Cancer, Pain, Constipation
Conditions
Keywords
Efficacy, chronic, cancer, pain, constipation, oxycodone, naloxone, Moderate to severe chronic cancer pain
Brief summary
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.
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.
Interventions
DRUGOxycodone
Sponsors
Mundipharma Research GmbH & Co KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit | 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 | 4 weeks and a 6 month open label |
Secondary
| Measure | Time frame |
|---|---|
| EuroQol EQ-5D | — |
| EORTC QLQ-C30 | — |
| Number of bowel movements | — |
| PAC-SYM(b) | — |
| PAC-SYM | — |
| Modified Subjective Opiate Withdrawal Scale (SOWS) | — |
Countries
United Kingdom
Outcome results
None listed