Severe, Chronic PainMATRIX IINCT00556270

Efficacy of Matrifen in Patients Older Than 18 Years With Severe, Chronic Pain

An observational study of Severe, Chronic Pain, run by Nycomed at 815 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of the study is to evaluate the efficacy and safety of matrifen in patients with severe and chronic pain who can only be sufficiently treated with opioid analgesics (WHO class 3). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe, Chronic Pain
What is being tested?: Matrifen
How many people: 3,000 participants
Where: 815 sitesGermany
Study dates: Nov 2007to May 2008
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: Outpatients

Main inclusion criteria:

Patients with severe, chronic pain

Main exclusion criteria:

Hypersensitivity of fentanyl
Co-administration of monoaminooxidase-inhibitors
Pregnancy
Respiratory depression
Chronic obstructive pulmonary disease (COPD)
Drug abuse
Impairment of CNS functions
Other criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)

Trial locations and contacts

815 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Germany300 sites

"Nycomed Deutschland GmbH"
Aachen, 52078
"Nycomed Deutschland GmbH"
Aalen, 73430
"Nycomed Deutschland GmbH"
Achim, 28832
"Nycomed Deutschland GmbH"
Ahaus, 48683
"Nycomed Deutschland GmbH"
Ahlen, 59229
"Nycomed Deutschland GmbH"
Aicha, 94529
"Nycomed Deutschland GmbH"
Albstadt, 72459
"Nycomed Deutschland GmbH"
Albstadt, 72461
"Nycomed Deutschland GmbH"
Alfeld, 31061
"Nycomed Deutschland GmbH"
Alfhausen, 49594
"Nycomed Deutschland GmbH"
Altdorf, 84032
"Nycomed Deutschland GmbH"
Altenburg, 04600
"Nycomed Deutschland GmbH"
Altenstadt, 63674
"Nycomed Deutschland GmbH"
Altlußheim, 68804
"Nycomed Deutschland GmbH"
Alzenau in Unterfranken, 63755
"Nycomed Deutschland GmbH"
Amorbach, 63916
"Nycomed Deutschland GmbH"
Angermünde, 16278
"Nycomed Deutschland GmbH"
Anklam, 17389
"Nycomed Deutschland GmbH"
Annweiler am Trifels, 76855
"Nycomed Deutschland GmbH"
Ansbach, 91522
"Nycomed Deutschland GmbH"
Apolda, 99510
"Nycomed Deutschland GmbH"
Arnsberg, 59821
"Nycomed Deutschland GmbH"
Arnsdorf, 01477
"Nycomed Deutschland GmbH"
Arnstadt, 99310
"Nycomed Deutschland GmbH"
Aschendorf, 26871
"Nycomed Deutschland GmbH"
Aßlar, 35614
"Nycomed Deutschland GmbH"
Attenkirchen, 85395
"Nycomed Deutschland GmbH"
Aue, 08280
"Nycomed Deutschland GmbH"
Auerbach, 08209
"Nycomed Deutschland GmbH"
Augsburg, 86159
"Nycomed Deutschland GmbH"
Augsburg, 86161
"Nycomed Deutschland GmbH"
Augsburg, 86167
"Nycomed Deutschland GmbH"
Augsburg, 86199
"Nycomed Deutschland GmbH"
Aumühle, 21521
"Nycomed Deutschland GmbH"
Aurich, 26603
"Nycomed Deutschland GmbH"
Bad Arolsen, 34454
"Nycomed Deutschland GmbH"
Bad Bederkesa, 27624
"Nycomed Deutschland GmbH"
Bad Berka, 99438
"Nycomed Deutschland GmbH"
Bad Bevensen, 29549
"Nycomed Deutschland GmbH"
Bad Dürrenberg, 06231
"Nycomed Deutschland GmbH"
Bad Dürrheim, 78073
"Nycomed Deutschland GmbH"
Bad Ems, 56130
"Nycomed Deutschland GmbH"
Bad Essen, 49152
"Nycomed Deutschland GmbH"
Bad Fallingbostel, 29683
"Nycomed Deutschland GmbH"
Bad Frankenhausen, 06567
"Nycomed Deutschland GmbH"
Bad Hersfeld, 36251
"Nycomed Deutschland GmbH"
Bad Krozingen, 79189
"Nycomed Deutschland GmbH"
Bad Langensalza, 99947
"Nycomed Deutschland GmbH"
Bad Lauterberg im Harz, 37431
"Nycomed Deutschland GmbH"
Bad Liebenwerda, 04924
"Nycomed Deutschland GmbH"
Bad Lippspringe, 33175
"Nycomed Deutschland GmbH"
Bad Marienberg, 56470
"Nycomed Deutschland GmbH"
Bad Oeynhausen, 32545
"Nycomed Deutschland GmbH"
Bad Oeynhausen, 32547
"Nycomed Deutschland GmbH"
Bad Oldesloe, 23843
"Nycomed Deutschland GmbH"
Bad Pyrmont, 31812
"Nycomed Deutschland GmbH"
Bad Sachsa, 37441
"Nycomed Deutschland GmbH"
Bad Salzuflen, 32108
"Nycomed Deutschland GmbH"
Bad Salzungen, 36433
"Nycomed Deutschland GmbH"
Bad Schwalbach, 65307
"Nycomed Deutschland GmbH"
Bad Tennstedt, 99955
"Nycomed Deutschland GmbH"
Bahrdorf, 38459
"Nycomed Deutschland GmbH"
Balingen, 72336
"Nycomed Deutschland GmbH"
Ballstädt, 99869
"Nycomed Deutschland GmbH"
Bamberg, 96047
"Nycomed Deutschland GmbH"
Bargstedt, 21698
"Nycomed Deutschland GmbH"
Barnstädt, 06268
"Nycomed Deutschland GmbH"
Barsinghausen, 30890
"Nycomed Deutschland GmbH"
Bergfelde, 16562
"Nycomed Deutschland GmbH"
Bergisch Gladbach, 51465
"Nycomed Deutschland GmbH"
Bergrheinfeld, 97493
"Nycomed Deutschland GmbH"
Berlin, 10247
"Nycomed Deutschland GmbH"
Berlin, 10249
"Nycomed Deutschland GmbH"
Berlin, 10315
"Nycomed Deutschland GmbH"
Berlin, 10317
"Nycomed Deutschland GmbH"
Berlin, 10318
"Nycomed Deutschland GmbH"
Berlin, 10319
"Nycomed Deutschland GmbH"
Berlin, 10365
"Nycomed Deutschland GmbH"
Berlin, 10405
"Nycomed Deutschland GmbH"
Berlin, 10407
"Nycomed Deutschland GmbH"
Berlin, 10409
"Nycomed Deutschland GmbH"
Berlin, 10437
"Nycomed Deutschland GmbH"
Berlin, 10557
"Nycomed Deutschland GmbH"
Berlin, 10587
"Nycomed Deutschland GmbH"
Berlin, 10715
"Nycomed Deutschland GmbH"
Berlin, 10717
"Nycomed Deutschland GmbH"
Berlin, 10779
"Nycomed Deutschland GmbH"
Berlin, 10787
"Nycomed Deutschland GmbH"
Berlin, 10961
"Nycomed Deutschland GmbH"
Berlin, 10997
"Nycomed Deutschland GmbH"
Berlin, 12047
"Nycomed Deutschland GmbH"
Berlin, 12101
"Nycomed Deutschland GmbH"
Berlin, 12103
"Nycomed Deutschland GmbH"
Berlin, 12107
"Nycomed Deutschland GmbH"
Berlin, 12109
"Nycomed Deutschland GmbH"
Berlin, 12161
"Nycomed Deutschland GmbH"
Berlin, 12163
"Nycomed Deutschland GmbH"
Berlin, 12277
"Nycomed Deutschland GmbH"
Berlin, 12347
"Nycomed Deutschland GmbH"
Berlin, 12439
"Nycomed Deutschland GmbH"
Berlin, 12459
"Nycomed Deutschland GmbH"
Berlin, 12587
"Nycomed Deutschland GmbH"
Berlin, 12623
"Nycomed Deutschland GmbH"
Berlin, 12627
"Nycomed Deutschland GmbH"
Berlin, 12683
"Nycomed Deutschland GmbH"
Berlin, 13055
"Nycomed Deutschland GmbH"
Berlin, 13125
"Nycomed Deutschland GmbH"
Berlin, 13127
"Nycomed Deutschland GmbH"
Berlin, 13187
"Nycomed Deutschland GmbH"
Berlin, 13189
"Nycomed Deutschland GmbH"
Berlin, 13353
"Nycomed Deutschland GmbH"
Berlin, 13357
"Nycomed Deutschland GmbH"
Berlin, 13409
"Nycomed Deutschland GmbH"
Berlin, 13437
"Nycomed Deutschland GmbH"
Berlin, 13439
"Nycomed Deutschland GmbH"
Berlin, 13467
"Nycomed Deutschland GmbH"
Berlin, 13469
"Nycomed Deutschland GmbH"
Berlin, 13507
"Nycomed Deutschland GmbH"
Berlin, 13509
"Nycomed Deutschland GmbH"
Berlin, 13583
"Nycomed Deutschland GmbH"
Berlin, 14089
"Nycomed Deutschland GmbH"
Berlin, 14129
"Nycomed Deutschland GmbH"
Berlin, 14163
"Nycomed Deutschland GmbH"
Berlin, 14169
"Nycomed Deutschland GmbH"
Berlin, 14199
"Nycomed Deutschland GmbH"
Berne, 27804
"Nycomed Deutschland GmbH"
Bevern, 37639
"Nycomed Deutschland GmbH"
Beverungen, 37688
"Nycomed Deutschland GmbH"
Biberach, 88400
"Nycomed Deutschland GmbH"
Bielefeld, 33739
"Nycomed Deutschland GmbH"
Bischofswerda, 01877
"Nycomed Deutschland GmbH"
Bisingen, 72406
"Nycomed Deutschland GmbH"
Bitburg, 54634
"Nycomed Deutschland GmbH"
Blankenburg, 38889
"Nycomed Deutschland GmbH"
Bobenheim-Roxheim, 67240
"Nycomed Deutschland GmbH"
Bobritzsch, 09627
"Nycomed Deutschland GmbH"
Bochum, 44787
"Nycomed Deutschland GmbH"
Bochum, 44807
"Nycomed Deutschland GmbH"
Bockau, 08324
"Nycomed Deutschland GmbH"
Böhlen, 04564
"Nycomed Deutschland GmbH"
Bohmte, 49163
"Nycomed Deutschland GmbH"
Bottrop, 46240
"Nycomed Deutschland GmbH"
Bramsche, 49565
"Nycomed Deutschland GmbH"
Brand-Erbisdorf, 09618
"Nycomed Deutschland GmbH"
Braunsbedra, 06242
"Nycomed Deutschland GmbH"
Braunschweig, 38106
"Nycomed Deutschland GmbH"
Braunschweig, 38124
"Nycomed Deutschland GmbH"
Bredstedt, 25821
"Nycomed Deutschland GmbH"
Breidenbach, 35236
"Nycomed Deutschland GmbH"
Breitenfelde, 23881
"Nycomed Deutschland GmbH"
Bremen, 28205
"Nycomed Deutschland GmbH"
Bremen, 28357
"Nycomed Deutschland GmbH"
Bremerhaven, 27570
"Nycomed Deutschland GmbH"
Bremerhaven, 27580
"Nycomed Deutschland GmbH"
Brüel, 19412
"Nycomed Deutschland GmbH"
Bückeburg, 31675
"Nycomed Deutschland GmbH"
Bünde, 32257
"Nycomed Deutschland GmbH"
Burg, 39288
"Nycomed Deutschland GmbH"
Burgdorf, Hanover, 31303
"Nycomed Deutschland GmbH"
Burgstädt, 09217
"Nycomed Deutschland GmbH"
Burkhardtsdorf, 09235
"Nycomed Deutschland GmbH"
Burscheid, 51399
"Nycomed Deutschland GmbH"
Castrop-Rauxel, 44577
"Nycomed Deutschland GmbH"
Celle, 29221
"Nycomed Deutschland GmbH"
Celle, 29223
"Nycomed Deutschland GmbH"
Chemnitz, 09111
"Nycomed Deutschland GmbH"
Chemnitz, 09113
"Nycomed Deutschland GmbH"
Chemnitz, 09123
"Nycomed Deutschland GmbH"
Chemnitz, 09127
"Nycomed Deutschland GmbH"
Chemnitz, 09130
"Nycomed Deutschland GmbH"
Coesfeld, 48653
"Nycomed Deutschland GmbH"
Cologne, 50679
"Nycomed Deutschland GmbH"
Cologne, 50825
"Nycomed Deutschland GmbH"
Cologne, 51063
"Nycomed Deutschland GmbH"
Cologne, 51065
"Nycomed Deutschland GmbH"
Cologne, 51069
"Nycomed Deutschland GmbH"
Cologne, 51103
"Nycomed Deutschland GmbH"
Coswig, 06869
"Nycomed Deutschland GmbH"
Cottbus, 03044
"Nycomed Deutschland GmbH"
Cuxhaven, 27478
"Nycomed Deutschland GmbH"
Dabel, 19406
"Nycomed Deutschland GmbH"
Darmstadt, 64293
"Nycomed Deutschland GmbH"
Daun, 54550
"Nycomed Deutschland GmbH"
Dautphetal, 35232
"Nycomed Deutschland GmbH"
Delitzsch, 04509
"Nycomed Deutschland GmbH"
Demmin, 17109
"Nycomed Deutschland GmbH"
Denkendorf, 73770
"Nycomed Deutschland GmbH"
Denzlingen, 79211
"Nycomed Deutschland GmbH"
Dessau, 06844
"Nycomed Deutschland GmbH"
Dessau, 06847
"Nycomed Deutschland GmbH"
Dettenheim, 76706
"Nycomed Deutschland GmbH"
Diepholz, 49356
"Nycomed Deutschland GmbH"
Dingolfing, 84130
"Nycomed Deutschland GmbH"
Dörentrup, 32694
"Nycomed Deutschland GmbH"
Dorsten, 46282
"Nycomed Deutschland GmbH"
Dortmund, 44135
"Nycomed Deutschland GmbH"
Dortmund, 44137
"Nycomed Deutschland GmbH"
Dortmund, 44139
"Nycomed Deutschland GmbH"
Dortmund, 44143
"Nycomed Deutschland GmbH"
Dortmund, 44145
"Nycomed Deutschland GmbH"
Dortmund, 44269
"Nycomed Deutschland GmbH"
Dörzbach, 74677
"Nycomed Deutschland GmbH"
Dresden, 01067
"Nycomed Deutschland GmbH"
Dresden, 01097
"Nycomed Deutschland GmbH"
Dresden, 01109
"Nycomed Deutschland GmbH"
Dresden, 01156
"Nycomed Deutschland GmbH"
Dresden, 01157
"Nycomed Deutschland GmbH"
Dresden, 01159
"Nycomed Deutschland GmbH"
Dresden, 01169
"Nycomed Deutschland GmbH"
Dresden, 01187
"Nycomed Deutschland GmbH"
Dresden, 01219
"Nycomed Deutschland GmbH"
Dresden, 01277
"Nycomed Deutschland GmbH"
Dresden, 01279
"Nycomed Deutschland GmbH"
Dresden, 01326
"Nycomed Deutschland GmbH"
Ducherow, 17398
"Nycomed Deutschland GmbH"
Dudenhofen, 67373
"Nycomed Deutschland GmbH"
Duisburg, 47051
"Nycomed Deutschland GmbH"
Duisburg, 47057
"Nycomed Deutschland GmbH"
Duisburg, 47198
"Nycomed Deutschland GmbH"
Duisburg, 47226
"Nycomed Deutschland GmbH"
Duisburg, 47269
"Nycomed Deutschland GmbH"
Durmersheim, 76448
"Nycomed Deutschland GmbH"
Dürrröhrsdorf, 01833
"Nycomed Deutschland GmbH"
Düsseldorf, 40223
"Nycomed Deutschland GmbH"
Düsseldorf, 40589
"Nycomed Deutschland GmbH"
Düsseldorf, 40629
"Nycomed Deutschland GmbH"
Ebeleben, 99713
"Nycomed Deutschland GmbH"
Eberbach, 69412
"Nycomed Deutschland GmbH"
Ebersbach, 02730
"Nycomed Deutschland GmbH"
Ebersbach, 73061
"Nycomed Deutschland GmbH"
Eberstadt, 74246
"Nycomed Deutschland GmbH"
Eberswalde, 16225
"Nycomed Deutschland GmbH"
Eddelak, 25715
"Nycomed Deutschland GmbH"
Edenkoben, 67480
"Nycomed Deutschland GmbH"
Ehra-Lessien, 38468
"Nycomed Deutschland GmbH"
Eimsheim, 55278
"Nycomed Deutschland GmbH"
Eisenach, 99817
"Nycomed Deutschland GmbH"
Eisenberg, 67304
"Nycomed Deutschland GmbH"
Eisenhüttenstadt, 15890
"Nycomed Deutschland GmbH"
Eisleben Lutherstadt, 06295
"Nycomed Deutschland GmbH"
Eiterfeld, 36132
"Nycomed Deutschland GmbH"
Ellefeld, 08236
"Nycomed Deutschland GmbH"
Ellerstadt, 67158
"Nycomed Deutschland GmbH"
Ellwangen, 73479
"Nycomed Deutschland GmbH"
Elstra, 01920
"Nycomed Deutschland GmbH"
Elterlein, 09481
"Nycomed Deutschland GmbH"
Emleben, 99869
"Nycomed Deutschland GmbH"
Emsdetten, 48282
"Nycomed Deutschland GmbH"
Emstek, 49685
"Nycomed Deutschland GmbH"
Engelskirchen, 51766
"Nycomed Deutschland GmbH"
Enger, 32130
"Nycomed Deutschland GmbH"
Eningen unter Achalm, 72800
"Nycomed Deutschland GmbH"
Enkirch, 56850
"Nycomed Deutschland GmbH"
Ennepetal, 58256
"Nycomed Deutschland GmbH"
Eppstein, 65817
"Nycomed Deutschland GmbH"
Erfurt, 99084
"Nycomed Deutschland GmbH"
Erfurt, 99085
"Nycomed Deutschland GmbH"
Erfurt, 99094
"Nycomed Deutschland GmbH"
Erfurt, 99096
"Nycomed Deutschland GmbH"
Erfurt, 99099
"Nycomed Deutschland GmbH"
Eschelbronn, 74927
"Nycomed Deutschland GmbH"
Eschwege, 37269
"Nycomed Deutschland GmbH"
Esens, 26427
"Nycomed Deutschland GmbH"
Espelkamp, 32339
"Nycomed Deutschland GmbH"
Essen, 45136
"Nycomed Deutschland GmbH"
Essen, 45239
"Nycomed Deutschland GmbH"
Essen, 45326
"Nycomed Deutschland GmbH"
Essen, 45356
"Nycomed Deutschland GmbH"
Falkensee, 14612
"Nycomed Deutschland GmbH"
Fehrbellin, 16833
"Nycomed Deutschland GmbH"
Finsterwalde, 03238
"Nycomed Deutschland GmbH"
Floh-Seligenthal, 98593
"Nycomed Deutschland GmbH"
Flonheim, 55237
"Nycomed Deutschland GmbH"
Framersheim, 55234
"Nycomed Deutschland GmbH"
Frankenberg, 35066
"Nycomed Deutschland GmbH"
Frankfurt, 15230
"Nycomed Deutschland GmbH"
Frankfurt, 60316
"Nycomed Deutschland GmbH"
Frankfurt, 60439
"Nycomed Deutschland GmbH"
Frankfurt, 60487
"Nycomed Deutschland GmbH"
Frankfurt, 60529
"Nycomed Deutschland GmbH"
Freiberg, 09599
"Nycomed Deutschland GmbH"
Freiburg im Breisgau, 79102
"Nycomed Deutschland GmbH"
Freiburg im Breisgau, 79115
"Nycomed Deutschland GmbH"
Freising, 85354
"Nycomed Deutschland GmbH"
Freyburg, 06632
"Nycomed Deutschland GmbH"
Friedeburg, 26446
"Nycomed Deutschland GmbH"
Friedrichshafen, 88045
"Nycomed Deutschland GmbH"
Friedrichshafen, 88046
"Nycomed Deutschland GmbH"
Friedrichsthal, 66299
"Nycomed Deutschland GmbH"
Fürstenberg, 16798
"Nycomed Deutschland GmbH"
Fürstenwalde, 15517
"Nycomed Deutschland GmbH"
Furth im Wald, 93437
"Nycomed Deutschland GmbH"
Garbsen, 30823
"Nycomed Deutschland GmbH"
Garmisch-Partenkirchen, 82467
"Nycomed Deutschland GmbH"
Gebesee, 99189
"Nycomed Deutschland GmbH"
Geisenhausen, 84144
"Nycomed Deutschland GmbH"
Geislingen, 73312
"Nycomed Deutschland GmbH"
Gelnhausen, 63571
"Nycomed Deutschland GmbH"
Gelsenkirchen, 45881
"Nycomed Deutschland GmbH"
Gelsenkirchen, 45883

Other trials in Germany

About this study

Official title: Matrifen for Therapy of Severe, Chronic Pain.

The aim of the study is to evaluate the efficacy and safety of matrifen in patients with severe and chronic pain who can only be sufficiently treated with opioid analgesics (WHO class 3).

Conditions: Severe, Chronic Pain
Being tested: Matrifen
Keywords: pain, fentanyl, transdermal patch
Medical subject headings: Chronic Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MatrifenDrug
as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.2)

Study groups in NCT00556270
Study group	Role	What they receive
Matrix II		Not described Receives: Drug: Matrifen

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment success, efficacy of Matrifen
Measured: within 1 month

Secondary outcomes (1)

Safety and tolerability of fentanyl and the transdermal system, quality of life
Measured: within 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007May 2008

First posted9 Nov 2007 (estimated)
Study startNov 2007
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Severe, Chronic 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: Case only
Time perspective: Prospective
Enrolment: 3,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00556270
Sponsor's protocol ID: Matri Matrix II 07/10
Acronym: MATRIX II
Status last verified: May 2012
First submitted: 8 Nov 2007
Last updated: 7 May 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period
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Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
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All Severe, Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Matrifen for Therapy of Severe, Chronic Pain.
ClinicalTrials.gov ID: NCT00556270
Acronym / sponsor ID: MATRIX II / Matri Matrix II 07/10
Conditions: Severe, Chronic Pain
Keywords: pain, fentanyl, transdermal patch
Study type: Observational
Recruitment status: Completed
Enrolment: 3,000 participants (estimated)
Lead sponsor: NycomedIndustry (pharma, biotech, devices)
Study start: Nov 2007
Study completion: May 2008 (actual)
First posted: 9 Nov 2007 (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 aim of the study is to evaluate the efficacy and safety of matrifen in patients with severe and chronic pain who can only be sufficiently treated with opioid analgesics (WHO class 3).

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Matrix II	–	Drug: Matrifen

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Outpatients

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
Matrifenas defined in the Summary of Product Characteristics (Fachinformation Chapter 4.2)	Drug	Matrix II

Primary outcome

Treatment success, efficacy of Matrifen
Time frame: within 1 month

1 secondary outcome

Safety and tolerability of fentanyl and the transdermal system, quality of life
Time frame: within 1 month

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 May 2012.

Related trials for Severe, Chronic Pain

Not yet recruiting
Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period
Severe Pain, Cesarean Section Complications
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)
Active, not recruiting
Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty
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RecruitingPhase 2
MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
Post Traumatic Stress Disorder

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.

Dr. Thomas D. Bethke, PhD, MD study director

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

815 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Severe, Chronic Pain, run by Nycomed at 815 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 815 sites in Germany. 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?

Treatment success, efficacy of Matrifen (time frame: within 1 month). 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 NCT00556270.

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 May 2012.