Interstitial CystitisPhase 2NCT01197261
OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
A Phase 2 study testing Oxycodone naloxone prolonged release tablets in people with Interstitial Cystitis and Painful Bladder Syndrome, run by Mundipharma Research GmbH & Co KG at 5 sites in 5 countries.
Trial summary
The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Interstitial Cystitis, Painful Bladder Syndrome, Pain
- What is being tested?
- Oxycodone naloxone prolonged release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Sep 2010to Jun 2013
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of severe pain due to Bladder Pain Syndrome (BPS) for at least 6 months
- Subject's treatment of pain due to BPS is insufficient
- Subjects must not have received opioid containing medication in the last 6 months
Who cannot join
- Females who are pregnant or lactating
- Subjects with any contraindication/history of hypersensitivity to oxycodone, naloxone, paracetamol, related products or other ingredients
- Subjects with any situation in which opioids are contraindicated like severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma or paralytic ileus
- Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results
- Abnormal aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatise levels (> 3 times the upper limit of normal), gamma glutamyl transpeptidase > 3 times the upper limit of normal
- Abnormal total bilirubin and/or creatinine level(s)
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: An Exploratory, Randomised, Double-blind, Placebo-controlled, Parallel Group, Pilot Study to Assess the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets (OXN PR) Compared to Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome.
The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.
Read the detailed description
The study consists of a screening period followed by randomisation of the patients in a 1:1 ratio to OXN PR treatment or placebo treatment in a double blind fashion. The double blind phase will last for 8 weeks.
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome, Pain
- Being tested
- Oxycodone naloxone prolonged release tablets, Placebo tablets
- Keywords
- Severe pain, Bladder Pain Syndrome, Interstitial Cystitis, Painful Bladder Syndrome, Severe pain due to Bladder Pain Syndrome/Interstitial Cystitis/Painful Bladder Syndrome
- Medical subject headings
- Cystitis, Interstitial, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone naloxone prolonged release tabletsDrug
2 tablets/ day
Placebo tabletsDrug
2 tablets/ day
| Study group | Role | What they receive |
|---|---|---|
| OXN PR | Active comparator | Oxycodone Naloxone tablets Receives: Drug: Oxycodone naloxone prolonged release tablets |
| PLA | Placebo comparator | Not described Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the patient's average pain during treatment with OXN PR compared with placebo
Measured: 8 weeks
Secondary outcomes (1)
Patient questionnaires
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT01197261
- Sponsor's protocol ID
- OXN2503
- Other IDs
- 2009-018118-21, 2009
- Status last verified
- Oct 2018
- First submitted
- 7 Sep 2010
- Last updated
- 23 Oct 2018
- Results posted
- 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
- An Exploratory, Randomised, Double-blind, Placebo-controlled, Parallel Group, Pilot Study to Assess the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets (OXN PR) Compared to Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome.
- ClinicalTrials.gov ID
- NCT01197261
- Acronym / sponsor ID
- OXN2503
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome, Pain
- Keywords
- Severe pain, Bladder Pain Syndrome, Interstitial Cystitis, Painful Bladder Syndrome, Severe pain due to Bladder Pain Syndrome/Interstitial Cystitis/Painful Bladder Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mundipharma Research GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Sep 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 study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.
Detailed description
The study consists of a screening period followed by randomisation of the patients in a 1:1 ratio to OXN PR treatment or placebo treatment in a double blind fashion. The double blind phase will last for 8 weeks.
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 |
|---|---|---|
| OXN PR | Active comparator | Drug: Oxycodone naloxone prolonged release tabletsOxycodone Naloxone tablets |
| PLA | Placebo comparator | Drug: Placebo tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of severe pain due to Bladder Pain Syndrome (BPS) for at least 6 months
- Subject's treatment of pain due to BPS is insufficient
- Subjects must not have received opioid containing medication in the last 6 months
Key exclusion criteria (6 listed)
- Females who are pregnant or lactating
- Subjects with any contraindication/history of hypersensitivity to oxycodone, naloxone, paracetamol, related products or other ingredients
- Subjects with any situation in which opioids are contraindicated like severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma or paralytic ileus
- Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results
- Abnormal aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatise levels (> 3 times the upper limit of normal), gamma glutamyl transpeptidase > 3 times the upper limit of normal
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 prolonged release tablets2 tablets/ day | Drug | OXN PR |
| Placebo tablets2 tablets/ day | Drug | PLA |
Primary outcome
To estimate the patient's average pain during treatment with OXN PR compared with placebo
Time frame: 8 weeks
1 secondary outcome
Patient questionnaires
Time frame: 8 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.
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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.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxycodone naloxone prolonged release tablets in people with Interstitial Cystitis and Painful Bladder Syndrome, run by Mundipharma Research GmbH & Co KG at 5 sites in 5 countries.
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 3 inclusion and 6 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.
Where is the study taking place?
The record lists 5 sites in Czechia, Germany, Hungary, Poland, United Kingdom. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To estimate the patient's average pain during treatment with OXN PR compared with placebo (time frame: 8 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.