Dysfunction Clinic at the U. of K. A cross-over double-blind randomized trial was designed. Two arms were assembled. First arm the SEQUENCE was cevimeline(C) then pilocarpine(P), and for the second the SEQUENCE was P then C. Each participant received the drug for 4 weeks with 1 week washout period.
Pre-assignment Details The total number of patients screened for the study was 28. Of 28 patients, 15 met the inclusion criteria
Arm/Group Title Cevimeline First, Then Pilocarpine Pilocarpine First, Then Cevimeline
Hide Arm/Group Description Cevimeline First then Pilocarpine: Cevimeline (30mg three times a day) for 4 weeks (First intervention period) and then pilocarpine (5 mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week. Pilocarpine First then Cevimeline: Pilocarpine (5 mg three times a day) for 4 weeks (first intervention period) and then Cevimeline (30mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
Period Title: FIRST INTERVENTION: 4 WEEKS
Started 7 8
Completed 6 6
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             2
Period Title: Washout Period of 1 Week
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: SECOND INTERVENTION: 4 WEEKS
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description

Two interventions were assembled:

For the first intervention, the SEQUENCE was cevimeline (30mg three times a day) for 4 weeks and then Pilocarpine (5 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week.

For the second intervention, the SEQUENCE was Pilocarpine (5mg three times a day) or 4 weeks and then Cevimeline (30 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
3
  20.0%
Male
12
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Change From Baseline in Saliva Production in ml.
Hide Description

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.

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cevimeline Pilocarpine
Hide Arm/Group Description:
Cevimeline 30mg administered three times a day in first intervention period or second intervention period for 4 weeks.
Pilocarpine 5 mg administered three times a day in either first intervention period or second intervention period
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ml
Unstimulated Saliva 1.41  (0.5) 3.93  (0.5)
Stimulated Saliva 5.31  (0.5) 10.34  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cevimeline, Pilocarpine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments The p-value is calculated from the ANOVA
2.Other Pre-specified Outcome
Title Adverse Events
Hide Description Adverse events related to the combination and order of study medication will be measured
Time Frame four weeks
Outcome Measure Data Not Reported
Time Frame The adverse events are reported per intervention (4 weeks with each medication)
Adverse Event Reporting Description No adverse events were presented in any of the intervention sequences
 
Arm/Group Title Cevimeline Then Pilocarpine (Intervention 1) Pilocarpine Then Cevimeline (Intervention 2)
Hide Arm/Group Description Cevimeline then pilocarpine One week washout period Pilocarpine then cevimeline One week washout period
All-Cause Mortality
Cevimeline Then Pilocarpine (Intervention 1) Pilocarpine Then Cevimeline (Intervention 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cevimeline Then Pilocarpine (Intervention 1) Pilocarpine Then Cevimeline (Intervention 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cevimeline Then Pilocarpine (Intervention 1) Pilocarpine Then Cevimeline (Intervention 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
There are limitations that affected this study. This is a pilot study with a relative low number of patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Juan F. Yepes DDS, MD, MPH, MS, DrPH, Associate Professor
Organization: Indiana University School of Dentistry
Phone: 317-944-9601
EMail: jfyepes@iupui.edu
Layout table for additonal information
Responsible Party: Joel Thompson, PhD, University of Kentucky
ClinicalTrials.gov Identifier: NCT01690052     History of Changes
Other Study ID Numbers: 9999
First Submitted: April 6, 2011
First Posted: September 21, 2012
Results First Submitted: December 16, 2012
Results First Posted: August 6, 2014
Last Update Posted: June 4, 2018