Trial Outcomes & Findings for Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis (NCT NCT00504426)
NCT ID: NCT00504426
Last Updated: 2014-01-30
Results Overview
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".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2014-01-30
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo of OPC-249/vial
|
OPC-249 (30IU)
30 IU of OPC-249/vial
|
OPC-249 (60IU)
60 IU of OPC-249/vial
|
OPC-249 (120IU)
120 IU of OPC-249/vial
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
23
|
22
|
24
|
|
Overall Study
COMPLETED
|
29
|
22
|
18
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
4
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo of OPC-249/vial
|
OPC-249 (30IU)
30 IU of OPC-249/vial
|
OPC-249 (60IU)
60 IU of OPC-249/vial
|
OPC-249 (120IU)
120 IU of OPC-249/vial
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
Baseline characteristics by cohort
| Measure |
Placebo
n=32 Participants
Placebo of OPC-249/vial
|
OPC-249 (30IU)
n=23 Participants
30 IU of OPC-249/vial
|
OPC-249 (60IU)
n=22 Participants
60 IU of OPC-249/vial
|
OPC-249 (120IU)
n=24 Participants
120 IU of OPC-249/vial
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
73.0 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
73.4 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
72.3 years
STANDARD_DEVIATION 5.9 • n=4 Participants
|
72.6 years
STANDARD_DEVIATION 5.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
32 participants
n=5 Participants
|
23 participants
n=7 Participants
|
22 participants
n=5 Participants
|
24 participants
n=4 Participants
|
101 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Change 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".
Outcome measures
| Measure |
Placebo
n=29 Participants
Placebo of OPC-249/vial
|
OPC-249 (30IU)
n=22 Participants
30 IU of OPC-249 /vial
|
OPC-249 (60IU)
n=18 Participants
60 IU of OPC-249 /vial
|
OPC-249 (120IU)
n=24 Participants
120 IU of OPC-249 /vial
|
|---|---|---|---|---|
|
Pain (Subjective Symptom)
|
-37.8 mm
Standard Deviation 28.7
|
-24.5 mm
Standard Deviation 27.3
|
-40.5 mm
Standard Deviation 26.2
|
-29.0 mm
Standard Deviation 23.7
|
SECONDARY outcome
Timeframe: Baseline and Week 4Percentage 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".
Outcome measures
| Measure |
Placebo
n=29 Participants
Placebo of OPC-249/vial
|
OPC-249 (30IU)
n=22 Participants
30 IU of OPC-249 /vial
|
OPC-249 (60IU)
n=18 Participants
60 IU of OPC-249 /vial
|
OPC-249 (120IU)
n=24 Participants
120 IU of OPC-249 /vial
|
|---|---|---|---|---|
|
Improvement Rate of Pain (Doctor's Judgment)
|
69.0 Percentage of Participants
Interval 49.2 to 84.7
|
59.1 Percentage of Participants
Interval 36.4 to 79.3
|
77.8 Percentage of Participants
Interval 52.4 to 93.6
|
66.7 Percentage of Participants
Interval 44.7 to 84.4
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
OPC-249 (30IU)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
OPC-249 (60IU)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
OPC-249 (120IU)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=32 participants at risk
Placebo of OPC-249/vial
|
OPC-249 (30IU)
n=23 participants at risk
30 IU of OPC-249/vial
|
OPC-249 (60IU)
n=22 participants at risk
60 IU of OPC-249/vial
|
OPC-249 (120IU)
n=24 participants at risk
120 IU of OPC-249/vial
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/32 • 4 weeks
|
4.3%
1/23 • Number of events 1 • 4 weeks
|
0.00%
0/22 • 4 weeks
|
0.00%
0/24 • 4 weeks
|
Other adverse events
| Measure |
Placebo
n=32 participants at risk
Placebo of OPC-249/vial
|
OPC-249 (30IU)
n=23 participants at risk
30 IU of OPC-249/vial
|
OPC-249 (60IU)
n=22 participants at risk
60 IU of OPC-249/vial
|
OPC-249 (120IU)
n=24 participants at risk
120 IU of OPC-249/vial
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • Number of events 2 • 4 weeks
|
0.00%
0/23 • 4 weeks
|
0.00%
0/22 • 4 weeks
|
0.00%
0/24 • 4 weeks
|
|
Gastrointestinal disorders
Disorder gastrointestinal
|
0.00%
0/32 • 4 weeks
|
0.00%
0/23 • 4 weeks
|
9.1%
2/22 • Number of events 2 • 4 weeks
|
0.00%
0/24 • 4 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
2/32 • Number of events 2 • 4 weeks
|
13.0%
3/23 • Number of events 3 • 4 weeks
|
0.00%
0/22 • 4 weeks
|
0.00%
0/24 • 4 weeks
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
6.2%
2/32 • Number of events 2 • 4 weeks
|
0.00%
0/23 • 4 weeks
|
4.5%
1/22 • Number of events 1 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
|
Investigations
Surfactant protein increase
|
9.4%
3/32 • Number of events 3 • 4 weeks
|
17.4%
4/23 • Number of events 4 • 4 weeks
|
13.6%
3/22 • Number of events 3 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
|
Investigations
Blood pressure rise
|
6.2%
2/32 • Number of events 2 • 4 weeks
|
0.00%
0/23 • 4 weeks
|
4.5%
1/22 • Number of events 1 • 4 weeks
|
0.00%
0/24 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Limbs pain
|
0.00%
0/32 • 4 weeks
|
8.7%
2/23 • Number of events 2 • 4 weeks
|
0.00%
0/22 • 4 weeks
|
0.00%
0/24 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32 • 4 weeks
|
4.3%
1/23 • Number of events 1 • 4 weeks
|
0.00%
0/22 • 4 weeks
|
8.3%
2/24 • Number of events 2 • 4 weeks
|
Additional Information
IMAOKA, Kyoji, Operatin Officer, Gemeral Manager
Headwuarters of New Product Evaluation and Development, Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place