PainNCT01812733
Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives
An observational study of Pain and Opioid Induced Constipation, run by Mundipharma AB at 1 site in Sweden.
Trial summary
The objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients with severe pain, and to evaluate the cost-effectiveness of treatment with Targiniq. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Opioid Induced Constipation
- How many people
- 37 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2013to Jun 2015
- Phase
- Observational
- 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
Study population: The patients have severe pain treated with opioids and will be enrolled at different clinics in Sweden
Who may be able to join
- Male or non-pregnant female ≥18 years of age
- Malignant or non-malignant opioid sensitive pain
- Must sign an informed consent form (ICF)
- Must have a stable daily dose of oxycodone prolonged release formulation titrated to analgesic effect (as to be assessed by clinical experts)
- Use of laxatives for concomitant opioid-induced constipation in an adequate dose and length of time and without sufficient effect
- BFI ≥30 and state a discomfort caused by the constipation at screening
- Ability to answer the patient questionnaires and have an estimated overall life expectancy of at least six (6) months
Who cannot join
- History of, or on-going, abuse of alcohol and/or drugs
- Inability to read and understand written instructions, ICF or questionnaires
- Constipation not related to opioid use
- Unsuitable patient for other reason(s) in the opinion of the investigator
- Inpatients, if admission and/or discharge is expected during study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of Quality of Life, Resource Use and Costs Associated With Treatment of Severe Pain - a Comparison of a Combination of Oxycodone and Naloxone (Targiniq) Versus Oxycodone and Laxatives
The objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients with severe pain, and to evaluate the cost-effectiveness of treatment with Targiniq.
- Conditions
- Pain, Opioid Induced Constipation
- Medical subject headings
- Pain, Opioid-Induced Constipation
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Two visits performed over 8 weeks
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 posted18 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812733
- Sponsor's protocol ID
- OXN9513
- Status last verified
- Aug 2015
- First submitted
- 14 Mar 2013
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Quality of Life, Resource Use and Costs Associated With Treatment of Severe Pain - a Comparison of a Combination of Oxycodone and Naloxone (Targiniq) Versus Oxycodone and Laxatives
- ClinicalTrials.gov ID
- NCT01812733
- Acronym / sponsor ID
- OXN9513
- Conditions
- Pain, Opioid Induced Constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mundipharma ABIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Mar 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 objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients with severe pain, and to evaluate the cost-effectiveness of treatment with Targiniq.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients have severe pain treated with opioids and will be enrolled at different clinics in Sweden
Key inclusion criteria (7 listed)
- Male or non-pregnant female ≥18 years of age
- Malignant or non-malignant opioid sensitive pain
- Must sign an informed consent form (ICF)
- Must have a stable daily dose of oxycodone prolonged release formulation titrated to analgesic effect (as to be assessed by clinical experts)
- Use of laxatives for concomitant opioid-induced constipation in an adequate dose and length of time and without sufficient effect
Key exclusion criteria (5 listed)
- History of, or on-going, abuse of alcohol and/or drugs
- Inability to read and understand written instructions, ICF or questionnaires
- Constipation not related to opioid use
- Unsuitable patient for other reason(s) in the opinion of the investigator
- Inpatients, if admission and/or discharge is expected during study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life
Time frame: 8 Weeks
Two visits performed over 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 7 Aug 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?
An observational study of Pain and Opioid Induced Constipation, run by Mundipharma AB at 1 site in Sweden.
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 5 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 7 Aug 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 Sweden. 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.
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?
Quality of Life (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 7 Aug 2015.