Severe PainNCT01983137
A Non-interventional, Observational Study for Targinact® Treatment in Patients With Severe Pain.
An observational study of Severe Pain, run by Mundipharma CVA at 1 site in Belgium.
Trial summary
This non-interventional, observational study evaluates the efficacy of Targinact with regard to pain relief in daily clinical practice in Belgium compared to the previous analgesic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Pain
- What is being tested?
- Targinact® (oxycodone/naloxone)
- How many people
- 1,338 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2011to Dec 2012
- 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: GPs and specialists
Who may be able to join
- Patients who are to be included in the study, are those who meet all of the following criteria based on the SPC.
- Male or female patients at least 18 years, or older, with severe pain.
- Patients with documented history of severe pain treated with WHO step 1, step 2 and/or 3 analgesics with insufficient pain relief and/or unacceptable side effects that require around-the-clock opioid therapy and are likely to benefit from WHO step 3 opioid therapy for the duration of the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy, With Regard to Pain Relief, of Targinact® Treatment for Patients With Severe Pain Compared to Previous Analgesic Treatment; a Non-interventional Study.
This non-interventional, observational study evaluates the efficacy of Targinact with regard to pain relief in daily clinical practice in Belgium compared to the previous analgesic treatment.
Read the detailed description
Patients are treated with Targinact® according to daily clinical practice and are monitored during 3 study visits. Parameters assessed are efficacy regarding pain relief, efficacy regarding bowel function, pain relief, use of analgesic rescue medication, bowel function, use of laxatives, safety of Targinact treatment, use of concomitant medication, patient satisfaction and quality of life.
- Conditions
- Severe Pain
- Being tested
- Targinact® (oxycodone/naloxone)
- Keywords
- Chronic pain, Severe pain, oxycodon, naloxon, opioid-induced constipation, opioid, quality of life, laxative, analgesic rescue medication
- Medical subject headings
- Pain, Chronic Pain, Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targinact® (oxycodone/naloxone)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain
Efficacy will be evaluated by the physician (7 categories). For the analysis the ordinal scale will be reduced to a binary scale: responder or non-responder. A responder is defined as a patient responding ''slightly better'', ''better'' or ''much better'' at any time during the Targinact®therapy. A non-responder is defined as a patient responding "same", "slightly worse", "worse", "much worse".
Measured: Up to 140 days
Secondary outcomes (7)
Pain NAS score (0-10) will be measured at each visit
The relative changes from baseline at each visit will be used to compare the NAS pain scores during the Targinact® therapy.
Measured: Up to 140 days
Bowel Function Index (BFI) will be recorded at each visit
The Bowel Function Index is the mean value of the 3 single items included in the BFI:1/ Difficulty of bowel movement (0 to 100; 0 = easy/no difficulty, 100 = severe difficulty); 2/ Feeling of incomplete bowel evacuation (0 to 100; 0 = not at all, 100 = very strong); 3/ Judgement of constipation (0 to 100; 0 = not at all, 100 = very strong).
Measured: Up to 140 days
The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF
If laxative is used, the physician will document if it's used 1/ continuously, 2/ intermittently or 3/ rarely.
Measured: Up to 140 days
The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded
Measured: Up to 140 days
Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories)
For the analysis the ordinal scale will be reduced to a binary scale: responder or non-responder. A responder is defined as a patient responding ''slightly better'', ''better'' or ''much better'' at any time during the Targinact® therapy. A non-responder is defined as a patient responding "same", "slightly worse", "worse", "much worse".
Measured: Up to 140 days
The patient satisfaction will be evaluated by patient in 7 categories
much worse, worse, slightly worse, same, slightly better, better, much better.
Measured: Up to 140 days
The patient's quality of life will be evaluated via the EQ-5D questionnaire
Measured: Up to 140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- 1,338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma CVA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983137
- Sponsor's protocol ID
- OXN9510
- Status last verified
- Nov 2013
- First submitted
- 17 Apr 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, With Regard to Pain Relief, of Targinact® Treatment for Patients With Severe Pain Compared to Previous Analgesic Treatment; a Non-interventional Study.
- ClinicalTrials.gov ID
- NCT01983137
- Acronym / sponsor ID
- OXN9510
- Conditions
- Severe Pain
- Keywords
- Chronic pain, Severe pain, oxycodon, naloxon, opioid-induced constipation, opioid, quality of life, laxative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,338 participants (actual)
- Lead sponsor
- Mundipharma CVAUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Nov 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.
This non-interventional, observational study evaluates the efficacy of Targinact with regard to pain relief in daily clinical practice in Belgium compared to the previous analgesic treatment.
Detailed description
Patients are treated with Targinact® according to daily clinical practice and are monitored during 3 study visits. Parameters assessed are efficacy regarding pain relief, efficacy regarding bowel function, pain relief, use of analgesic rescue medication, bowel function, use of laxatives, safety of Targinact treatment, use of concomitant medication, patient satisfaction and quality of life.
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
- GPs and specialists
Key inclusion criteria (3 listed)
- Patients who are to be included in the study, are those who meet all of the following criteria based on the SPC.
- Male or female patients at least 18 years, or older, with severe pain.
- Patients with documented history of severe pain treated with WHO step 1, step 2 and/or 3 analgesics with insufficient pain relief and/or unacceptable side effects that require around-the-clock opioid therapy and are likely to benefit from WHO step 3 opioid therapy for the duration of the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Targinact® (oxycodone/naloxone) | Drug | – |
Primary outcome
To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain
Time frame: Up to 140 days
Efficacy will be evaluated by the physician (7 categories). For the analysis the ordinal scale will be reduced to a binary scale: responder or non-responder. A responder is defined as a patient responding ''slightly better'', ''better'' or ''much better'' at any time during the Targinact®therapy. A non-responder is defined as a patient responding "same", "slightly worse", "worse", "much worse".
7 secondary outcomes
Pain NAS score (0-10) will be measured at each visit
Time frame: Up to 140 days
Bowel Function Index (BFI) will be recorded at each visit
Time frame: Up to 140 days
The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF
Time frame: Up to 140 days
The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded
Time frame: Up to 140 days
Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories)
Time frame: Up to 140 days
The patient satisfaction will be evaluated by patient in 7 categories
Time frame: Up to 140 days
The patient's quality of life will be evaluated via the EQ-5D questionnaire
Time frame: Up to 140 days
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 13 Nov 2013.
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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 Severe Pain, run by Mundipharma CVA at 1 site in Belgium.
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 0 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 13 Nov 2013. 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 Belgium. 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?
To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain (time frame: Up to 140 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 13 Nov 2013.