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A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets

Primary Purpose

Involutional Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
NE-58095 IR
NE-58095 IR Placebo
NE-58095 DR
NE-58095 DR Placebo
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Involutional Osteoporosis focused on measuring Drug Therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with a diagnosis of involutional osteoporosis
  2. Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent
  3. Women for whom at least 2 years have passed since the last natural menstruation

Exclusion Criteria:

  1. Patients with secondary osteoporosis
  2. Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass
  3. Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA)
  4. Patients with a history of radiotherapy to the lumbar spine or the pelvis
  5. Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period
  6. Patients with a history of treatment with any anti-receptor activator of nuclear factor-κB ligand (RANKL) monoclonal antibodies or parathyroid hormone products within 1 year before the start of the treatment period
  7. Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period
  8. Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period
  9. Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding
  10. Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus)
  11. Patients with hypocalcemia
  12. Patients with hypercalcemia
  13. Patients with a diagnosis of renal calculus
  14. Patients with serious renal, hepatic, or cardiac disease
  15. Patients who have received surgical dental procedures, such as a tooth extraction (including dental implant treatment), but whose dental problems remain unresolved at the start of the treatment period.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

NE-58095 IR 2.5 mg Once Daily on Awakening

NE-58095 DR 25 mg Once Monthly on Awakening

NE-58095 DR 25 mg Once Monthly Following Breakfast

NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast

NE-58095 DR 37.5 mg Once Monthly on Awakening

NE-58095 DR 37.5 mg Once Monthly Following Breakfast

NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast

Arm Description

NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.

NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.

NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.

NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.

NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.

NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.

NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study
The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.

Secondary Outcome Measures

Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Urine samples for urine bone turnover markers were collected at specified visits according to the study schedule. Urine samples were to be collected at about the same time of the day, as far as possible, throughout the study. Urine NTX was corrected by creatinine value.
Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)
New non-traumatic vertebral fractures were identified by interpretable X-ray images of 13 vertebrae from the fourth thoracic to the fourth lumbar vertebra. A Central Review Committee member for X-ray determined the presence or absence of new vertebral fractures, the number of new fractures, the presence or absence of worsening pre-existing vertebral fractures, and the number of worsened fractures. The assessment of new vertebral fractures and the worsening of pre-existing vertebral fractures was semiquantitative. The X-ray images were visually inspected and classified into normal (Grade 0), mild deformation (Grade 1), moderate deformation (Grade 2), or severe deformation (Grade 3). If the assessment of any vertebra became worse by at least 1 grade after starting the treatment, its height was measured. A new vertebral fracture or a worsening pre-existing vertebral fracture was concluded if the vertebra's height was reduced from the baseline by at least 20% and by at least 4 mm.

Full Information

First Posted
February 12, 2014
Last Updated
February 7, 2017
Sponsor
Takeda
Collaborators
EA Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02063854
Brief Title
A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
Official Title
A Phase 2/3, Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Once-monthly Oral Administration of NE-58095DR Tablet (25 mg or 37.5 mg) Versus Once-daily Oral Administration of NE-58095IR Tablet (2.5 mg) for the Treatment of Involutional Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
EA Pharma Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12 months in participants with involutional osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5 mg tablets once daily for 12 months are set as the control group.
Detailed Description
The primary objective of the present study is to verify the non-inferiority of once-monthly oral administration of NE-58095 DR tablets for 12 months to once-daily oral administration of NE-58095 IR 2.5 mg tablets for 12 months, in terms of efficacy in participants with involutional osteoporosis. Secondary objectives of the present study are as follows: to compare the safety of once-monthly oral administration of NE-58095 DR tablets for 12 months with the safety of once-daily oral administration of NE-58095 IR tablets (at 2.5 mg) for 12 months in participants with involutional osteoporosis at time of wakening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Involutional Osteoporosis
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
871 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NE-58095 IR 2.5 mg Once Daily on Awakening
Arm Type
Active Comparator
Arm Description
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Arm Title
NE-58095 DR 25 mg Once Monthly on Awakening
Arm Type
Experimental
Arm Description
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Arm Title
NE-58095 DR 25 mg Once Monthly Following Breakfast
Arm Type
Experimental
Arm Description
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Arm Title
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
Arm Type
Experimental
Arm Description
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Arm Title
NE-58095 DR 37.5 mg Once Monthly on Awakening
Arm Type
Experimental
Arm Description
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Arm Title
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
Arm Type
Experimental
Arm Description
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Arm Title
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
Arm Type
Experimental
Arm Description
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Intervention Type
Drug
Intervention Name(s)
NE-58095 IR
Intervention Description
NE-58095 IR tablets
Intervention Type
Drug
Intervention Name(s)
NE-58095 IR Placebo
Intervention Description
NE-58095 IR placebo-matching tablets
Intervention Type
Drug
Intervention Name(s)
NE-58095 DR
Intervention Description
NE-58095 DR tablets
Intervention Type
Drug
Intervention Name(s)
NE-58095 DR Placebo
Intervention Description
NE-58095 DR placebo-matching tablets
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study
Description
The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.
Time Frame
Baseline and End of Study (up to Month 12)
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
Description
The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Time Frame
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Title
Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
Description
The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Time Frame
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Title
Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
Description
The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Time Frame
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Title
Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
Description
The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Time Frame
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Title
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Description
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Title
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Description
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Title
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Description
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Title
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Description
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Title
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Description
Urine samples for urine bone turnover markers were collected at specified visits according to the study schedule. Urine samples were to be collected at about the same time of the day, as far as possible, throughout the study. Urine NTX was corrected by creatinine value.
Time Frame
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Title
Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)
Description
New non-traumatic vertebral fractures were identified by interpretable X-ray images of 13 vertebrae from the fourth thoracic to the fourth lumbar vertebra. A Central Review Committee member for X-ray determined the presence or absence of new vertebral fractures, the number of new fractures, the presence or absence of worsening pre-existing vertebral fractures, and the number of worsened fractures. The assessment of new vertebral fractures and the worsening of pre-existing vertebral fractures was semiquantitative. The X-ray images were visually inspected and classified into normal (Grade 0), mild deformation (Grade 1), moderate deformation (Grade 2), or severe deformation (Grade 3). If the assessment of any vertebra became worse by at least 1 grade after starting the treatment, its height was measured. A new vertebral fracture or a worsening pre-existing vertebral fracture was concluded if the vertebra's height was reduced from the baseline by at least 20% and by at least 4 mm.
Time Frame
Baseline to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of involutional osteoporosis Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent Women for whom at least 2 years have passed since the last natural menstruation Exclusion Criteria: Patients with secondary osteoporosis Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA) Patients with a history of radiotherapy to the lumbar spine or the pelvis Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period Patients with a history of treatment with any anti-receptor activator of nuclear factor-κB ligand (RANKL) monoclonal antibodies or parathyroid hormone products within 1 year before the start of the treatment period Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus) Patients with hypocalcemia Patients with hypercalcemia Patients with a diagnosis of renal calculus Patients with serious renal, hepatic, or cardiac disease Patients who have received surgical dental procedures, such as a tooth extraction (including dental implant treatment), but whose dental problems remain unresolved at the start of the treatment period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Nagoya-shi
State/Province
Aichi
Country
Japan
City
Chiba-shi
State/Province
Chiba
Country
Japan
City
Narashino-shi
State/Province
Chiba
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
City
Onga-gun
State/Province
Fukuoka
Country
Japan
City
Ebetsu-shi
State/Province
Hokkaido
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Kako-gun
State/Province
Hyogo
Country
Japan
City
Morioka-shi
State/Province
Iwate
Country
Japan
City
Atsugi-shi
State/Province
Kanagawa
Country
Japan
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
City
Zushi-shi
State/Province
Kanagawa
Country
Japan
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
City
Tamana-shi
State/Province
Kumamoto
Country
Japan
City
Sendai-shi
State/Province
Miyagi
Country
Japan
City
Tagajo-shi
State/Province
Miyagi
Country
Japan
City
Miyazaki-shi
State/Province
Miyazaki
Country
Japan
City
Saito-shi
State/Province
Miyazaki
Country
Japan
City
Higashi Osaka-shi
State/Province
Osaka
Country
Japan
City
Saitama-shi
State/Province
Saitama
Country
Japan
City
Daito-ku
State/Province
Tokyo
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
City
Wakayama-shi
State/Province
Wakayama
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets

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