Subjects With Moderate to Severe, Chronic Nonmalignant PainPhase 3NCT01971632
A Randomised, Double Blind, Placebo and 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 Nonmalignant Pain
A Phase 3 study testing Oxycodone & naloxone combination, prolonged release in people with Subjects With Moderate to Severe, Chronic Nonmalignant Pain, run by Mundipharma Research GmbH & Co KG.
Trial summary
The primary objective was to demonstrate the superiority of OXN over placebo over time from the initial dose of study medication to multiple pain events (inadequate analgesia) during the double blind phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects With Moderate to Severe, Chronic Nonmalignant Pain
- What is being tested?
- Oxycodone & naloxone combination, prolonged release
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 463 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to May 2006
- 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
- Subjects had to meet all the following criteria to be included in this study:
- Males and females at least 18 years of age (Females less than one year post-menopausal had to have a negative serum or urine pregnancy test recorded within 72 hours prior to the first dose of study medication, be non-lactating, and willing to use adequate and reliable contraception throughout the study.).
- Documented history of moderate to severe chronic pain of low back that required around-the-clock opioid therapy.
- Nonmalignant low back pain adequately managed by an opioid analgesic for at least the past 2 weeks.
- Subjects who required continuation of daily opioid analgesic treatment and were likely to benefit from chronic opioid therapy for the duration of the study.
- Subjects willing and able to participate in all aspects of the study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
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- Amendment No. 1, dated 28-Sep-2004 prior to FPFV, changed the inclusion criteria to
- Bullet 3: Nonmalignant low back pain (for example osteoarthrosis / osteoarthritis of spine, deforming spondylosis, spondylolisthesis, disc herniation / sciatica, spinal stenosis) adequately managed by an opioid analgesic for at least the past 2 weeks.
- Bullet 4: Subjects who required continuation of daily opioid analgesic treatment and were likely to benefit from chronic opioid therapy (WHO step III opioid) for the duration of the study.
- (See Section 9.8.1) Any amendments to the protocol are included in Appendix 16.1.1.1. Exclusion Criteria -
- Subjects who met any of the following criteria were excluded from this study:
- Any history of hypersensitivity to oxycodone, naloxone, or related products.
- Subjects currently taking the equivalent of < 10 mg or > 40 mg/d oxycodone (Refer to Appendix 12.2 of the protocol: Drug Conversion Tables.).
- Subjects diagnosed with cancer, not including basal cell carcinoma.
- Active alcohol or drug abuse with severity sufficient to place the subjects at risk.
- Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, Electrocardiogram (ECG) results, and physical examination, that would have placed the subject at risk upon exposure to the study medication or that could confound the analysis and/or interpretation of the study results.
- 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) (outside of the reference range).
- Surgery completed less than 2 months prior to the start of the Screening Period, planned surgery during the 12-week Double-blind Phase, or any other pharmacological or non-pharmacological intervention that would have influenced pain during the study (not including chemotherapy) or precluded completion of the study.
- Subjects taking, or who had taken, naloxone or an experimental drug less than 30 days prior to the start of the Screening Period.
- Subjects with a history of 2 or greater low back surgeries. Amendment No. 1, dated 28-Sep-2004 prior to FPFV, changed the exclusion criterion bullet 4 to: Active alcohol or drug abuse.
- Amendment No. 2, dated 25-May-2005, changed the exclusion criterion bullet 9 to: Subjects with a history of less than 2 low back surgeries.
- (See Section 9.8.1) Any amendments to the protocol are included in Appendix 16.1.1.1. Subjects who did not meet the inclusion/exclusion criteria could be allowed to enter the study if, following discussion between the Investigator and CRO/Sponsor, written permission was obtained from the CRO/Sponsor. In such instances, written permission was filed at the investigational site and at the CRO/Sponsor.
Who cannot join
None listed.
About this study
The primary objective was to demonstrate the superiority of OXN over placebo over time from the initial dose of study medication to multiple pain events (inadequate analgesia) during the double blind phase.
- Being tested
- Oxycodone & naloxone combination, prolonged release, placebo oxycodone / naloxone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone & naloxone combination, prolonged releaseDrug
placebo oxycodone / naloxoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone/Naloxone | Active comparator | Not described Receives: Drug: Oxycodone & naloxone combination, prolonged release |
| Placebo oxycodone/naloxone | Placebo comparator | Not described Receives: Drug: placebo oxycodone / naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Analgesia
Primary Objective is To demonstrate the superiority of OXN over placebo on the time from the initial dose of study medication to multiple (ie, recurring) pain events (inadequate analgesia) during the Double-blind Phase.
Measured: up to 12 weeks
Secondary outcomes (2)
Quality of sleep assessment
Secondary To compare sleep quality during treatment with OXN compared with placebo and OXY compared with placebo as measured by the sleep interference item of the modified Brief Pain Inventory Short Form (modified BPI-SF)4.
Measured: up to 12 weeks
The amount of rescue medication taken
Secondary to compare the total amount of rescue medication used per day (24 hours) by subjects receiving OXN, OXY, and placebo.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startJan 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Moderate to Severe, Chronic Nonmalignant 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971632
- Sponsor's protocol ID
- OXN3401
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2013
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo and 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 Nonmalignant Pain
- ClinicalTrials.gov ID
- NCT01971632
- Acronym / sponsor ID
- OXN3401
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Mundipharma Research GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 29 Oct 2013 (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 primary objective was to demonstrate the superiority of OXN over placebo over time from the initial dose of study medication to multiple pain events (inadequate analgesia) during the double blind phase.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone/Naloxone | Active comparator | Drug: Oxycodone & naloxone combination, prolonged release |
| Placebo oxycodone/naloxone | Placebo comparator | Drug: placebo oxycodone / naloxone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Males and females at least 18 years of age (Females less than one year post-menopausal had to have a negative serum or urine pregnancy test recorded within 72 hours prior to the first dose of study medication, be non-lactating, and willing to use adequate and reliable contraception throughout the study.).
- Documented history of moderate to severe chronic pain of low back that required around-the-clock opioid therapy.
- Nonmalignant low back pain adequately managed by an opioid analgesic for at least the past 2 weeks.
- Subjects who required continuation of daily opioid analgesic treatment and were likely to benefit from chronic opioid therapy for the duration of the study.
- Subjects willing and able to participate in all aspects of the study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
Key exclusion criteria (0 listed)
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 & naloxone combination, prolonged release | Drug | Oxycodone/Naloxone |
| placebo oxycodone / naloxone | Drug | Placebo oxycodone/naloxone |
Primary outcome
Efficacy of Analgesia
Time frame: up to 12 weeks
Primary Objective is To demonstrate the superiority of OXN over placebo on the time from the initial dose of study medication to multiple (ie, recurring) pain events (inadequate analgesia) during the Double-blind Phase.
2 secondary outcomes
Quality of sleep assessment
Time frame: up to 12 weeks
The amount of rescue medication taken
Time frame: up to 12 weeks
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 23 Oct 2018.
- Results available on websiteLink provided by the sponsor.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxycodone & naloxone combination, prolonged release in people with Subjects With Moderate to Severe, Chronic Nonmalignant Pain, run by Mundipharma Research GmbH & Co KG.
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 22 inclusion and 0 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Efficacy of Analgesia (time frame: up to 12 weeks). 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 23 Oct 2018.