Information:
Fel:
ID
16868
Beskrivning
Study Sponsor: Astellas Study Title Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0002 Trial Registry Identification Number(#'s) NCT01416116 EudraCT Number: 2010-023258-34 Medical Condition Neuropathic pain Phase Phase 4 http://clinicaltrials.gov/show/NCT01416116 Treatment Visit Form 1/5: Date of Visit Inclusion Criteria Exclusion Criteria
Länk
http://clinicaltrials.gov/show/NCT01416116
Nyckelord
Versioner (2)
- 2016-07-23 2016-07-23 -
- 2016-08-11 2016-08-11 -
Uppladdad den
11 augusti 2016
DOI
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Licens
Creative Commons BY 4.0
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Treatment Visit Form 1/5 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116
Treatment Visit Form 1/5 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116
Similar models
Treatment Visit Form 1/5 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Date of Visit
Item
Date of Visit
date
CL Item
INCLUSION (1 )
CL Item
EXCLUSION (2 )
Item
Is the subject fully eligible per the Inclusion Criteria?
integer
C1512693 (UMLS CUI [1])
CL Item
No (0 )
CL Item
Yes (1 )
CL Item
1. Male or female between 18 and 90 years of age, inclusive. (IN01 )
CL Item
2. In good health as determined by the investigator. (IN02 )
CL Item
3. Documented diagnosis at the Treatment Visit of either: 1) PHN with pain persisting at least 3 months since shingles vesicle crusting, or 2) Neuropathic pain due to peripheral nerve injury including post-surgical neuropathic pain syndrome, persisting for a minimum of 3 months following the event. (IN03 )
CL Item
4. NPRS score => 4 for average pain both at the Screening Visit and at the Treatment Visit. (IN04 )
CL Item
5. Intact, non-irritated dry skin over the painful area(s) to be treated. (IN05 )
CL Item
6. Females of child bearing potential must be willing to use effective methods of birth control during the study and for 30 days following study termination. (IN06 )
CL Item
7. Willing and able to comply with protocol requirements for the duration of study participation. (IN07 )
CL Item
8. Written informed consent has been obtained. (IN08 )
CL Item
INCLUSION (1)
CL Item
EXCLUSION (2)
Item
Is the subject fully eligible per the Exclusion Criteria?
integer
C0680251 (UMLS CUI [1])
CL Item
No (0)
CL Item
Yes (1)
CL Item
1. Significant ongoing or recurrent pain of aetiology other than PHN or peripheral nerve injury, for example; compression-related neuropathies (e.g. spinal stenosis), mixed pain, fibromyalgia or arthritis. (EX01 )
CL Item
2. Pain due to Complex Regional Pain Syndrome (CRPS, Type I). (EX02 )
CL Item
3. Neuropathic pain areas located only on the face, above the hairline of the scalp, on the feet, and/or in proximity to mucous membranes. (EX03 )
CL Item
4. Past or current history if Type 1 or Type 2 diabetes mellitus. (EX04 )
CL Item
6. Clinically significant cardiovascular disease within 6 months prior to the Treatment Visit defined as cerebrovascular accident, unstable or poorly controlled hypertension, transient ischemic attack, myocardial infarction, unstable angina, current arrhythmia, any heart including coronary artery bypass graft surgery, percutaneous coronary angioplasty/stent placement, or valvular heart disease.=coronary artery bypass graft surgery, percutaneous coronary angioplasty/stent placement, or valvular heart disease. (EX06 )
CL Item
7. Clinically significant abnormal ECG at screening. (EX07 )
CL Item
8. Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete study or the evaluation of AEs. (EX08 )
CL Item
9. Uncontrolled epilepsy or risk of convulsions. (EX09 )
CL Item
10. Diagnosis of any major psychiatric disorder. (EX10 )
CL Item
11. Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete study evaluations and recall pain levels in the past 24 hours. (EX11 )
CL Item
12. Planned elective surgery during the trial. (EX12 )
CL Item
13. Any prior treatment with QUTENZA patches, including blinded patches administered as part of a clinical trial. (EX13 )
CL Item
14. Hypersensitivi ty to capsaicin (i.e. chilli peppers or over-the-count er [OTC] capsaicin products), any QUTENZA excipients or adhesives, local anesthetics, tramadol, or any tramadol excipients. (EX14 )
CL Item
16. Unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-asso ciated discomfort with oral or parental opioids, as judged by the investigator. (EX16 )
CL Item
17. Treatment with carbamazepine or MAO-inhibitors at the Treatment Visit. (EX17 )
CL Item
18. Use of any topical pain medication, such as non-steroidal anti-inflammat ory drugs, menthol, methyl salicylate, local anesthetics (including patch containing lidocaine), steroids or capsaicin products on the painful areas within 7 days preceding the Treatment Visit. (EX18 )
CL Item
19. Participation in any other clinical study or receipt of an investigational drug within 30 days prior to Screening Visit.=in any other clinical study or receipt of an investigational drug within 30 days prior to Screening Visit. (EX19 )
CL Item
20. Active substance abuse or history of chronic substance abuse within 1 year prior to the Screening Visit; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator. (EX20 )
CL Item
21. Subject, who in the opinion of the investigator is not likely to complete the study for any reason. (EX21 )
CL Item
5. Active malignacy or treatment for malignancy within a year prior to the Treatment Visit (including radiotherapy, chemotherapy and biologic or hormonal therapies). A history of squamous cell carcinoma or basal cell carcinoma not involving the area to be treated is allowed. (EX05 )
CL Item
15. Treatment with opioids (including tramadol) within 7 days preceding the Treatment Visit. (EX15 )