ConstipationPhase 3OXN3505NCT01014559
Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients
A Phase 3 study testing Oxycodone Naloxone and Oxycodone PR Tablets in people with Constipation and Pain, run by Mundipharma SAS at 1 site in France.
Trial summary
The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Pain
- What is being tested?
- Oxycodone Naloxone and Oxycodone PR Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Feb 2013
- 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 patient aged 18 years or older.
- With cancer pain or non-cancer pain such as chronic low back pain, osteoarthritis or other.
- Either currently receiving a WHO step II opioid and requiring the initiation of a WHO step III opioid (due to a lack of efficacy of the step II opioid) expected to last 28 days or more, or currently receiving a WHO step III opioid expected to last further 28 days or more.
- Having opioid-related constipation defined by either a KESS score ≥ 9 or the current use of laxatives (at least 3 times per week).
- Able, in the opinion of the Investigator, to comply with the study protocol.
- Women of childbearing potential must have a negative urine pregnancy test result at inclusion (test under supervision of the investigator) and use an effective birth control method. Women of non-childbearing potential must be postmenopausal or surgically sterile (hysterectomy and/or bilateral oophorectomy).
- Having received oral and written information about the study protocol and signed a written, informed consent to participate.
Who cannot join
- Pregnancy or breastfeeding.
- Known contraindication or hypersensitivity to oxycodone, naloxone, bisacodyl, any chemically close substance, and ingredients.
- Clinically significant impairment of cardiovascular, respiratory, liver or kidney function disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that in the opinion of the Investigator may present a risk upon exposure to the study medication.
- Known or suspected unstable brain or spinal cord metastases that may require changes in steroid treatment throughout the duration of the study.
- Increased intracranial pressure.
- Evidence of clinically significant gastrointestinal disease (e.g., paralytic ileus, peritoneal carcinosis), significant structural abnormalities of the gastrointestinal tract (e.g., scarring, obstruction etc) either related or not related to the underlying cancer or disease progression.
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- Rheumatoid arthritis, as co-medication may have an impact on the study results, especially if co-medication is not stable within the study.
- 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.
- Cyclic chemotherapy in the two weeks before inclusion or planned during the study that has shown in the past to influence bowel function. Patients having their first cycle of chemotherapy during the 2 weeks before the inclusion visit or during the study they should not be included in the study.
- Radiotherapy that, in the investigators opinion, would influence bowel function or pain during the study.
- Treatment with an opioid receptor antagonist in the month preceding inclusion.
- History of alcohol, opioid or other drug abuse.
- Current treatment with another psychoactive drug that, in the opinion of the Investigator, may present a risk when associated with an opioid.
- Any somatic or psychic condition that, in the opinion of the Investigator, may compromise the ability of the patient to understand and comply with the study protocol or to provide informed consent to participate.
- Patient who participated in a clinical research involving a new chemical entity or an experimental drug within 30 days of study entry. Concurrent enrolment in another clinical trial is not permitted unless the sole purpose of the other trial at the time of the OXN3505 inclusion visit is for long-term follow-up/survival data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Efficacy of OXN PR, Compared to Oxy PR, for Reduction of Intensity of Opioid-induced Constipation Symptoms in Pts Treated for Cancer or Non-cancer Pain: A Randomised, Double-blind, Controlled, Multicentre Study
The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain.
Read the detailed description
Eligible patients with documented cancer or non-cancer pain, either currently receiving a WHO step II opioid and requiring the initiation of a WHO step III opioid or currently receiving a WHO step III opioid, and having opioid-related constipation defined by either a KESS score ≥9 or the current use of laxatives (≥3 times per week), will be randomly assigned to receive either OXN PR or Oxy PR. Randomisation will be stratified on the cause of pain: cancer or non-cancer.
Any patient having completed the study and wishing to receive OXN PR afterwards may enter an optional open extension phase. During this phase, all patients will receive OXN PR and be managed as per the usual practice in the center until commercial OXN PR is available in France (with a limit of 1 year after Day 28). Adverse events will be assessed at each visit.
- Conditions
- Constipation, Pain
- Being tested
- Oxycodone Naloxone, Oxycodone PR Tablets
- Keywords
- Constipation, Oxycodone, Oxycodone hydrochloride, Naloxone hydrochloride, Naloxone
- Medical subject headings
- Constipation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone NaloxoneDrug
Oxycodone Naloxone PR Tablet taken twice daily
Oxycodone PR TabletsDrug
Oxycodone PR Tablets taken twice daily
| Study group | Role | What they receive |
|---|---|---|
| Prolonged release tablet | Active comparator | OxyCodone Naloxone controlled release tablet Receives: Drug: Oxycodone Naloxone |
| Tablet | Active comparator | Oxycodone PR Tablets Receives: Drug: Oxycodone PR Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of intensity of constipation symptoms, as assessed by the BFI from baseline to Day 28. The BFI is the mean value of 3 single items: Ease of defecation; Feeling of incomplete bowel evacuation; Personal judgement of constipation.
Measured: 28 days
Secondary outcomes (1)
Change of BFI from baseline (bl) to Days 7,14,21. Change of PAC-SYM score from bl to Days 7,14,21,28. Change of KESS score from bl to Days 7,14,21,28. Frequency of laxative medication use between Day 0 & Day 28. Change of pain as assessed by BPI-SF
Measured: Days 7, 14 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
- Study completionFeb 2013
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014559
- Sponsor's protocol ID
- OXN3505
- Other IDs
- 2009-012051-20, 2009
- Acronym
- OXN3505
- Status last verified
- Sep 2015
- First submitted
- 16 Nov 2009
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy of OXN PR, Compared to Oxy PR, for Reduction of Intensity of Opioid-induced Constipation Symptoms in Pts Treated for Cancer or Non-cancer Pain: A Randomised, Double-blind, Controlled, Multicentre Study
- ClinicalTrials.gov ID
- NCT01014559
- Acronym / sponsor ID
- OXN3505 / OXN3505
- Conditions
- Constipation, Pain
- Keywords
- Constipation, Oxycodone, Oxycodone hydrochloride, Naloxone hydrochloride, Naloxone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Mundipharma SASIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Nov 2009 (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 of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain.
Detailed description
Eligible patients with documented cancer or non-cancer pain, either currently receiving a WHO step II opioid and requiring the initiation of a WHO step III opioid or currently receiving a WHO step III opioid, and having opioid-related constipation defined by either a KESS score ≥9 or the current use of laxatives (≥3 times per week), will be randomly assigned to receive either OXN PR or Oxy PR. Randomisation will be stratified on the cause of pain: cancer or non-cancer.
Any patient having completed the study and wishing to receive OXN PR afterwards may enter an optional open extension phase. During this phase, all patients will receive OXN PR and be managed as per the usual practice in the center until commercial OXN PR is available in France (with a limit of 1 year after Day 28). Adverse events will be assessed at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged release tablet | Active comparator | Drug: Oxycodone NaloxoneOxyCodone Naloxone controlled release tablet |
| Tablet | Active comparator | Drug: Oxycodone PR TabletsOxycodone PR Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patient aged 18 years or older.
- With cancer pain or non-cancer pain such as chronic low back pain, osteoarthritis or other.
- Either currently receiving a WHO step II opioid and requiring the initiation of a WHO step III opioid (due to a lack of efficacy of the step II opioid) expected to last 28 days or more, or currently receiving a WHO step III opioid expected to last further 28 days or more.
- Having opioid-related constipation defined by either a KESS score ≥ 9 or the current use of laxatives (at least 3 times per week).
- Able, in the opinion of the Investigator, to comply with the study protocol.
Key exclusion criteria (15 listed)
- Pregnancy or breastfeeding.
- Known contraindication or hypersensitivity to oxycodone, naloxone, bisacodyl, any chemically close substance, and ingredients.
- Clinically significant impairment of cardiovascular, respiratory, liver or kidney function disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that in the opinion of the Investigator may present a risk upon exposure to the study medication.
- Known or suspected unstable brain or spinal cord metastases that may require changes in steroid treatment throughout the duration of the study.
- Increased intracranial pressure.
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 NaloxoneOxycodone Naloxone PR Tablet taken twice daily | Drug | Prolonged release tablet |
| Oxycodone PR TabletsOxycodone PR Tablets taken twice daily | Drug | Tablet |
Primary outcome
Change of intensity of constipation symptoms, as assessed by the BFI from baseline to Day 28. The BFI is the mean value of 3 single items: Ease of defecation; Feeling of incomplete bowel evacuation; Personal judgement of constipation.
Time frame: 28 days
1 secondary outcome
Change of BFI from baseline (bl) to Days 7,14,21. Change of PAC-SYM score from bl to Days 7,14,21,28. Change of KESS score from bl to Days 7,14,21,28. Frequency of laxative medication use between Day 0 & Day 28. Change of pain as assessed by BPI-SF
Time frame: Days 7, 14 and 21
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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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 Naloxone and Oxycodone PR Tablets in people with Constipation and Pain, run by Mundipharma SAS at 1 site in France.
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 7 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: stopped early, as of the sponsor's last update on 28 Sep 2015. 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 France. 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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
Change of intensity of constipation symptoms, as assessed by the BFI from baseline to Day 28. The BFI is the mean value of 3 single items: Ease of defecation; Feeling of incomplete bowel evacuation; Personal judgement of constipation. (time frame: 28 days). 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 28 Sep 2015.