Chronic Severe PainNCT01710917
A Non-interventional, Observational Study for Quality of Life (Overall Health Assessment) in Patients With Chronic Severe Pain During Targinact® Treatment
An observational study of Chronic 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 quality of life 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
- Chronic Severe Pain
- What is being tested?
- Targinact® (oxycodon/naloxon)
- How many people
- 1,800 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2012to Jan 2014
- 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: Primary and Secondary care
Who may be able to join
- Patients enrolled in the study are patients who
- are eligible for Targinact® treatment according to the Targinact® SPC AND
- who have previously been treated with WHO step 1, 2 or 3 analgesics
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Maggie C Wilson contact
Jill Kiteley contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Brussels (UZ Brussel), Belgium
Brussels
About this study
Official title: The Efficacy of Targinact® Treatment With Respect to Quality of Life (Overall Health Assessment) in Chronic Severe Pain Patients Compared to Previous Analgesic Treatment: a Non-interventional, Observational Study.
This non-interventional, observational study evaluates the efficacy of Targinact with regard to quality of life 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 during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are overall health assessment of the patient, pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment.
- Conditions
- Chronic Severe Pain
- Being tested
- Targinact® (oxycodon/naloxon)
- Keywords
- Chronic pain, Severe pain, Oxycodon, Naloxon, Opioid-induced constipation, Opioid, Quality of life, Laxative, Analgesic rescue medication
- Medical subject headings
- Chronic Pain, Pain, Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targinact® (oxycodon/naloxon)Drug
| Study group | Role | What they receive |
|---|---|---|
| Targinact® (oxycodon/naloxon) | Not described Receives: Drug: Targinact® (oxycodon/naloxon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of Targinact® treatment
The primary parameter to assess the efficacy of Targinact® treatment with respect to the quality of life (overall health assessment/EQ-VAS) in patients with chronic severe pain compared to previous analgesic treatment is the absolute change in overall health score (0-100) attributed by patients during Targinact® treatment compared to previous analgesic treatment.
During each visit, patients will be asked to score their overall health state between 0 (worst health state imaginable) and 100 (best health state imaginable). The absolute changes in overall health assessment from baseline at V2 and V3 will be used to compare health assessment during Targinact® treatment.
Measured: 12 weeks
Secondary outcomes (6)
• To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)
To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)
Measured: 12 weeks
To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)
To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)
Measured: 12 weeks
To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)
To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)
Measured: 12 weeks
To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)
To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)
Measured: 12 weeks
To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)
To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)
Measured: 12 weeks
To assess safety of Targinact® treatment (by physician)
Safety will be assessed by documentation of adverse events, collected via spontaneous reports and patient documentation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma CVA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710917
- Sponsor's protocol ID
- OXN9512
- Status last verified
- Nov 2013
- First submitted
- 15 Oct 2012
- Last updated
- 13 Nov 2013
- Results posted
- No
Publications
Poelaert J, Koopmans-Klein G, Dioh A, Louis F, Gorissen M, Loge D, Van Op den Bosch J, van Megen YJ. Treatment with prolonged-release oxycodone/naloxone improves pain relief and opioid-induced constipation compared with prolonged-release oxycodone in patients with chronic severe pain and laxative-refractory constipation. Clin Ther. 2015 Apr 1;37(4):784-92. doi: 10.1016/j.clinthera.2015.02.010. Epub 2015 Mar 7.
PubMed 25757607
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 of Targinact® Treatment With Respect to Quality of Life (Overall Health Assessment) in Chronic Severe Pain Patients Compared to Previous Analgesic Treatment: a Non-interventional, Observational Study.
- ClinicalTrials.gov ID
- NCT01710917
- Acronym / sponsor ID
- OXN9512
- Conditions
- Chronic Severe Pain
- Keywords
- Chronic pain, Severe pain, Oxycodon, Naloxon, Opioid-induced constipation, Opioid, Quality of life, Laxative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Mundipharma CVAUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 19 Oct 2012 (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 quality of life in daily clinical practice in Belgium compared to the previous analgesic treatment.
Detailed description
Patients are treated with Targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are overall health assessment of the patient, pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targinact® (oxycodon/naloxon) | – | Drug: Targinact® (oxycodon/naloxon) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary and Secondary care
Key inclusion criteria (3 listed)
- Patients enrolled in the study are patients who
- are eligible for Targinact® treatment according to the Targinact® SPC AND
- who have previously been treated with WHO step 1, 2 or 3 analgesics
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® (oxycodon/naloxon) | Drug | Targinact® (oxycodon/naloxon) |
Primary outcome
Assess the efficacy of Targinact® treatment
Time frame: 12 weeks
The primary parameter to assess the efficacy of Targinact® treatment with respect to the quality of life (overall health assessment/EQ-VAS) in patients with chronic severe pain compared to previous analgesic treatment is the absolute change in overall health score (0-100) attributed by patients during Targinact® treatment compared to previous analgesic treatment. During each visit, patients will be asked to score their overall health state between 0 (worst health state imaginable) and 100 (best health state imaginable). The absolute changes in overall health assessment from baseline at V2 and V3 will be used to compare health assessment during Targinact® treatment.
6 secondary outcomes
• To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)
Time frame: 12 weeks
To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)
Time frame: 12 weeks
To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)
Time frame: 12 weeks
To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)
Time frame: 12 weeks
To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)
Time frame: 12 weeks
To assess safety of Targinact® treatment (by physician)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Derived from this study: PubMed 25757607Poelaert J, Koopmans-Klein G, Dioh A, Louis F, Gorissen M, Loge D, Van Op den Bosch J, van Megen YJ. Treatment with prolonged-release oxycodone/naloxone improves pain relief and opioid-induced constipation compared with prolonged-release oxycodone in patients with chronic severe pain and laxative-refractory constipation. Clin Ther. 2015 Apr 1;37(4):784-92. doi: 10.1016/j.clinthera.2015.02.010. Epub 2015 Mar 7.
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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.
Maggie C Wilson contact
Jill Kiteley contact
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 Chronic 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maggie C Wilson (Info@contact-clinical-trials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the efficacy of Targinact® treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01710917, which also lists 1 linked publication.
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.