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

- 3/13/19 - 1 form, 14 itemgroups, 93 items, 2 languages
Itemgroups: 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 - Visit 2

- 3/12/19 - 1 form, 11 itemgroups, 44 items, 1 language
Itemgroups: 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

- 3/12/19 - 1 form, 11 itemgroups, 44 items, 1 language
Itemgroups: 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

- 3/12/19 - 1 form, 11 itemgroups, 47 items, 1 language
Itemgroups: 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 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

- 8/21/16 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: 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

- 8/21/16 - 1 form, 1 itemgroup, 26 items, 1 language
Itemgroup: 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

- 8/21/16 - 1 form, 1 itemgroup, 6 items, 1 language
Itemgroup: 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

Treatment Visit Form 5/5 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 5/5 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

- 8/11/16 - 1 form, 6 itemgroups, 24 items, 1 language
Itemgroups: NPRS 'pain now' score: 75 mins prior to patch, NPRS 'pain now' score: 40, 15 mins prior to patch, NPRS 'pain now' score: Post patch application and post patch removal, Tolerability score: Post patch removal, NPRS 'average pain' score: Day 1-3, Form: NPRS 'pain now' score: Day 1-3
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: NPRS 'pain now' score: 75 mins prior to patch NPRS 'pain now' score: 40, 15 mins prior to patch NPRS 'pain now' score: Post patch application and post patch removal Tolerability score: Post patch removal NPRS 'average pain' score: Day 1-3 NPRS 'pain now' score: Day 1-3

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