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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

Phase 4
18 Years
Open (Enrolling)
Pain, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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



- 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.


- 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

- 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

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.

Inclusion Criteria


- Diagnosis of cancer

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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

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)

Principal Investigator

Geoff Hanks, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospitals Bristol NHS Trust


United States: Federal Government

Study ID:




Start Date:

January 2004

Completion Date:

Related Keywords:

  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • pain