Malignant PainPhase 2/3NCT02321397
To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain
A Phase 2/3 study testing Oxycodone and Naloxone in people with Malignant Pain and Non-malignant Pain, run by Mundipharma Research GmbH & Co KG at 1 site in Germany.
Trial summary
This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pain, Non-malignant Pain
- What is being tested?
- Oxycodone and Naloxone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Sep 2016
- Phase
- Phase 2/3
- 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 who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
- Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy
Who cannot join
- Females who are pregnant or lactating.
- Subjects with evidence or significant structural abnormalities of the gastrointestinal tract.
- Subjects with evidence of impaired liver/kidney function upon entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-blind, Double-dummy, Cross-over Multicenter Study to Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Taking Oxycodone Equivalents of 120 & 160 mg Per Day as Achieved With the Higher OXN PR Tablet Strengths (OXN60/30 mg PR, OXN80/40 mg PR) BID Compared to the Identical Daily Dose Taken as a Combination of Lower Tablet Strengths in Subjects With Non-malignant or Malignant Pain That Requires Around-the-clock Opioid Therapy.
This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.
Read the detailed description
Study OXN3508 is a multicenter double-blind, double-dummy, randomised, cross-over, 2-period, phase III study in male and female subjects with severe non-malignant or malignant pain that requires around-the-clock opioid therapy at a daily dose of 120/60 mg or 160/80 mg oxycodone/naloxone prolonged release (OXN PR).
- Conditions
- Malignant Pain, Non-malignant Pain
- Being tested
- Oxycodone, Naloxone
- Keywords
- oxycodone naloxone combination, severe chronic and non-malignant pain, Malignant and non-malignant pain that requires around-the clock opioid therapy
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
NaloxoneDrug
Prolonged Release Tablets
| Study group | Role | What they receive |
|---|---|---|
| OXN PR HST | Experimental | Prolonged release oxycodone/naloxone higher strength tablets Receives: Drug: Oxycodone |
| OXN PR LST | Active comparator | Prolonged release oxycodone/naloxone lower strength tablets Receives: Drug: Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
(mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)
Pain scores based on the mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale. To demonstrate equivalence between multiple lower strength OXN PR tablets and a single higher strength OXN PR tablet taken at the same overall total daily dose
Measured: 24 hours at one day in week 2, 3 5 and 6 from date of randomisation.
Equivalent bowel function as assessed by the Bowel Function Index (BFI).
Measured: Week 2, 3 5 and 6 from date of randomisation.
Secondary outcomes (5)
Pain scores of subjects average pain over the last 24 hours and rescue medication use.
Measured: Week 1,2,3,4,5 and 6 from date of randomisation
To assess bowel function (assess BFI and laxative use)
To assess BFI and laxative use
Measured: Week 1,2,3,4,5 and 6 from date of randomisation
To assess quality of life based on the EuroQol EQ-5D.
EuroQol EQ-5D is a standardized instrument for use as a measure of health outcome.
Measured: Visit 3 and visit 6 from date of randomisation
Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings.
Measured: Up to 35 weeks
Pain right now scores at intake of oxycodone/naloxone tablets.
Measured: Week 2,3,5 and 6 from date of randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 155 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
- NCT02321397
- Sponsor's protocol ID
- OXN3508
- Other IDs
- 2013-004888-31
- Status last verified
- Dec 2015
- First submitted
- 13 Oct 2014
- Last updated
- 4 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Double-dummy, Cross-over Multicenter Study to Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Taking Oxycodone Equivalents of 120 & 160 mg Per Day as Achieved With the Higher OXN PR Tablet Strengths (OXN60/30 mg PR, OXN80/40 mg PR) BID Compared to the Identical Daily Dose Taken as a Combination of Lower Tablet Strengths in Subjects With Non-malignant or Malignant Pain That Requires Around-the-clock Opioid Therapy.
- ClinicalTrials.gov ID
- NCT02321397
- Acronym / sponsor ID
- OXN3508
- Conditions
- Malignant Pain, Non-malignant Pain
- Keywords
- oxycodone naloxone combination, severe chronic and non-malignant pain, Malignant and non-malignant pain that requires around-the clock opioid therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Mundipharma Research GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Dec 2014 (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.
This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.
Detailed description
Study OXN3508 is a multicenter double-blind, double-dummy, randomised, cross-over, 2-period, phase III study in male and female subjects with severe non-malignant or malignant pain that requires around-the-clock opioid therapy at a daily dose of 120/60 mg or 160/80 mg oxycodone/naloxone prolonged release (OXN PR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OXN PR HST | Experimental | Drug: OxycodoneProlonged release oxycodone/naloxone higher strength tablets |
| OXN PR LST | Active comparator | Drug: NaloxoneProlonged release oxycodone/naloxone lower strength tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
- Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy
Key exclusion criteria (3 listed)
- Females who are pregnant or lactating.
- Subjects with evidence or significant structural abnormalities of the gastrointestinal tract.
- Subjects with evidence of impaired liver/kidney function upon entry into the study.
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 | Drug | OXN PR HST |
| NaloxoneProlonged Release Tablets | Drug | OXN PR LST |
Primary outcome
(mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)
Time frame: 24 hours at one day in week 2, 3 5 and 6 from date of randomisation.
Pain scores based on the mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale. To demonstrate equivalence between multiple lower strength OXN PR tablets and a single higher strength OXN PR tablet taken at the same overall total daily dose
Equivalent bowel function as assessed by the Bowel Function Index (BFI).
Time frame: Week 2, 3 5 and 6 from date of randomisation.
5 secondary outcomes
Pain scores of subjects average pain over the last 24 hours and rescue medication use.
Time frame: Week 1,2,3,4,5 and 6 from date of randomisation
To assess bowel function (assess BFI and laxative use)
Time frame: Week 1,2,3,4,5 and 6 from date of randomisation
To assess quality of life based on the EuroQol EQ-5D.
Time frame: Visit 3 and visit 6 from date of randomisation
Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings.
Time frame: Up to 35 weeks
Pain right now scores at intake of oxycodone/naloxone tablets.
Time frame: Week 2,3,5 and 6 from date of randomisation
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 4 Nov 2016.
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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 2/3 study testing Oxycodone and Naloxone in people with Malignant Pain and Non-malignant Pain, run by Mundipharma Research GmbH & Co KG at 1 site in Germany.
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 2 inclusion and 3 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 4 Nov 2016. 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 Germany. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
(mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.) (time frame: 24 hours at one day in week 2, 3 5 and 6 from date of randomisation.). The study lists 2 primary outcomes in all. 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 4 Nov 2016.