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

• Sponsor: Mundipharma Pharmaceuticals B.V.
• Information provided by (Responsible Party): Mundipharma Pharmaceuticals B.V.

Study Description

Brief Summary:

The main objective of the study is to observe the OXN treatment of patients with moderate to severe non-malignant pain in daily clinical practise with respect to pain relief and bowel function. 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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release	Phase 3

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 until discontinuation on request of the patient.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	113 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open Study to Observe OXN Treatment for Patients With Moderate to Severe Non-malignant Pain
Study Start Date :	June 2009
Actual Primary Completion Date :	April 2011
Actual Study Completion Date :	April 2011

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Tablet; OXN tablet, oral BID, flexible dose design	Drug: Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release; OXN Tablet, oral, BID, flexible dose design

Outcome Measures

Primary Outcome Measures :

1. Pain Relief
   The Pain relief (NAS, 0-100) and the Bowel Function Index (BFI), 3 questions, both at week 1-4 of the core study

Secondary Outcome Measures :

1. Bowel movement
   Bowel movement, 2 questions, and evaluation of laxative use, both at week 1-4 of the core study. Quality of Life (EQ-5D), 5 questions, at week 1 and 4 of the core study. 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). 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, at Week 2, 3, 4 of the core study (core study Week 1-4)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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 (opioids and co-analgesics like anti-depressants and anti-epileptics).
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).

Contacts and Locations

Locations

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Netherlands
Leeuwarden, Netherlands

Sponsors and Collaborators

Mundipharma Pharmaceuticals B.V.

More Information

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Responsible Party:	Mundipharma Pharmaceuticals B.V.
ClinicalTrials.gov Identifier:	NCT01167127 History of Changes
Other Study ID Numbers:	OXN3504; 2008-007013-71 ( EudraCT Number )
First Posted:	July 22, 2010
Last Update Posted:	February 12, 2013
Last Verified:	July 2012

Keywords provided by Mundipharma Pharmaceuticals B.V.:

Oxycodone/naloxone; pain relief; bowel function; moderate to severe non-malignant pain

Additional relevant MeSH terms:

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Oxycodone; Naloxone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants	Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Narcotic Antagonists