Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
| |
| 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-249 | Drug | 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain (Subjective Symptom) | Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline. Regarding VAS (dotted onto a 100 mm line), 0 mm means "No Pain" and 100 mm means "Worst Pain Imaginable". | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement Rate of Pain (Doctor's Judgment) | Percentage of participants qualified for improvement of pain by doctor's judgement. Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend. Improvement defind by "stopped or almost stopped" or "alleviated". | Baseline and Week 4 |
Not provided
Inclusion Criteria:
Patients who fulfill all of the following items
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katsuhisa Saito | Division of New Product Evaluation and Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo of OPC-249/vial |
| FG001 | OPC-249 (30IU) | 30 IU of OPC-249/vial |
| FG002 | OPC-249 (60IU) | 60 IU of OPC-249/vial |
| FG003 | OPC-249 (120IU) | 120 IU of OPC-249/vial |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo of OPC-249/vial |
| BG001 | OPC-249 (30IU) | 30 IU of OPC-249/vial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain (Subjective Symptom) | Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline. Regarding VAS (dotted onto a 100 mm line), 0 mm means "No Pain" and 100 mm means "Worst Pain Imaginable". | Posted | Mean | Standard Deviation | mm | Baseline and Week 4 |
|
4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo of OPC-249/vial |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| IMAOKA, Kyoji, Operatin Officer, Gemeral Manager | Headwuarters of New Product Evaluation and Development, Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7366 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Hokkaido Region |
| Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 |
| OPC-249 (60IU) |
60 IU of OPC-249/vial |
| BG003 | OPC-249 (120IU) | 120 IU of OPC-249/vial |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | OPC-249 (120IU) | 120 IU of OPC-249 /vial |
|
|
| Secondary | Improvement Rate of Pain (Doctor's Judgment) | Percentage of participants qualified for improvement of pain by doctor's judgement. Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend. Improvement defind by "stopped or almost stopped" or "alleviated". | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and Week 4 |
|
|
|
| 0 |
| 32 |
| 9 |
| 32 |
| EG001 | OPC-249 (30IU) | 30 IU of OPC-249/vial | 1 | 23 | 9 | 23 |
| EG002 | OPC-249 (60IU) | 60 IU of OPC-249/vial | 0 | 22 | 6 | 22 |
| EG003 | OPC-249 (120IU) | 120 IU of OPC-249/vial | 0 | 24 | 4 | 24 |
| Disorder gastrointestinal | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Surfactant protein increase | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Blood pressure rise | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Limbs pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
Not provided
Not provided