Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids

April 1, 2020 updated by: NCIC Clinical Trials Group

A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency
    • Ontario
      • Weston, Ontario, Canada, M9N 1N8
        • Humber River Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 120 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo 5 mg po qid x 4 weeks
ACTIVE_COMPARATOR: Pilocarpine
Drug: pilocarpine hydrochloride
Pilocarpine 5 mg po qid x 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Investigators

  • Study Chair: David Warr, MD, Princess Margaret Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 22, 1998

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

December 15, 2008

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 16, 2004

First Posted (ESTIMATE)

August 17, 2004

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC16
  • CAN-NCIC-SC16 (OTHER: PDQ)
  • P-UPJOHN-CAN-NCIC-SC16 (OTHER: UPJOHN)
  • CDR0000066788 (OTHER: PDQ unique registration number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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