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Trial registered on ANZCTR


Registration number
ACTRN12607000493448
Ethics application status
Approved
Date submitted
4/09/2007
Date registered
24/09/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study comparing oxycodone to oxycodone/naloxone in moderate to severe, chronic cancer pain.
Scientific title
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.
Secondary ID [1] 465 0
NCT00513656 ClinicalTrials.gov
Universal Trial Number (UTN)
Trial acronym
CONFORT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to severe chronic cancer pain.
Constipation. 2207 0
Condition category
Condition code
Cancer 2302 2302 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxycodone/Naloxone prolonged release,
5/2.5, 10/5, 20/10, 40/20 mg oxycodone/naloxone combination, 12 hourly for 4 weeks, taken orally
Intervention code [1] 2081 0
Treatment: Drugs
Comparator / control treatment
Oxycodone Prolonged Release
5, 10, 20, 40 mg oxycodone, 12 hourly for 4 weeks, taken orally
Control group
Active

Outcomes
Primary outcome [1] 3194 0
Efficacy variable:
Bowel Function Index (BFI) score.
Timepoint [1] 3194 0
Visit 1, Visit 2, Visit 6, Visit 7, Visit 8, Visit 9, Visit 12, Visit 13
Primary outcome [2] 3195 0
Amount of laxative medication use recorded at each assessment visit.
Timepoint [2] 3195 0
Visit 6, Visit 7, Visit 8, Visit 9
Primary outcome [3] 3196 0
Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991).
Timepoint [3] 3196 0
Visit 1, Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9, Visit 10, Visit 11, Visit 12, Visit 13
Primary outcome [4] 3197 0
Amount of analgesic rescue medication used.
Timepoint [4] 3197 0
Recorded Daily for 4 weeks
Secondary outcome [1] 5325 0
Number of bowel movements.
Timepoint [1] 5325 0
Visit 1, Visit 2, Visit 6, Visit 7, Visit 8, Visit 9, Visit 12, Visit 13
Secondary outcome [2] 5326 0
Modified Subjective Opiate Withdrawal Scale (SOWS).
Timepoint [2] 5326 0
Visit 1, Visit 2, Visit 3, Visit 4, Visit 5, Visit 6.
V10, V11
Secondary outcome [3] 5327 0
EuroQol EQ-5D
Timepoint [3] 5327 0
Visit 1, Visit 9,
Visit 12, Visit 13
Secondary outcome [4] 5328 0
EORTC QLQ-C30 (Quality of Life Questionnaire-Core 36).
Timepoint [4] 5328 0
Visit 1, Visit 9,
Visit 12, Visit 13
Secondary outcome [5] 5329 0
PAC-SYM, a validated questionnaire assessing the symptoms of constipation.
Timepoint [5] 5329 0
Visit 1, Visit 2, Visit 9,
Visit 12, Visit 13
Secondary outcome [6] 5330 0
PAC-SYM(b). This is an adaptation of the PAC-SYM (Frank et al. 1999), which includes the first 12 questions of the validated PAC-SYM and an additional measure of bothersomeness of the symptoms of constipation.
Timepoint [6] 5330 0
Visit 1, Visit 2, Visit 9,
Visit 12, Visit 13

Eligibility
Key inclusion criteria
1. Subjects 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 sterilisation, 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
a.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.
b.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.
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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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, peritnoneal 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 diarrhoea 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
cenral random allocation system using IVR system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random allocation schedule generated by a computer programme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
double-dummy
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 548 0
United Kingdom
State/province [1] 548 0
Country [2] 549 0
Czech Republic
State/province [2] 549 0
Country [3] 550 0
France
State/province [3] 550 0
Country [4] 551 0
Hungary
State/province [4] 551 0
Country [5] 552 0
Israel
State/province [5] 552 0
Country [6] 553 0
Germany
State/province [6] 553 0
Country [7] 554 0
Netherlands
State/province [7] 554 0
Country [8] 555 0
Poland
State/province [8] 555 0

Funding & Sponsors
Funding source category [1] 2590 0
Commercial sector/Industry
Name [1] 2590 0
Mundipharma Research GmbH & Co KG
Country [1] 2590 0
Germany
Primary sponsor type
Commercial sector/Industry
Name
Mundipharma Research GmbH & Co KG
Address
Höhenstrasse 10
65549 Limburg
Country
Germany
Secondary sponsor category [1] 2240 0
None
Name [1] 2240 0
Address [1] 2240 0
Country [1] 2240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4511 0
Bellbery Human Research Ethics Committee
Ethics committee address [1] 4511 0
Ethics committee country [1] 4511 0
Australia
Date submitted for ethics approval [1] 4511 0
Approval date [1] 4511 0
06/08/2007
Ethics approval number [1] 4511 0
Ethics committee name [2] 6203 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [2] 6203 0
Ethics committee country [2] 6203 0
Australia
Date submitted for ethics approval [2] 6203 0
Approval date [2] 6203 0
19/12/2007
Ethics approval number [2] 6203 0
New ethics HREC. Please modify.
Ethics committee name [3] 6204 0
Sydney South West
Ethics committee address [3] 6204 0
Ethics committee country [3] 6204 0
Australia
Date submitted for ethics approval [3] 6204 0
Approval date [3] 6204 0
17/12/2007
Ethics approval number [3] 6204 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27736 0
Address 27736 0
Country 27736 0
Phone 27736 0
Fax 27736 0
Email 27736 0
Contact person for public queries
Name 11111 0
Jill Kiteley & Catharina Buschmann
Address 11111 0
Höhenstrasse 10
65549 Limburg
Country 11111 0
Germany
Phone 11111 0
+49 6431 701 770
Fax 11111 0
Email 11111 0
info@contact-clinical-trials.com
Contact person for scientific queries
Name 2039 0
Jill Kiteley & Catharina Buschmann
Address 2039 0
Höhenstrasse 10
65549 Limburg
Country 2039 0
Germany
Phone 2039 0
+49 6431 701 770
Fax 2039 0
Email 2039 0
info@contact-clinical-trials.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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