Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00699335
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2008-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Matrifen® for Therapy of Severe Chronic Pain®
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@nycomed.com', 'phone': '+49 7531 3666 0', 'title': 'Medical Responsible', 'organization': 'Nycomed Deutschland GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'First until last visit (planned: 4 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Matrifen®', 'description': 'Patients included and treated with at least one application of Matrifen®', 'otherNumAtRisk': 5308, 'otherNumAffected': 0, 'seriousNumAtRisk': 5308, 'seriousNumAffected': 80}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': "Dementia Alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Prosthesis implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Patient's Assessment of Pain Severity Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '5226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen®', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'Start of therapy', 'categories': [{'measurements': [{'value': '7.12', 'spread': '1.52', 'groupId': 'OG000'}]}]}, {'title': 'End of study', 'categories': [{'measurements': [{'value': '3.32', 'spread': '1.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'PRIMARY', 'title': "Physician's Final Assessment of the Efficacy of Therapy With Matrifen®", 'denoms': [{'units': 'Participants', 'counts': [{'value': '5308', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen®', 'description': "All patients with valid values ('as observed')"}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '2530', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '2273', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfactory', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 4 week therapy with Matrifen®', 'description': 'Assessment on a scale: Excellent, good, satisfactory, dissatisfactory', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients included and treated, intention to treat, missing values not imputed'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Domain Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}, {'value': '3435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen® / Initial Visit', 'description': 'All patients with valid values at first and last visit'}, {'id': 'OG001', 'title': 'Matrifen® / Final Visit', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'I have no problems in walking around', 'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000'}, {'value': '1294', 'groupId': 'OG001'}]}]}, {'title': 'I have some problems in walking around', 'categories': [{'measurements': [{'value': '2779', 'groupId': 'OG000'}, {'value': '1923', 'groupId': 'OG001'}]}]}, {'title': 'I am confined to bed', 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no problems in walking around\n2. I have some problems in walking around\n3. I am confined to bed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Domain Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}, {'value': '3435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen® / Initial Visit', 'description': 'All patients with valid values at first and last visit'}, {'id': 'OG001', 'title': 'Matrifen® / Final Visit', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no problems in walking around\n2. I have some problems in walking around\n3. I am confined to bed', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Domain Self Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}, {'value': '3435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen® / Initial Visit', 'description': 'All patients with valid values at first and last visit'}, {'id': 'OG001', 'title': 'Matrifen® / Final Visit', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'I have no problems with self-care', 'categories': [{'measurements': [{'value': '682', 'groupId': 'OG000'}, {'value': '1709', 'groupId': 'OG001'}]}]}, {'title': 'I have some problems washing or dressing myself', 'categories': [{'measurements': [{'value': '2152', 'groupId': 'OG000'}, {'value': '1461', 'groupId': 'OG001'}]}]}, {'title': 'I am unable to wash or dress myself', 'categories': [{'measurements': [{'value': '601', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no problems with self-care\n2. I have some problems washing or dressing myself\n3. I am unable to wash or dress myself', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Domain Self Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}, {'value': '3435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen® / Initial Visit', 'description': 'All patients with valid values at first and last visit'}, {'id': 'OG001', 'title': 'Matrifen® / Final Visit', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'categories': [{'measurements': [{'value': '1.98', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no problems with self-care\n2. I have some problems washing or dressing myself\n3. I am unable to wash or dress myself', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Domain Usual Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}, {'value': '3435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen® / Initial Visit', 'description': 'All patients with valid values at first and last visit'}, {'id': 'OG001', 'title': 'Matrifen® / Final Visit', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'I have no problems with performing my usual activi', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '1070', 'groupId': 'OG001'}]}]}, {'title': 'I have some problems with performing my usual acti', 'categories': [{'measurements': [{'value': '2227', 'groupId': 'OG000'}, {'value': '1973', 'groupId': 'OG001'}]}]}, {'title': 'I am unable to perform my usual activities', 'categories': [{'measurements': [{'value': '1066', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no problems with performing my usual activities\n2. I have some problems with performing my usual activities\n3. I am unable to perform my usual activities', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Domain Usual Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}, {'value': '3435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen® / Initial Visit', 'description': 'All patients with valid values at first and last visit'}, {'id': 'OG001', 'title': 'Matrifen® / Final Visit', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'categories': [{'measurements': [{'value': '2.27', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no problems with performing my usual activities\n2. I have some problems with performing my usual activities\n3. I am unable to perform my usual activities', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Pain / Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}, {'value': '3435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen® / Initial Visit', 'description': 'All patients with valid values at first and last visit'}, {'id': 'OG001', 'title': 'Matrifen® / Final Visit', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'I have no pain or discomfort', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '749', 'groupId': 'OG001'}]}]}, {'title': 'I have moderate pain or discomfort', 'categories': [{'measurements': [{'value': '1104', 'groupId': 'OG000'}, {'value': '2503', 'groupId': 'OG001'}]}]}, {'title': 'I have extreme pain or discomfort', 'categories': [{'measurements': [{'value': '2313', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no pain or discomfort\n2. I have moderate pain or discomfort\n3. I have extreme pain or discomfort', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Pain / Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}, {'value': '3435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen® / Initial Visit', 'description': 'All patients with valid values at first and last visit'}, {'id': 'OG001', 'title': 'Matrifen® / Final Visit', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'categories': [{'measurements': [{'value': '2.67', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no pain or discomfort\n2. I have moderate pain or discomfort\n3. I have extreme pain or discomfort', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'SECONDARY', 'title': "Physician's Assessment of the Skin Tolerability of the Fentanyl-patches", 'denoms': [{'units': 'Participants', 'counts': [{'value': '5308', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen®', 'description': "All patients with valid values ('as observed')"}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '3403', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '1716', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfactory', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 4 week therapy with Matrifen®', 'description': 'Assessment on a scale: Excellent, good, satisfactory, dissatisfactory', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients included and treated, intention to treat, missing values not imputed'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of the Acceptance of the Fentanyl-patches", 'denoms': [{'units': 'Participants', 'counts': [{'value': '5308', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen®', 'description': "All patients with valid values ('as observed')"}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '3210', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '1725', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfactory', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 4 week therapy with Matrifen®', 'description': 'Assessment on a scale: Excellent, good, satisfactory, dissatisfactory', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients included and treated, intention to treat, missing values not imputed'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Domain Anxiety / Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}, {'value': '3435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen® / Initial Visit', 'description': 'All patients with valid values at first and last visit'}, {'id': 'OG001', 'title': 'Matrifen® / Final Visit', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'I am not anxious or depressed', 'categories': [{'measurements': [{'value': '688', 'groupId': 'OG000'}, {'value': '1920', 'groupId': 'OG001'}]}]}, {'title': 'I am moderately anxious or depressed', 'categories': [{'measurements': [{'value': '1949', 'groupId': 'OG000'}, {'value': '1409', 'groupId': 'OG001'}]}]}, {'title': 'I am extremely anxious or depressed', 'categories': [{'measurements': [{'value': '798', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I am not anxious or depressed\n2. I am moderately anxious or depressed\n3. I am extremely anxious or depressed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Domain Anxiety / Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}, {'value': '3435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen® / Initial Visit', 'description': 'All patients with valid values at first and last visit'}, {'id': 'OG001', 'title': 'Matrifen® / Final Visit', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I am not anxious or depressed\n2. I am moderately anxious or depressed\n3. I am extremely anxious or depressed', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): European Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen®', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'Initial visit', 'categories': [{'measurements': [{'value': '0.078', 'spread': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'Final visit', 'categories': [{'measurements': [{'value': '0.584', 'spread': '0.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'Index derived from the five EQ-5D-items (= mobility, self care, usual activities, pain/discomfort, anxiety/depression) resulting in a value from -1= very ill to 1=full health', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'PRIMARY', 'title': 'EQ-5D (Optional): Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3435', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen®', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'Initial visit', 'categories': [{'measurements': [{'value': '40.1', 'spread': '22.0', 'groupId': 'OG000'}]}]}, {'title': 'Final visit', 'categories': [{'measurements': [{'value': '58.8', 'spread': '20.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'SECONDARY', 'title': "Physician's Assessment of the Adhesion Properties of the Fentanyl-patches", 'denoms': [{'units': 'Participants', 'counts': [{'value': '5308', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen®', 'description': "All patients with valid values ('as observed')"}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '3274', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '1777', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfactory', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 4 week therapy with Matrifen®', 'description': 'Assessment on a scale: Excellent, good, satisfactory, dissatisfactory', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients included and treated, intention to treat, missing values not imputed'}, {'type': 'SECONDARY', 'title': "Physician's Final Assessment of the Tolerability of Matrifen®", 'denoms': [{'units': 'Participants', 'counts': [{'value': '5308', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Matrifen®', 'description': "All patients with valid values ('as observed')"}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '2866', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '2058', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfactory', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 4 week therapy with Matrifen®', 'description': 'Assessment on a scale: Excellent, good, satisfactory, dissatisfactory', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients included and treated, intention to treat, missing values not imputed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Matrifen®', 'description': 'All patients enrolled'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5308'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5080'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}]}], 'dropWithdraws': [{'type': 'Combination of multiple reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '176'}]}, {'type': 'Missing data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5308', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Matrifen®', 'description': 'All patients enrolled'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'spread': '13.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '3334', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '1971', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': '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.', 'unitOfMeasure': 'participants'}, {'title': 'Type of pain', 'classes': [{'title': 'Severe pain when moving', 'categories': [{'measurements': [{'value': '3751', 'groupId': 'BG000'}]}]}, {'title': 'Pain caused by a tumor', 'categories': [{'measurements': [{'value': '1359', 'groupId': 'BG000'}]}]}, {'title': 'Other type of pain', 'categories': [{'measurements': [{'value': '877', 'groupId': 'BG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Multiple types of pain possible. One participant can have more than one type of pain.', 'unitOfMeasure': 'participants'}, {'title': 'Underlying disease', 'classes': [{'title': 'Musculoskeletal disorders', 'categories': [{'measurements': [{'value': '3396', 'groupId': 'BG000'}]}]}, {'title': 'Tumor', 'categories': [{'measurements': [{'value': '1416', 'groupId': 'BG000'}]}]}, {'title': 'Neurological disorders', 'categories': [{'measurements': [{'value': '514', 'groupId': 'BG000'}]}]}, {'title': 'Dermatological disorders', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}, {'title': 'Underlying disease NOS', 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '371', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Multiple diseases possible. One participant can have more than one underlying disease.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2008-06-17', 'resultsFirstSubmitDate': '2010-07-15', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-07-15', 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's Assessment of Pain Severity Score", 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain'}, {'measure': "Physician's Final Assessment of the Efficacy of Therapy With Matrifen®", 'timeFrame': 'After 4 week therapy with Matrifen®', 'description': 'Assessment on a scale: Excellent, good, satisfactory, dissatisfactory'}, {'measure': 'EQ-5D (Optional): Domain Mobility', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no problems in walking around\n2. I have some problems in walking around\n3. I am confined to bed'}, {'measure': 'EQ-5D (Optional): Domain Self Care', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no problems with self-care\n2. I have some problems washing or dressing myself\n3. I am unable to wash or dress myself'}, {'measure': 'EQ-5D (Optional): Domain Usual Activities', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no problems with performing my usual activities\n2. I have some problems with performing my usual activities\n3. I am unable to perform my usual activities'}, {'measure': 'EQ-5D (Optional): Pain / Discomfort', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I have no pain or discomfort\n2. I have moderate pain or discomfort\n3. I have extreme pain or discomfort'}, {'measure': 'EQ-5D (Optional): Domain Anxiety / Depression', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).\n\nQuestions on a scale from 1-3 at initial and final visit:\n\n1. I am not anxious or depressed\n2. I am moderately anxious or depressed\n3. I am extremely anxious or depressed'}, {'measure': 'EQ-5D (Optional): European Index Score', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'Index derived from the five EQ-5D-items (= mobility, self care, usual activities, pain/discomfort, anxiety/depression) resulting in a value from -1= very ill to 1=full health'}, {'measure': 'EQ-5D (Optional): Visual Analogue Scale', 'timeFrame': 'Before and after therapy with Matrifen® (4 weeks)', 'description': 'Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status'}], 'secondaryOutcomes': [{'measure': "Physician's Assessment of the Skin Tolerability of the Fentanyl-patches", 'timeFrame': 'After 4 week therapy with Matrifen®', 'description': 'Assessment on a scale: Excellent, good, satisfactory, dissatisfactory'}, {'measure': "Patient's Assessment of the Acceptance of the Fentanyl-patches", 'timeFrame': 'After 4 week therapy with Matrifen®', 'description': 'Assessment on a scale: Excellent, good, satisfactory, dissatisfactory'}, {'measure': "Physician's Assessment of the Adhesion Properties of the Fentanyl-patches", 'timeFrame': 'After 4 week therapy with Matrifen®', 'description': 'Assessment on a scale: Excellent, good, satisfactory, dissatisfactory'}, {'measure': "Physician's Final Assessment of the Tolerability of Matrifen®", 'timeFrame': 'After 4 week therapy with Matrifen®', 'description': 'Assessment on a scale: Excellent, good, satisfactory, dissatisfactory'}]}, 'conditionsModule': {'keywords': ['pain', 'fentanyl', 'transdermal patch'], 'conditions': ['Severe Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to evaluate the efficacy and safety of Matrifen® in patients with severe and chronic pain who could only be sufficiently treated with opioid analgetics (WHO class 3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main inclusion criteria:\n\n* Outpatients with severe, chronic pain\n\nMain exclusion criteria:\n\n* Hypersensitivity to fentanyl\n* Co-administration of monoamineoxidase-inhibitors\n* Pregnancy\n* Respiratory depression\n* Chronic obstructive pulmonary disease (COPD)\n* Drug abuse\n* Impairment of CNS functions\n* Other criteria as defined in the Summary of Product Characteristics (Chapter 4.3)'}, 'identificationModule': {'nctId': 'NCT00699335', 'acronym': 'Matrix LQ', 'briefTitle': 'Matrifen® for Therapy of Severe Chronic Pain®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nycomed'}, 'officialTitle': 'Efficacy of Matrifen® in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire', 'orgStudyIdInfo': {'id': 'Matrix LQ, FT-1300-028'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73430', 'city': 'Aalen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.83777, 'lon': 10.0933}}, {'zip': '93326', 'city': 'Abensberg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.81684, 'lon': 11.8498}}, {'zip': '37139', 'city': 'Adelebsen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.58272, 'lon': 9.75461}}, {'zip': '48683', 'city': 'Ahaus', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.07936, 'lon': 7.01344}}, {'zip': '59229', 'city': 'Ahlen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.76338, 'lon': 7.8887}}, {'zip': '22926', 'city': 'Ahrensburg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 53.67661, 'lon': 10.23705}}, {'zip': '72459', 'city': 'Albstadt', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.21644, 'lon': 9.02596}}, {'zip': '52457', 'city': 'Aldenhoven', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.9, 'lon': 6.28333}}, {'zip': '31061', 'city': 'Alfeld', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.98382, 'lon': 9.81989}}, {'zip': '49594', 'city': 'Alfhausen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.5, 'lon': 7.95}}, {'zip': '90584', 'city': 'Allersberg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 49.25132, 'lon': 11.23659}}, {'zip': '36304', 'city': 'Alsfeld', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.75185, 'lon': 9.27082}}, {'zip': '84032', 'city': 'Altdorf', 'country': 'Germany', 'facility': 'Nycomed 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Bramstedt', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 53.91827, 'lon': 9.88243}}, {'zip': '04849', 'city': 'Bad Düben', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.59174, 'lon': 12.58492}}, {'zip': '67098', 'city': 'Bad Dürkheim', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 49.4618, 'lon': 8.17236}}, {'zip': '06231', 'city': 'Bad Dürrenberg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.29545, 'lon': 12.06583}}, {'zip': '78073', 'city': 'Bad Dürrheim', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.02093, 'lon': 8.53056}}, {'zip': '31707', 'city': 'Bad Eilsen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.24215, 'lon': 9.09822}}, {'zip': '49152', 'city': 'Bad Essen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 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