ConstipationPhase 2/3HMX3501NCT00992576
Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
A Phase 2/3 study testing Active Hydromorphone PR + Active Naloxone PR in people with Constipation, run by Mundipharma Research GmbH & Co KG at 14 sites in 14 countries.
Trial summary
The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Active Hydromorphone PR + Active Naloxone PR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 14 sitesin 14 countries
- Study dates
- Jan 2010to Jan 2012
- 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
- Male or female subjects at least 18 years with a history of non-cancer or cancer pain that requires around-the-clock opioid therapy (8, 24 or 48 mg hydromorphone PR per day for the duration of the study).
- Subjects with constipation caused or aggravated by opioids
- Subjects must be willing to discontinue their current opioid analgesic routine, and .
- current laxative regimen
Who cannot join
- Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis.
- Subjects presently taking, or who have taken, naloxone <=30 days prior to the start of the Screening Period.
- Subjects suffering from diarrhoea.
- Abnormal liver or kidney function.
Trial locations and contacts
14 sites in 14 countries.
14 sites in 14 countries
Australia1 site
Hunter New England Area Health Service
Newcastle, New South Wales, 2300
About this study
Official title: A Confirmatory, Placebo-controlled, Randomised, Double-blind, Single-dummy, Parallel Group, Ratio-finding Study in Constipated Pain Patients to Establish an Optimal Hydromorphone - Naloxone Ratio With an Improved Bowel Function and a Comparable Analgesic Efficacy Compared to Hydromorphone Alone
The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.
Read the detailed description
Subjects suffering from cancer or non-cancer pain suffering from constipation cased or aggravated by opioids will be randomised to one of four ratios of hydromorphone PR plus naloxone PR or Hydromorphone PR plus placebo to investigate whether a hydromorphone/naloxone combination will lead to comparable analgesia, with a decrease in constipation, and to investigate the optimal dose ratio of hydromorphone and naloxone.
- Conditions
- Constipation
- Being tested
- Active Hydromorphone PR + Active Naloxone PR, Active Hydromorphone PR + Placebo Naloxone PR
- Keywords
- Confirmatory, Constipation, Pain, Hydromorphone, 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.
Active Hydromorphone PR + Active Naloxone PRDrug
Optimal pain relief and improved bowel function in constipated pain patients
Active Hydromorphone PR + Placebo Naloxone PRDrug
Optimal pain relief and improved bowel function in constipated pain patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Function Measure Average pain scores
Secondary outcomes (1)
Bowel Function Measures Rescue medication use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionNov 2011
- Study completionJan 2012
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992576
- Sponsor's protocol ID
- 2008-005312-18
- Other IDs
- 2008
- Acronym
- HMX3501
- Status last verified
- Feb 2012
- First submitted
- 6 Oct 2009
- Last updated
- 15 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory, Placebo-controlled, Randomised, Double-blind, Single-dummy, Parallel Group, Ratio-finding Study in Constipated Pain Patients to Establish an Optimal Hydromorphone - Naloxone Ratio With an Improved Bowel Function and a Comparable Analgesic Efficacy Compared to Hydromorphone Alone
- ClinicalTrials.gov ID
- NCT00992576
- Acronym / sponsor ID
- HMX3501 / 2008-005312-18
- Conditions
- Constipation
- Keywords
- Confirmatory, Constipation, Pain, Hydromorphone, Naloxone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mundipharma Research GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Oct 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 purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.
Detailed description
Subjects suffering from cancer or non-cancer pain suffering from constipation cased or aggravated by opioids will be randomised to one of four ratios of hydromorphone PR plus naloxone PR or Hydromorphone PR plus placebo to investigate whether a hydromorphone/naloxone combination will lead to comparable analgesia, with a decrease in constipation, and to investigate the optimal dose ratio of hydromorphone and naloxone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects at least 18 years with a history of non-cancer or cancer pain that requires around-the-clock opioid therapy (8, 24 or 48 mg hydromorphone PR per day for the duration of the study).
- Subjects with constipation caused or aggravated by opioids
- Subjects must be willing to discontinue their current opioid analgesic routine, and .
- current laxative regimen
Key exclusion criteria (4 listed)
- Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis.
- Subjects presently taking, or who have taken, naloxone <=30 days prior to the start of the Screening Period.
- Subjects suffering from diarrhoea.
- Abnormal liver or kidney function.
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 |
|---|---|---|
| Active Hydromorphone PR + Active Naloxone PROptimal pain relief and improved bowel function in constipated pain patients | Drug | – |
| Active Hydromorphone PR + Placebo Naloxone PROptimal pain relief and improved bowel function in constipated pain patients | Drug | – |
Primary outcome
Bowel Function Measure Average pain scores
1 secondary outcome
Bowel Function Measures Rescue medication use
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 15 Feb 2012.
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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.
14 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Active Hydromorphone PR + Active Naloxone PR in people with Constipation, run by Mundipharma Research GmbH & Co KG at 14 sites in 14 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 4 inclusion and 4 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 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia, Austria, Belgium, Czechia, Denmark and 9 more countries. 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?
Bowel Function Measure Average pain scores. 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 15 Feb 2012.