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Unscheduled Visit >> Unscheduled Event Form 1/2 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

- 17.09.21 - 1 Formular, 7 Itemgruppen, 22 Datenelemente, 1 Sprache
Itemgruppen: Physical Examination, Vital Signs, ECG: 12 Lead ECG, Laboratory Tests: Hematology, Abnormal Lab tests: Hematology, Laboratory Tests: Biochemistry, Abnormal Lab tests: Biochemistry
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 Unscheduled Visit >> Unscheduled Event Physical Examination Vital Signs 12 Lead ECG Laboratory Tests: Hematology

Unscheduled Visit >> Unscheduled Event Form 2/2 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

- 17.09.21 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Pregnancy Test, Unscheduled Event
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 Unscheduled Visit >> Unscheduled Event Form Pregnancy Test Unscheduled Event

Screening Visit Form 2/4 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

- 17.09.21 - 1 Formular, 6 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Primary Diagnosis: Old diagnosis fields, Primary Diagnosis: New diagnosis fields, Physical Examination, Vital Signs, Height and Weight, ECG: 12 Lead ECG
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 Screening Visit Form 2/4: Primary Diagnosis Physical Examination Vital Signs Height and Weight ECG: 12 Lead ECG

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Period 1

- 13.03.19 - 1 Formular, 14 Itemgruppen, 93 Datenelemente, 2 Sprachen
Itemgruppen: Administrative data, Vital Signs Pre-Challenge, Randomisation Number, Investigational Product (Dose), Vital Signs (Dosing), Temperature (Dosing), Hematology (Dosing), Clinical Chemistry, Electrocardiogram, Peak Nasal Inspiratory Flow Rate, Total Symptom Score, Visual Analogue Scale, Nostril Secretions, Pharmacokinetics - Blood
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Screening 2

- 12.03.19 - 1 Formular, 13 Itemgruppen, 50 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Placebo, Capsaicin challenge - Challenge 1, Capsaicin challenge - Challenge 2, Capsaicin challenge - Challenge 3, Peak Nasal Inspiratory Flow Rate, Total Symptom Score, Visual Analogue Scale, Nostril Secretions, Nostril Secretions - Tissue Weights Only, Nostril Secretions, Vital Signs Pre-Challenge, Randomisation Number
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Visit 2

- 12.03.19 - 1 Formular, 11 Itemgruppen, 44 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Placebo, Capsaicin challenge - Challenge 1, Capsaicin challenge - Challenge 2, Capsaicin challenge - Challenge 3, Peak Nasal Inspiratory Flow Rate, Total Symptom Score, Visual Analogue Scale, Nostril Secretions, Nostril Secretions - Tissue Weights Only, Nostril Secretions
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Visit 3

- 12.03.19 - 1 Formular, 11 Itemgruppen, 44 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Placebo, Capsaicin challenge - Challenge 1, Capsaicin challenge - Challenge 2, Capsaicin challenge - Challenge 3, Peak Nasal Inspiratory Flow Rate, Total Symptom Score, Visual Analogue Scale, Nostril Secretions, Nostril Secretions - Tissue Weights Only, Nostril Secretions
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Visit 1

- 12.03.19 - 1 Formular, 11 Itemgruppen, 47 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Placebo, Capsaicin challenge - Challenge 1, Capsaicin challenge - Challenge 2, Capsaicin challenge - Challenge 3, Peak Nasal Inspiratory Flow Rate, Total Symptom Score, Visual Analogue Scale, Nostril Secretions, Nostril Secretions - Tissue Weights Only, Nostril Secretions
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

Cumulative Form 3/3 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

- 21.08.16 - 1 Formular, 1 Itemgruppe, 7 Datenelemente, 1 Sprache
Itemgruppe: Non-medication Therapy
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 Cumulative Form 2/2 Non-medication Therapy

Cumulative Form 2/3 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

- 21.08.16 - 1 Formular, 1 Itemgruppe, 14 Datenelemente, 1 Sprache
Itemgruppe: Previous and/or Concomitant Medication
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 Cumulative: Previous and/or Concomitant Medication

Cumulative Form 1/3 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 - Cumulative Form 1/3 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

- 21.08.16 - 1 Formular, 1 Itemgruppe, 26 Datenelemente, 1 Sprache
Itemgruppe: Adverse Event 2
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 Cumulative Adverse Event 2

End of Study Form 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 - End of Study Form 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

- 21.08.16 - 1 Formular, 1 Itemgruppe, 6 Datenelemente, 1 Sprache
Itemgruppe: End of Study
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 End of Study End of Study

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