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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1

Placebo patch was applied for 30 minutes to the painful area(s) on Day 1

Redacted CSRs e05-cl-3004-clrrs.pdf

e05-cl-3004-clls-disc01-en-final-02.pdf

The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.

A study to evaluate efficacy and safety of a single application of Capsaicin 8%transdermal delivery system compared to placebo in reducing pain intensity in subjects with Painful Diabetic Peripheral Neuropathy (PDPN)

Participants were divided into 2 groups of approximately equal size. In the first group, participants received a Capsaicin 8% patch applied for 30 minutes to the feet; in the second group, participants received a placebo patch applied for 30 minutes to the feet. Participants were involved in the study for approximately 12 weeks and have visited the clinic approximately 6 times.

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Therapeutic Area

Link to results on Astellas Clinical Study Results Web site

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A phase III, double-blind, randomized, placebo-controlled, multicenter study evaluating the efficacy and safety of QUTENZA® in subjects with Painful Diabetic Peripheral Neuropathy

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

Duration of Painful Diabetic Peripheral Neuropathy (PDPN)

Study Specific Characteristic

Glycosylated Hemoglobin (HbA1c)

Average pain was assessed by the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN) on a numeric rating scale from 0 - 10, with 0 describing “no pain” and 10 describing severe pain listed as “pain as bad as you can imagine”.

Average Pain Score

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).

All statistical comparisons were made using two-sided tests at the 5% significance level

Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.

Percent change in the average daily pain score from Baseline to between Weeks 2 and 8

Percent Change in the Average Daily Pain Score from baseline to between Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).

All statistical comparisons were made using two-sided tests at the 5% significance level.

Percent change in the average daily pain score from baseline to between Weeks 2 and 12

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

Week 9

Week 10

Week 11

Week 12

Weekly Percent Change from baseline in average daily pain score from baseline to Week 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).

Comparison of capsaicin 8% and placebo for change from Baseline to Week 2.

Comparison of capsaicin 8% and placebo for change from Baseline to Week 3.

Comparison of capsaicin 8% and placebo for change from Baseline to Week 4.

Comparison of capsaicin 8% and placebo for change from Baseline to Week 5.

Comparison of capsaicin 8% and placebo for change from Baseline to Week 6.

Comparison of capsaicin 8% and placebo for change from Baseline to Week 7.

Comparison of capsaicin 8% and placebo for change from Baseline to Week 8.

Comparison of capsaicin 8% and placebo for change from Baseline to Week 9.

Comparison of capsaicin 8% and placebo for change from Baseline to Week 10.

Comparison of capsaicin 8% and placebo for change from Baseline to Week 11.

Comparison of capsaicin 8% and placebo for change from Baseline to Week 12.

Intention to Treat (ITT ); Baseline last observation carried forward (BLOCF) imputation was used.

Weekly Percent Change from baseline in average daily pain score

Baseline

Weekly average of average daily pain score at Baseline and Weeks 2,4,8 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).

Weekly average of Average daily pain at Baseline and every week after baseline

30% Pain Reduction-Week 2 to 8

30% Pain Reduction-Week 2 to 12

Percentage of participants achieving 30% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).

Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.

Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.

Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.

Percentage of participants with 30% reduction in average daily pain score.

50% Pain Reduction-Week 2 to 8

50% Pain Reduction-Week 2 to 12

Percentage of participants achieving 50% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).

Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.

Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.

Percentage of participants with 50% reduction in average daily pain score.

Very Much Improved

Much Improved

Minimally Improved

No Change

Minimally Worse

Much Worse

Very Much Worse

Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 2

Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.

Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire in Week 2

Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 8

Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire in Week 8

Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 12

Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire in Week 12

Week 8 [ N=180;N=170]

Week 12 [N=170; N=172]

Week 2 [N=184; N=181]

Change from Baseline in the European Quality Of Life (QOL) questionnaire in 5 dimensions (EQ-5D) with Visual Analog Scale (VAS) to Weeks 2, 8 and 12. EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0–100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL).

The statistical comparison between Baseline and Week 8 was made using two-sided tests at the 5% significance level.

The statistical comparison between Baseline and Week 12 was made using two-sided tests at the 5% significance level.

The statistical comparison between Baseline and Week 2 was made using two-sided tests at the 5% significance level.

Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.

Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12

Week 2 [N=183; N=180]

Week 8 [N=178; N=171]

Week 12 [N=169; N=169]

The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, that contain 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.

Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.

Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.

Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.

Change in Hospital Anxiety and Depression Scale (HADS) anxiety scale from Baseline to Weeks 2, 8 and 12

Week 2 [ N=184; N=181]

Week 8 [N=180; N=171]

Week 12 [N=169; N=171]

The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, it contains 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.

Change in Hospital Anxiety and Depression Scale (HADS) depression scale from Baseline to Weeks 2, 8 and 12.

Week 8 [N=177; N=170] [Not at all]

Week 8 [N=177; N=170] [Slightly Better]

Week 8 [N=177; N=170] [Moderately Better]

Week 8 [N=177; N=170] [Quite a Bit Better]

Treatment satisfaction assessment based on Self-Assessment Treatment (SAT II) questionnaire and the question "Over the past 7 days, how much has the study treatment improved your pain level?"