Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain
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ClinicalTrials.gov Identifier: NCT01167127 |
Recruitment Status
:
Completed
First Posted
: July 22, 2010
Last Update Posted
: February 12, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Drug: Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release | Phase 3 |
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 |
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
|
- Pain ReliefThe Pain relief (NAS, 0-100) and the Bowel Function Index (BFI), 3 questions, both at week 1-4 of the core study
- Bowel movementBowel 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
- 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).
- Patients are willing to discontinue pre study laxative medication.
- 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.
- 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:
- Any history of hypersensitivity to oxycodone, naloxone, related products, and other ingredients.
- Patients that require a dose over 20 mg/day oxycodone at the start of the study.
- Active alcohol or drug abuse and/or history of opioid abuse.
- 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.
- 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.
- Patients receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine).
- Patients with uncontrolled seizures or convulsive disorder.
- Patients who have a confirmed diagnosis of ongoing irritable bowel syndrome.
- 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).
- Patients who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry.
- 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.
- Patients presently taking, or who have taken, naloxone <30 days prior to the start of the study.
- Patients suffering from diarrhoea and/or opioid withdrawal.
- 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.
- Patients with myxodema, hypothyroidism, Addisons disease, increase of intracranial pressure and/or epilepsy (see also exclusion criteria 7).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167127
Netherlands | |
Leeuwarden, Netherlands |
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 Key Record Dates |
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:
Oxycodone Naloxone Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |