A Study Comparing Oxycodone to Oxycodone/Naloxone in Moderate to Severe, Chronic Cancer Pain

October 19, 2018 updated by: Mundipharma Research GmbH & Co KG

A Randomised, Double-blind, Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Cancer Pain

The purpose of this study is to test the oxycodone/naloxone combination compared to oxycodone alone in patient's specific type of "chronic cancer pain".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomised, double-blind, active-controlled, double-dummy, parallel group study using oxycodone/naloxone and oxycodone to treat moderate to severe, chronic cancer pain. Subjects with documented history of cancer pain that requires around-the-clock opioid therapy will be included. Subjects must have a medical history of constipation that was induced by, or worsened by their opioid therapy.

After subjects have qualified for the study they will be randomised and to enter the double-blind treatment phase of the study.

Subjects will be randomised to receive either oxycodone/naloxone or oxycodone. Subjects will receive the double-blind medication for a period of 4 weeks.

Subjects who complete the double-blind phase or who discontinue due to constipation and still comply with all relevant screening inclusion and exclusion criteria will have the option to enter the 24 week extension phase. Subjects will receive open-label oxycodone/naloxone for up to 24 weeks.

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Phase 2

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects at least 18 years or older with a diagnosis of cancer.
  2. Females less than one year post-menopausal must have a negative urine pregnancy test recorded at the screening visit, be non-lactating, and willing to use adequate and highly effective method of contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (hormonal), sexual abstinence or vasectomised partner.

  3. Subjects who are receiving WHO step II or Step III analgesic medication who have constipation induced, or worsened by their opioid medication, as shown by

    1. the subject's medical need of regular intake of laxatives to have at least 3 bowel evacuations per week, or having less than 3 bowel evacuations when not taking a laxative, respectively.
    2. the subject's self-assessment that their constipation was induced or worsened by their current pre-study opioid medication.
  4. Documented history of moderate to severe, chronic cancer pain that requires around-the-clock opioid therapy (starting dose at the beginning of the double-blind phase of oxycodone PR between 20 - 80 mg/day) and are likely to benefit from WHO step III opioid therapy for the duration of the study. Subjects must be willing to discontinue their current opioid analgesic routine.
  5. Subjects are willing to discontinue pre-study laxative medication and take study specific laxative medication.
  6. Subjects taking daily fibre supplementation or bulking agents are eligible if they can be maintained on a stable dose and regimen throughout the study, and in the investigators opinion are willing and able to maintain adequate hydration.
  7. Subjects willing and able (e.g. mental and physical condition) to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
  8. Subjects already taking non-opioid analgesics and all other concomitant medications (including those for the treatment of depression) are eligible to take part in the study. However, all concomitant medications that are considered necessary for the subject's welfare should be continued at a stable dose throughout the double-blind phase of the study and under the supervision of the investigator. Regarding cyclic chemotherapy please see exclusion criteria list.

Exclusion Criteria:

  1. Subjects that require a dose >80 mg/day oxycodone PR at the start of the double-blind phase.
  2. Any history of hypersensitivity to oxycodone, naloxone, bisacodyl, related products, and other ingredients.
  3. Subjects with any situation in which opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus.
  4. Evidence of clinically significant cardiovascular, renal, hepatic or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.
  5. Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (>3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (greater than 1.5 times the upper limit of normal).
  6. Subjects with known or suspected unstable brain metastases or spinal cord compression that may require changes in steroid treatment throughout the duration of the study.
  7. Subjects with uncontrolled seizures.
  8. Subjects with increased intracranial pressure.
  9. In the investigator's opinion, subjects who are receiving hypnotics or other central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication.
  10. Subjects with myxodema, not adequately treated hypothyroidism or Addisons disease.
  11. Active alcohol or drug abuse and/or history of opioid abuse.
  12. Subjects receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine).
  13. Subjects with evidence of clinically significant gastrointestinal disease (e.g. paralytic ileus, peritoneal carcinosis), significant structural abnormalities of the gastrointestinal tract (e.g. scarring, obstruction etc) either related or not related to the underlying cancer or disease progression.
  14. Subjects who have a confirmed diagnosis of ongoing irritable bowel syndrome.
  15. Subjects suffering from diarrhea and/or opioid withdrawal.
  16. Surgery completed prior to the start of the Screening Period, or planned surgery during the study that would influence pain or bowel function during the study or preclude completion of the study.
  17. Cyclic chemotherapy in the two weeks before the screening visit or planned during the core study that has shown in the past to influence bowel function. If subjects are having their first cycle of chemotherapy during the 2 weeks before the screening visit or during the double-blind phase of the study they should be excluded from the study.
  18. Radiotherapy that, in the investigators opinion, would influence bowel function or pain during the double-blind phase of the study.
  19. Subjects presently taking, or who have taken, naloxone 30 days prior to the start of the Screening Period.
  20. Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxycodone Hydrochloride Tablets
Drug: Oxycodone
Experimental: Oxycodone Naloxone Tablets
Drug: Oxycodone/Naloxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit
Time Frame: 4 weeks and a 6 month open label
4 weeks and a 6 month open label
Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used
Time Frame: 4 weeks and a 6 month open label
4 weeks and a 6 month open label

Secondary Outcome Measures

Outcome Measure
Number of bowel movements
Modified Subjective Opiate Withdrawal Scale (SOWS)
EuroQol EQ-5D
EORTC QLQ-C30
PAC-SYM
PAC-SYM(b)

Collaborators and Investigators

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

Sponsor

Mundipharma Research GmbH & Co KG

Investigators

  • Principal Investigator: Sam Ahmedzai, University of Sheffield

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

Helpful Links

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

September 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

July 27, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimate)

August 9, 2007

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXN2001
  • 2007-001313-42

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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