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PainPhase 4NCT00378937

Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain

A Phase 4 study testing acetaminophen, codeine phosphate and dextropropoxyphene hydrochloride in people with Pain and Unspecified Adult Solid Tumor, Protocol Specific, run by University Hospitals Bristol and Weston NHS Foundation Trust.

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: Oxycodone helps lessen pain caused by cancer and may improve quality of life. It is not yet known whether oxycodone works better and is more cost effective than standard therapy in treating patients with cancer pain. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
acetaminophen, codeine phosphate and dextropropoxyphene hydrochloride
Type of treatment
Surgery or procedure
How many people
30 participants
Where
No sites listed yet
Study dates
Jan 2004to Feb 2006
Phase
Phase 4
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Requires regular step-2 analgesia for the management of cancer-related pain

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Must be able to take oral medication
  • Must be willing and able to complete a daily patient assessment booklet (PAB)
  • No history of the following conditions:
  • Depression
  • Personality disorders that may lead to self-harm
  • Admission to the hospital for psychiatric reasons
  • Any other psychological disorder that, in the opinion of the investigator, would preclude study treatment
  • Not at risk of additional CNS depressant effects due to study drugs
  • No known history of alcohol or drug abuse or, in the opinion of the investigator, tendency towards drug abuse or addiction
  • No current abuse of alcohol or drugs
  • No known sensitivity to oxycodone hydrochloride or other opioids
  • No history of a specific or allergic reaction to study drugs
  • No contraindications as a result of adverse drug reaction or drug interactions of oxycodone or other opioid drugs
  • No other condition that, in the opinion of the investigator, would make the patient unsuitable for study participation

PRIOR CONCURRENT THERAPY:

  • More than 30 days since prior and no concurrent chemotherapy or radiotherapy
  • At least 2 weeks since prior regular (i.e., 4 times per day) step-2 analgesics
  • More than 3 months since prior regular use of opioids, defined as having a regular prescription of an opioid medication
  • Not planning to undergo cancer-related surgery
  • No other concurrent opioid-based medication other than oxycodone hydrochloride capsules as escape medication (arm II)
  • No concurrent participation in another clinical trial involving a new chemical entity

About this study

Official title: An Open, Randomized, Parallel Group Study in Patients With Cancer Pain, To Compare a Two-Step Analgesic Ladder (Non-Opioid to Oxycodone) With Conventional Management Using A Three-Step Approach

RATIONALE: Oxycodone helps lessen pain caused by cancer and may improve quality of life. It is not yet known whether oxycodone works better and is more cost effective than standard therapy in treating patients with cancer pain.

PURPOSE: This randomized phase IV trial is studying oxycodone to see how well it works compared with standard pain therapy in treating patients with cancer pain and if it is more cost effective than standard pain therapy.

Read the detailed description

OBJECTIVES:

Primary

  • Compare overall pain management in patients with cancer-related pain treated with oxycodone hydrochloride vs standard three-step analgesic therapy.
  • Compare the health economics of these regimens in these patients.

Secondary

  • Explore the factors that inform patients' decisions about commencing opioid analgesia.

OUTLINE: This is an open-label, multicenter, randomized, parallel group, pilot study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive an analgesic regimen, according to their level of pain, for up to 18 weeks.
  • Step 1: Patients in mild pain receive oral acetaminophen 4 times daily.
  • Step 2: Patients in mild-to-moderate pain receive oral codeine or oral dextropropoxyphene hydrochloride 4 times daily and oral acetaminophen 4 times daily.
  • Step 3: Patients in moderate-to-severe pain receive oral morphine or oral oxycodone hydrochloride 6 times daily (every 4 hours) with or without a non-opioid analgesic.

Patients may also receive an adjuvant drug (i.e., for side effects or for primary indication other than pain management that is analgesic in selected circumstances).

  • Arm II: Patients receive oral oxycodone hydrochloride twice daily for up to 18 weeks. Patients may receive a different opioid analgesic or analgesia or adjuvant medication as in arm I, if needed.

Patients in both arms may also receive additional medication for breakthrough pain.

Patients complete a patient-assessment booklet (PAB) daily which includes a Box-Scale (BS)-11 rating for average pain; questions regarding contact (e.g., telephone or visit) with healthcare professionals on that day; and information regarding the number of times escape medication is used.

Quality of life and levels of cancer pain are assessed using the short form of the Brief Pain Inventory (BPI).

After completion of study treatment, patients are followed at 4 weeks.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Being tested
acetaminophen, codeine phosphate, dextropropoxyphene hydrochloride, morphine sulfate, oxycodone hydrochloride
Keywords
unspecified adult solid tumor, protocol specific, pain
Medical subject headings
Pain

What participants receive

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

  • acetaminophenDrug

  • codeine phosphateDrug

  • dextropropoxyphene hydrochlorideDrug

  • morphine sulfateDrug

  • oxycodone hydrochlorideDrug

  • management of therapy complicationsProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of time in assessment periods 1 and 2 (i.e., first 4 weeks) with a Box-Scale (BS)-11 pain score of ≤ 4 (i.e., mild pain)

Secondary outcomes (8)

  1. Percentage of time in assessment periods 3 and 4 with a BS-11 pain score of ≤ 4

  2. Mean BS-11 pain scores

  3. Time to reach stable pain control

  4. Mean escape medication use

  5. Quality of sleep

  6. Global assessment of pain relief with study drugs

  7. Mean pain intensity, pain interference, and pain relief scores as measured by the Brief Pain Inventory

  8. Overall number of phone calls, home visits by a nurse, home visits by a doctor, and unscheduled visits to a healthcare provider, related to pain control or analgesic medication during study treatment

Timeline

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

  1. First posted21 Sep 2006 (estimated)
  2. Study startJan 2004
  3. Study completionFeb 2006

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 4
Primary purpose
Supportive care
Allocation
Randomised
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00378937
Sponsor's protocol ID
CRUK-ON/2003/1772
Other IDs
CDR0000507650, EU-20640, EUDRACT-2004-004235-66, NAPP-CRUK-ON/2003/1772
Status last verified
Jul 2007
First submitted
20 Sep 2006
Last updated
2 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing acetaminophen, codeine phosphate and dextropropoxyphene hydrochloride in people with Pain and Unspecified Adult Solid Tumor, Protocol Specific, run by University Hospitals Bristol and Weston NHS Foundation Trust.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time in assessment periods 1 and 2 (i.e., first 4 weeks) with a Box-Scale (BS)-11 pain score of ≤ 4 (i.e., mild pain). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00378937.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.

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