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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cevimeline | Active Comparator | Cevimeline vs Pilocarpine |
|
| Pilocarpine | Active Comparator | Pilocarpine vs. Cevimeline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events related to the combination and order of study medication will be measured | four weeks |
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.
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| Name | Affiliation | Role |
|---|---|---|
| Joel Thompson, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Orofacial Pain Center College of Dentistry | Lexington | Kentucky | 40536 | United States |
The total number of patients screened for the study was 28. Of 28 patients, 15 met the inclusion criteria
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cevimeline First, Then Pilocarpine | 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. |
| FG001 | Pilocarpine First, Then Cevimeline | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FIRST INTERVENTION: 4 WEEKS |
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| Washout Period of 1 Week |
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| SECOND INTERVENTION: 4 WEEKS |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | ml | 4 weeks |
|
The adverse events are reported per intervention (4 weeks with each medication)
No adverse events were presented in any of the intervention sequences
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cevimeline Then Pilocarpine (Intervention 1) | Cevimeline then pilocarpine One week washout period |
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There are limitations that affected this study. This is a pilot study with a relative low number of patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juan F. Yepes DDS, MD, MPH, MS, DrPH, Associate Professor | Indiana University School of Dentistry | 317-944-9601 | jfyepes@iupui.edu |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C059240 | cevimeline |
| D010862 | Pilocarpine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| Pilocarpine | Drug | Cevimlenine Vs Pilocarpine, cross over design, 4 weeks, one week wash out |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Pilocarpine | Pilocarpine 5 mg administered three times a day in either first intervention period or second intervention period |
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| Other Pre-specified | Adverse Events | Adverse events related to the combination and order of study medication will be measured | Not Posted | four weeks | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Pilocarpine Then Cevimeline (Intervention 2) | Pilocarpine then cevimeline One week washout period | 0 | 12 | 0 | 12 | 0 | 12 |
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