PainPhase 3NCT01167127
Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain
A Phase 3 study testing Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release in people with Pain, run by Mundipharma Pharmaceuticals B.V. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Study to Observe OXN Treatment for Patients With Moderate to Severe Non-malignant Pain
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release
- Keywords
- Oxycodone/naloxone, pain relief, bowel function, moderate to severe non-malignant pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged releaseDrug
OXN Tablet, oral, BID, flexible dose design
| Study group | Role | What they receive |
|---|---|---|
| Tablet | No intervention | OXN tablet, oral BID, flexible dose design Receives: Drug: Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Pharmaceuticals B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167127
- Sponsor's protocol ID
- OXN3504
- Other IDs
- 2008-007013-71, 2008
- Status last verified
- Jul 2012
- First submitted
- 20 Jul 2010
- Last updated
- 12 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study to Observe OXN Treatment for Patients With Moderate to Severe Non-malignant Pain
- ClinicalTrials.gov ID
- NCT01167127
- Acronym / sponsor ID
- OXN3504
- Conditions
- Pain
- Keywords
- Oxycodone/naloxone, pain relief, bowel function, moderate to severe non-malignant pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Mundipharma Pharmaceuticals B.V.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tablet | No intervention | Drug: Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged releaseOXN tablet, oral BID, flexible dose design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged releaseOXN Tablet, oral, BID, flexible dose design | Drug | Tablet |
Primary outcome
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
1 secondary outcome
Bowel movement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release in people with Pain, run by Mundipharma Pharmaceuticals B.V. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.