Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	16 and over	Pharmaceutical / Industry	CAN-NCIC-SC16 P-UPJOHN-CAN-NCIC-SC16, NCT00003686, SC16

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.

Entry Criteria

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

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)

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

David Warr, MD, Protocol chair		Ph: 416-946-2260 Email: david.warr@uhn.on.ca

Registry Information
Official Title		A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth
Trial Start Date		1998-12-03
Registered in ClinicalTrials.gov		NCT00003686
Date Submitted to PDQ		1998-12-04
Information Last Verified		2007-05-31

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