Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02063854 | A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets | PHASE2 | COMPLETED | 871 | — | — | Feb 1, 2014 | Nov 1, 2015 | Feb 23, 2017 | 25 | Japan |
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.
| Arm | Type | Description |
|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | ACTIVE_COMPARATOR | 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 Once Monthly on Awakening | EXPERIMENTAL | 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 Once Monthly Following Breakfast | EXPERIMENTAL | 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 Once Monthly 30 Min. After Breakfast | EXPERIMENTAL | 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 Once Monthly on Awakening | EXPERIMENTAL | 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 Once Monthly Following Breakfast | EXPERIMENTAL | 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 Once Monthly 30 Min. After Breakfast | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| NE-58095 IR | DRUG | NE-58095 IR tablets |
| NE-58095 IR Placebo | DRUG | NE-58095 IR placebo-matching tablets |
| NE-58095 DR | DRUG | NE-58095 DR tablets |
| NE-58095 DR Placebo | DRUG | NE-58095 DR placebo-matching tablets |
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 Cr...