- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378937
Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain
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.
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
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)
|
Secondary Outcome Measures
Outcome Measure |
---|
Quality of sleep
|
Percentage of time in assessment periods 3 and 4 with a BS-11 pain score of ≤ 4
|
Mean BS-11 pain scores
|
Time to reach stable pain control
|
Mean escape medication use
|
Global assessment of pain relief with study drugs
|
Mean pain intensity, pain interference, and pain relief scores as measured by the Brief Pain Inventory
|
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
|
Collaborators and Investigators
Investigators
- Study Chair: Geoff Hanks, MD, University Hospitals Bristol and Weston NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Cancer Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Acetaminophen
- Morphine
- Oxycodone
- Codeine
- Dextropropoxyphene
- Levopropoxyphene
Other Study ID Numbers
- CRUK-ON/2003/1772
- CDR0000507650 (REGISTRY: PDQ (Physician Data Query))
- EU-20640
- EUDRACT-2004-004235-66
- NAPP-CRUK-ON/2003/1772
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.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on acetaminophen
-
Massachusetts General HospitalCompletedPain, Postoperative | Infertility, FemaleUnited States
-
Kaveh Aslani, MDCompletedAirway Obstruction | Tonsillitis | Difficulty SwallowingUnited States
-
Taipei Medical University WanFang HospitalUnknownCervical Radiculopathy | Radicular Pain | Acute Neck Pain | Cervicobrachial PainTaiwan
-
Medical University of South CarolinaCompletedPain, PostoperativeUnited States
-
MallinckrodtTerminatedAcute Pain, PostoperativeUnited States
-
Duke UniversityCompletedOsteoarthritis | Acetaminophen | Arthroplasty, Hip ReplacementUnited States
-
Jiangsu HengRui Medicine Co., Ltd.Active, not recruiting
-
Spectrum Health HospitalsTerminatedHip FractureUnited States
-
Babiash, Kimberly H., M.D.Unknown
-
Beth Israel Deaconess Medical CenterNational Center for Research Resources (NCRR); Harvard UniversityCompletedAcetaminophen Poisoning | Acetaminophen Metabolism | Drug Metabolism by ExcipientsUnited States