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Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain

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ClinicalTrials.gov Identifier: NCT01167699
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Mundipharma Pharmaceuticals B.V.

Tracking Information
First Submitted Date  ICMJE July 20, 2010
First Posted Date  ICMJE July 22, 2010
Last Update Posted Date February 12, 2013
Study Start Date  ICMJE June 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
Patient preference of OXN compared to previous analgesics with respect to QOL
The patient preference of OXN treatment compared to previous WHO step I or II analgesics with respect to quality of life, measured at 5 categories, as Week 2, 3, 4 of the core study (core study Week 1-4)
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
OXN
The patient preference of OXN treatment compared to previous WHO step I or II analgesics with respect to quality of life, measured at 5 categories, as Week 2, 3, 4 of the core study (core study Week 1-4)
Change History Complete list of historical versions of study NCT01167699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
BFI, Bowel movement, Pain relief (NAS), QOL (EQ-5D)
The patient preference of OXN treatment compared to previous WHO step I or II analgesics with respect to overall treatment, measured at 5 categories, at Week 2, 3, 4 of the core study (core study Week 1-4). Bowel Function Index (BFI), 3 questions, at week 1-4 of the core study. Bowel movement, 2 questions, at week 1-4 of the core study. Pain relief (NAS, 0-100), at week 1-4 of the core study. Quality of Life (EQ-5D), 5 questions, at week 1 and 4 of the core study.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
OXN
The patient preference of OXN treatment compared to previous WHO step I or II analgesics with respect to overall treatment, measured at 5 categories, at Week 2, 3, 4 of the core study (core study Week 1-4). Bowel Function Index (BFI), 3 questions, at week 1-4 of the core study. Bowel movement, 2 questions, at week 1-4 of the core study. Pain relief (NAS, 0-100), at week 1-4 of the core study. Quality of Life (EQ-5D), 5 questions, at week 1 and 4 of the core study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain
Official Title  ICMJE An Open Study With OXN to Evaluate the Patient Preference for Pain Treatment With Respect to Quality of Life After WHO Stap I or Step II Analgesics for Patients With Moderate to Severe Non-malignant Pain
Brief Summary The main objective of the study is to evaluate the patient preference for pain treatment with respect to quality of life in patients with moderate to severe non malignant pain. Patients who have insufficient pain relief and/or unacceptable side effects with the previous analgesic treatment WHO step 1 or 2 and require around-the-clock opioid therapy can be included in the study. The WHO step I or II analgesics will be compared with the new study medication OXN (oxycodone/naloxone).
Detailed Description Patients will receive OXN for 3 weeks in the first phase (core phase) and in the second phase (extension phase) they will receive OXN as is daily clinical practice until reimbursement of OXN in the Netherlands or Belgium or until discontinuation on request of the patient.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE Drug: Oxycodone and naloxone
Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2013)
174
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2010)
180
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients at least 18 years or older with moderate to severe non-malignant pain who are willing to provide written informed consent.
  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 reliable 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 (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner.
  3. Patients with documented history of moderate to severe, non-malignant pain treated with WHO step I or II analgesics with insufficient pain relief and/or unacceptable side effects that requires around-the-clock opioid therapy (starting dose of oxycodone over 20 mg/day) and are likely to benefit from WHO step III opioid therapy for the duration of the study. Patients must be willing to discontinue their current analgesics, like opioids. Co-analgesics, such as anti-depressants and anti-epileptics, can be continued provided that the co-analgesics are used on a stable dose before and during the study.
  4. Patients are willing to discontinue pre study laxative medication.
  5. Patients 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.
  6. Patients willing and able 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.

Exclusion Criteria:

  1. Any history of hypersensitivity to oxycodone, naloxone, related products, and other ingredients.
  2. Patients that require a dose over 20 mg/day oxycodone at the start of the study.
  3. Active alcohol or drug abuse and/or history of opioid abuse.
  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 patient at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.
  5. In the investigator's opinion, patients who are receiving hypnotics or other central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication.
  6. Patients receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine).
  7. Patients with uncontrolled seizures or convulsive disorder.
  8. Patients who have a confirmed diagnosis of ongoing irritable bowel syndrome.
  9. Patients 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).
  10. Patients who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry.
  11. Surgery completed prior to the start of the study, or planned surgery during the study that would influence pain or bowel function during the study or preclude completion of the study.
  12. Patients presently taking, or who have taken, naloxone <30 days prior to the start of the study.
  13. Patients suffering from diarrhoea and/or opioid withdrawal.
  14. Patients with any situation in which opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia, severe obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus.
  15. Patients with myxodema, hypothyroidism, Addisons disease, increase of intracranial pressure and/or epilepsy (see also exclusion criteria 7).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01167699
Other Study ID Numbers  ICMJE OXN3501
2008-001026-14 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mundipharma Pharmaceuticals B.V.
Study Sponsor  ICMJE Mundipharma Pharmaceuticals B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mundipharma Pharmaceuticals B.V.
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP