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Chronic Myeloproliferative DisordersPhase 3NCT00003687

Treatment for Chronic Pain in Patients With Advanced Cancer

A Phase 3 study testing dextromethorphan hydrobromide and morphine sulfate in people with Chronic Myeloproliferative Disorders and Leukemia, run by NCIC Clinical Trials Group at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RATIONALE: Different drug formulations and combinations of drugs may help patients with chronic pain live more comfortably. It is not yet known which regimen is most effective for chronic pain. Read more about this study

Who is it for?
Ages 16 to 120 years
What is being tested?
dextromethorphan hydrobromide and morphine sulfate
How many people
87 participants
Where
4 sitesCanada
Study dates
11 Jun 1998to 10 Feb 2009
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven advanced cancer with chronic pain
  • Cancer pain requiring strong opioids having an average pain score of less than 6/10 on the visual analog scale within last 24 hours
  • Pain managed by a stable maintenance dose of MS-Contin formulation of morphine for at least 2 days with no more than 2 breakthrough immediate release morphine doses per 24 hours
  • Pain that is expected to be controlled by a stable and adequate total daily dose of sustained release morphine for the first 7 days of the study

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • Not specified

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Not specified

Hepatic:

  • SGOT or SGPT no greater than 3 times upper limit of normal (ULN)
  • No liver disease

Renal:

  • Creatinine no greater than 2 times ULN
  • No kidney failure

Pulmonary:

  • No clinically significant respiratory depression
  • No severe obstructive airway disease

Other:

  • Fluent in English or French
  • No known hypersensitivity or allergy to study medications or components or other multiple drug allergies
  • Normal cognition defined by the Folstein Mini-Mental State Questionnaire (at least 24/30 correct)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 14 days since prior chemotherapy

Endocrine therapy:

  • Concurrent steroids allowed

Radiotherapy:

  • At least 14 days since prior analgesic radiotherapy

Surgery:

  • Not specified

Other:

  • At least 3 months since prior investigational agents
  • At least 1 month since prior clinical study
  • No concurrent analgesics other than morphine
  • No other concurrent medications containing dextromethorphan
  • Concurrent antidepressant medication allowed
  • Concurrent nonsteroidal antiinflammatory drugs allowed
  • At least 14 days since prior monoamine oxidase (MAO) inhibitors
  • No concurrent MAO inhibitors

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex SR for Chronic Cancer Pain Relief in Terminally Ill Patients

RATIONALE: Different drug formulations and combinations of drugs may help patients with chronic pain live more comfortably. It is not yet known which regimen is most effective for chronic pain.

PURPOSE: Randomized phase III trial to compare the effectiveness of different morphine formulations with or without dextromethorphan in treating chronic pain in patients who have advanced cancer.

Read the detailed description

OBJECTIVES:

  • Compare the analgesic efficacy of two formulations of morphine (Statex SR versus MS-Contin) in patients requiring morphine for the treatment of chronic cancer pain.
  • Compare the effect of these 2 formulations of morphine on the total analgesic consumption, sleep disturbances, sleep and nausea, responses of different types of pain, and toxic effects experienced in the two treatment groups.
  • Compare the effect of coadministration of morphine and dextromethorphan versus morphine and placebo on pain control in the respective patient groups (phase B).
  • Compare the effect of morphine and dextromethorphan or placebo on total analgesic consumption, sleep disturbances, sleep and nausea, responses of different types of pain, and toxic effects on the two treatment groups (phase B).

OUTLINE: This is a randomized, double-blind, parallel-group, multicenter study. Patients are stratified by stabilization dose (less than 120 mg/day vs greater than 120 mg/day of morphine) and institution in phase A, and neuropathic pain (yes vs no) in phase B.

  • Phase A: Patients are randomized to receive oral morphine in one of two formulations (MS Contin or Statex SR) every 12 hours for 7 days.
  • Phase B: Eligible patients from phase A who have taken no more than 2 breakthrough doses of analgesic per day in the previous 2 days are re-randomized to receive dose escalated oral dextromethorphan capsules or placebo every 4 hours, and oral morphine tablets every 12 hours for 14 days.
  • Phase C: All patients fulfilling entry criteria at the end of phase A or any time during phase B may receive compassionate use morphine tablets for up to 90 days.

Patients complete a pain diary twice each day during treatment.

Being tested
dextromethorphan hydrobromide, morphine sulfate
Keywords
stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, monoclonal gammopathy of undetermined significance, recurrent adult Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, isolated plasmacytoma of bone, extramedullary plasmacytoma, refractory multiple myeloma, Waldenstrom macroglobulinemia, stage III multiple myeloma, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, small intestine lymphoma, unspecified adult solid tumor, protocol specific
Medical subject headings
Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Pain, Precancerous Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dextromethorphan hydrobromideDrug

  • morphine sulfateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start11 Jun 1998
  3. Primary completion26 Sep 2001
  4. Study completion10 Feb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003687
Sponsor's protocol ID
SC17
Other IDs
CAN-NCIC-SC17, CDR0000066789
Status last verified
Apr 2020
First submitted
1 Nov 1999
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • MacDonald S, Dudgeon DJ, Bruera E, et al.: A phase III double-blind equivalence study of two different formulations of slow-release morphine followed by a randomization between dextromethorphan or placebo plus Statex SR for chronic cancer pain relief in terminally ill patients. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1521, 2002.

  • Dudgeon DJ, Bruera E, Gagnon B, Watanabe SM, Allan SJ, Warr DG, MacDonald SM, Savage C, Tu D, Pater JL. A phase III randomized, double-blind, placebo-controlled study evaluating dextromethorphan plus slow-release morphine for chronic cancer pain relief in terminally ill patients. J Pain Symptom Manage. 2007 Apr;33(4):365-71. doi: 10.1016/j.jpainsymman.2006.09.017.

    PubMed 17397698

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