Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CLINICAL EVALUATION OF THE EFFICACY OF AN INTRA ORAL SPRAY FOR PATIENTS WITH XEROSTOMIA

NCT04719091

Dry Mouth, Xerostomia.Hyaluronic Acid, Xylitol

COMPLETED NA

Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia

NCT00332618

Xerostomia

COMPLETED

Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects

NCT03005041

Xerostomia

COMPLETED NA

Exploratory Study in the Relief of Drug-induced Xerostomia Associated With Hyposialia

NCT02005328

Drug-induced Xerostomia

COMPLETED NA

Clinical Study New Gel for Xerostomia

NCT04184908

XEROSTOMIA

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Mouth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cevimeline

Cevimeline vs Pilocarpine

Group Type ACTIVE_COMPARATOR

Cevimeline

Intervention Type 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.

Pilocarpine

Pilocarpine vs. Cevimeline

Group Type ACTIVE_COMPARATOR

Pilocarpine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Pilocarpine

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No