Pain Due to OsteoporosisPhase 2NCT00504426
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
A Phase 2 study testing OPC-249 in people with Pain Due to Osteoporosis, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 46 to 79 years, women only
- Conditions the study is for
- Pain Due to Osteoporosis
- What is being tested?
- OPC-249
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 5 sitesJapan
- Study dates
- Jul 2007to May 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who fulfill all of the following items
- Patients with primary osteoporosis
- Patients who have existing 1-4 vertebral fractures
- Patients with back pain persisting for one week or more
- Postmenopausal women between 46 and less than 80 years of age
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Study site
Chubu Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
About this study
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.
- Conditions
- Pain Due to Osteoporosis
- Being tested
- OPC-249
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-249Drug
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: OPC-249 |
| 2 | Active comparator | Not described Receives: Drug: OPC-249 |
| 3 | Active comparator | Not described Receives: Drug: OPC-249 |
| 4 | Active comparator | Not described Receives: Drug: OPC-249 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Baseline and Week 4
Secondary outcomes (1)
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".
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain Due to OsteoporosisStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsuhisa Saito, Study director, Division of New Product Evaluation and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504426
- Sponsor's protocol ID
- 249-06-002OD
- Status last verified
- Dec 2013
- First submitted
- 16 Jul 2007
- Last updated
- 30 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
- ClinicalTrials.gov ID
- NCT00504426
- Acronym / sponsor ID
- 249-06-002OD
- Conditions
- Pain Due to Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Posted 30 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: OPC-249 |
| 2 | Active comparator | Drug: OPC-249 |
| 3 | Active comparator | Drug: OPC-249 |
| 4 | Active comparator | Drug: OPC-249 |
Who may qualify
- Ages
- 46 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who fulfill all of the following items
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPC-2491 pugh/day for 4 weeks (30 IU, 60IU, or 90IU) | Drug | 1, 2, 3, 4 |
Primary outcome
Pain (Subjective Symptom)
Time frame: Baseline and Week 4
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".
1 secondary outcome
Improvement Rate of Pain (Doctor's Judgment)
Time frame: Baseline and Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katsuhisa Saito study director
Division of New Product Evaluation and Development
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPC-249 in people with Pain Due to Osteoporosis, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (Subjective Symptom) (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2014.