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Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003686
Recruitment Status : Terminated (Terminated due to poor accrual.)
First Posted : August 17, 2004
Last Update Posted : April 3, 2020
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Brief Summary:

RATIONALE: Pilocarpine may help to relieve dry mouth in patients receiving opioids for cancer therapy. It is not yet known whether pilocarpine is more effective than no further treatment for this condition.

PURPOSE: Randomized phase III trial to determine the effectiveness of pilocarpine in treating patients who have dry mouth caused by opioids.

Condition or disease Intervention/treatment Phase
Oral Complications Quality of Life Drug: pilocarpine hydrochloride Drug: Placebo Phase 3

Detailed Description:

OBJECTIVES: I. Evaluate the effectiveness of daily oral pilocarpine versus placebo in relieving dry mouth due to the ongoing use of an opioid for cancer related pain at 2 weeks by comparing proportion of patients with at least one response during the 2 week period, time of first response, and duration of first response. II. Evaluate the adverse effects of pilocarpine in these patients. III. Evaluate whether constipation, sedation, poor appetite, and nausea are ameliorated by pilocarpine in these patients. IV. Evaluate the effect of pilocarpine on quality of life of this patient group. V. Determine the timing and duration of the effect of pilocarpine in this patient population.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients receive either oral pilocarpine four times daily (arm I) or oral placebo four times daily (arm II) for 4 weeks. At the end of the 4 weeks, all patients are given the option to receive oral pilocarpine. Quality of life is assessed 2 days prior to randomization, after 2 weeks of treatment, and after 4 weeks of treatment.

PROJECTED ACCRUAL: There will be 60 patients accrued into this study within 18 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth
Actual Study Start Date : May 22, 1998
Actual Primary Completion Date : November 1, 2007
Actual Study Completion Date : December 15, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Active Comparator: Pilocarpine Drug: pilocarpine hydrochloride
Pilocarpine 5 mg po qid x 4 weeks

Placebo Comparator: Placebo Drug: Placebo
Placebo 5 mg po qid x 4 weeks

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 10 years ]
    To evaluate, using a 100 mm VAS, the effectiveness of oral pilocarpine 5 mg qid in relieving dry mouth due to the ongoing use of an opioid for cancer related pain at 2 weeks (day 15). This will include comparing the proportion of at least one response during the 2 week period, time to first response and duration of first response.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Complaint of dry mouth with ALL the following characteristics: At least 1 week in duration Attributed by the treating physician to an opioid Severity rating at least 20 mm on a 100 mm visual analog scale Must be receiving routine (i.e., not just as needed) dosing with one of the following opioids: morphine, hydromorphone, transdermal fentanyl, methadone, or oxycodone Intent to continue opioid therapy at the same or higher dose over the first 2 weeks that the patient is receiving protocol treatment

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-3 Life expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Calcium less than 29.9 mg/dL Cardiovascular: No symptomatic congestive heart failure or hypotension (systolic blood pressure less than 100 mm Hg) Pulmonary: No obstructive pulmonary disease (asthma, chronic bronchitis, or chronic obstructive pulmonary disease) Other: No known sensitivity to pilocarpine No active oral candidiasis No Sjogren's syndrome No acute iritis or narrow-angle glaucoma Not pregnant or nursing Effective contraception required of all fertile patients Must be fluent and possess sufficient cognitive ability to complete quality of life questionnaires in either English or French without assistance from a caregiver

PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to a field encompassing the parotid glands At least 1 week since prior radiotherapy to the chief site of pain No concurrent radiotherapy to chief site of pain for 2 weeks following randomization Surgery: Not specified Other: No concurrent tricyclic antidepressants (amitriptyline, nortriptyline, desipramine, or imipramine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003686

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Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Humber River Regional Hospital
Weston, Ontario, Canada, M9N 1N8
Sponsors and Collaborators
NCIC Clinical Trials Group
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Study Chair: David Warr, MD Princess Margaret Hospital, Canada
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: NCIC Clinical Trials Group Identifier: NCT00003686    
Other Study ID Numbers: SC16
CAN-NCIC-SC16 ( Other Identifier: PDQ )
P-UPJOHN-CAN-NCIC-SC16 ( Other Identifier: UPJOHN )
CDR0000066788 ( Other Identifier: PDQ unique registration number )
First Posted: August 17, 2004    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
oral complications
quality of life
Additional relevant MeSH terms:
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Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action