Matrifen® for Therapy of Severe Chronic Pain® (Matrix LQ)
This study has been completed.
Sponsor:
Nycomed: A Takeda Company
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00699335
First received: June 17, 2008
Last updated: May 4, 2012
Last verified: May 2012
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Results First Received: July 15, 2010
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Cohort; Time Perspective: Prospective |
| Condition: |
Severe Chronic Pain |
| Intervention: |
Drug: Fentanyl |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Matrifen® | All patients enrolled |
Participant Flow: Overall Study
| Matrifen® | |
|---|---|
| STARTED | 5308 |
| COMPLETED | 5080 |
| NOT COMPLETED | 228 |
| Combination of multiple reasons | 176 |
| Missing data | 52 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Matrifen® | All patients enrolled |
Baseline Measures
| Matrifen® | |
|---|---|
|
Number of Participants
[units: participants] |
5308 |
|
Age
[1] [units: years] Mean ± Standard Deviation |
70.3 ± 13.2 |
|
Gender
[2] [units: participants] |
|
| Female | 3334 |
| Male | 1971 |
|
Type of pain
[3] [units: participants] |
|
| Severe pain when moving | 3751 |
| Pain caused by a tumor | 1359 |
| Other type of pain | 877 |
| Missing data | 7 |
|
Underlying disease
[4] [units: Participants] |
|
| Musculoskeletal disorders | 3396 |
| Tumor | 1416 |
| Neurological disorders | 514 |
| Dermatological disorders | 51 |
| Underlying disease NOS | 210 |
| Missing data | 371 |
| [1] | The reported values are related to the number of 5174 subjects. This number differs from the overall number of baseline participants due to missing data for 134 subjects. |
|---|---|
| [2] | The reported values are related to the number of 5305 subjects. This number differs from the overall number of baseline participants due to missing data for 3 subjects. |
| [3] | Multiple types of pain possible. One participant can have more than one type of pain. |
| [4] | Multiple diseases possible. One participant can have more than one underlying disease. |
Outcome Measures
| 1. Primary: | Patient's Assessment of Pain Severity Score [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 2. Primary: | Physician's Final Assessment of the Efficacy of Therapy With Matrifen® [ Time Frame: After 4 week therapy with Matrifen® ] |
| 3. Primary: | EQ-5D (Optional): Domain Mobility [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 4. Primary: | EQ-5D (Optional): Domain Mobility [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 5. Primary: | EQ-5D (Optional): Domain Self Care [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 6. Primary: | EQ-5D (Optional): Domain Self Care [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 7. Primary: | EQ-5D (Optional): Domain Usual Activities [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 8. Primary: | EQ-5D (Optional): Domain Usual Activities [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 9. Primary: | EQ-5D (Optional): Pain / Discomfort [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 10. Primary: | EQ-5D (Optional): Pain / Discomfort [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 11. Primary: | EQ-5D (Optional): Domain Anxiety / Depression [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 12. Primary: | EQ-5D (Optional): Domain Anxiety / Depression [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 13. Primary: | EQ-5D (Optional): European Index Score [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 14. Primary: | EQ-5D (Optional): Visual Analogue Scale [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] |
| 15. Secondary: | Physician's Assessment of the Skin Tolerability of the Fentanyl-patches [ Time Frame: After 4 week therapy with Matrifen® ] |
| 16. Secondary: | Patient's Assessment of the Acceptance of the Fentanyl-patches [ Time Frame: After 4 week therapy with Matrifen® ] |
| 17. Secondary: | Physician's Assessment of the Adhesion Properties of the Fentanyl-patches [ Time Frame: After 4 week therapy with Matrifen® ] |
| 18. Secondary: | Physician's Final Assessment of the Tolerability of Matrifen® [ Time Frame: After 4 week therapy with Matrifen® ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
Results Point of Contact:
Name/Title: Medical Responsible
Organization: Nycomed Deutschland GmbH
phone: +49 7531 3666 0
e-mail: clinicaltrials@nycomed.com
Organization: Nycomed Deutschland GmbH
phone: +49 7531 3666 0
e-mail: clinicaltrials@nycomed.com
No publications provided
| Responsible Party: | Medical Responsible, Nycomed Deutschland GmbH |
| ClinicalTrials.gov Identifier: | NCT00699335 History of Changes |
| Other Study ID Numbers: | Matrix LQ, FT-1300-028 |
| Study First Received: | June 17, 2008 |
| Results First Received: | July 15, 2010 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |