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

NCT ID: NCT02063854

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 871 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-11-30

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.

Conditions

Involutional Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NE-58095 IR 2.5 mg Once Daily on Awakening

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.

Group Type: ACTIVE_COMPARATOR

NE-58095 IR

Intervention Type: DRUG

NE-58095 IR tablets

NE-58095 DR Placebo

Intervention Type: DRUG

NE-58095 DR placebo-matching tablets

NE-58095 DR 25 mg Once Monthly on Awakening

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.

Group Type: EXPERIMENTAL

NE-58095 IR Placebo

Intervention Type: DRUG

NE-58095 IR placebo-matching tablets

NE-58095 DR

Intervention Type: DRUG

NE-58095 DR tablets

NE-58095 DR Placebo

Intervention Type: DRUG

NE-58095 DR placebo-matching tablets

NE-58095 DR 25 mg Once Monthly Following Breakfast

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.

Group Type: EXPERIMENTAL

NE-58095 IR Placebo

Intervention Type: DRUG

NE-58095 IR placebo-matching tablets

NE-58095 DR

Intervention Type: DRUG

NE-58095 DR tablets

NE-58095 DR Placebo

Intervention Type: DRUG

NE-58095 DR placebo-matching tablets

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

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.

Group Type: EXPERIMENTAL

NE-58095 IR Placebo

Intervention Type: DRUG

NE-58095 IR placebo-matching tablets

NE-58095 DR

Intervention Type: DRUG

NE-58095 DR tablets

NE-58095 DR Placebo

Intervention Type: DRUG

NE-58095 DR placebo-matching tablets

NE-58095 DR 37.5 mg Once Monthly on Awakening

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.

Group Type: EXPERIMENTAL

NE-58095 IR Placebo

Intervention Type: DRUG

NE-58095 IR placebo-matching tablets

NE-58095 DR

Intervention Type: DRUG

NE-58095 DR tablets

NE-58095 DR Placebo

Intervention Type: DRUG

NE-58095 DR placebo-matching tablets

NE-58095 DR 37.5 mg Once Monthly Following Breakfast

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.

Group Type: EXPERIMENTAL

NE-58095 IR Placebo

Intervention Type: DRUG

NE-58095 IR placebo-matching tablets

NE-58095 DR

Intervention Type: DRUG

NE-58095 DR tablets

NE-58095 DR Placebo

Intervention Type: DRUG

NE-58095 DR placebo-matching tablets

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

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.

Group Type: EXPERIMENTAL

NE-58095 IR Placebo

Intervention Type: DRUG

NE-58095 IR placebo-matching tablets

NE-58095 DR

Intervention Type: DRUG

NE-58095 DR tablets

NE-58095 DR Placebo

Intervention Type: DRUG

NE-58095 DR placebo-matching tablets

Interventions

NE-58095 IR

NE-58095 IR tablets

Intervention Type: DRUG

NE-58095 IR Placebo

NE-58095 IR placebo-matching tablets

Intervention Type: DRUG

NE-58095 DR

NE-58095 DR tablets

Intervention Type: DRUG

NE-58095 DR Placebo

NE-58095 DR placebo-matching tablets

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EA Pharma Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Nagoya, Aichi-ken, Japan

Chiba, Chiba, Japan

Narashino-shi, Chiba, Japan

Fukuoka, Fukuoka, Japan

Kitakyushu-shi, Fukuoka, Japan

Onga-gun, Fukuoka, Japan

Ebetsu-shi, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Kako-gun, Hyōgo, Japan

Morioka, Iwate, Japan

Atsugi-shi, Kanagawa, Japan

Kawasaki-shi, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Zushi-shi, Kanagawa, Japan

Kumamoto, Kumamoto, Japan

Tamana-shi, Kumamoto, Japan

Sendai, Miyagi, Japan

Tagajō-shi, Miyagi, Japan

Miyazaki, Miyazaki, Japan

Saito-shi, Miyazaki, Japan

Higashi Osaka-shi, Osaka, Japan

Saitama-shi, Saitama, Japan

Daito-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Wakayama, Wakayama, Japan

Countries

Japan

Other Identifiers

JapicCTI-142440

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1153-0440

Identifier Type: REGISTRY

Identifier Source: secondary_id

NE-58095DR/CCT-401

Identifier Type: OTHER

Identifier Source: secondary_id

CCT-401

Identifier Type: -

Identifier Source: org_study_id

NCT02066376

Identifier Type: -

Identifier Source: nct_alias