Diabetic NeuropathiesPhase 2NCT00508430
ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy
A Phase 2 study testing ASP8825 in people with Diabetic Neuropathies, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- ASP8825
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 8 sitesJapan
- Study dates
- Jul 2007to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 20 - 79 years
- Diabetes mellitus patients with diabetic polyneuropathy who have pain symptom for 26 weeks prior to the study
- Subjects who are compliant with diary completion
Who cannot join
- Subjects who have pain from other diseases at the evaluating site
- Subjects who have nerve diseases at the evaluating site
- Subjects with foot ulcer or gangrene
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kanto
Study site
Kyusyu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: ASP 8825 Phase II Study-A Double- Blind, Placebo- Controlled Study in Patients With Painful Diabetic Polyneuropathy
To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.
Read the detailed description
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with painful diabetic polyneuropathy.
- Conditions
- Diabetic Neuropathies
- Being tested
- ASP8825, Placebo
- Keywords
- ASP8825, Diabetic Neuropathies, Pain
- Medical subject headings
- Diabetic Neuropathies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP8825Drug
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low dose group Receives: Drug: ASP8825 |
| 2 | Experimental | Middle dose group Receives: Drug: ASP8825 |
| 3 | Experimental | High dose group Receives: Drug: ASP8825 |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity rating
Measured: 8 week
Secondary outcomes (4)
Severity of numbness, maximum pain, night pain and sleep disturbance.
Measured: 8 week
Responder rate
Measured: 8 week
Patient's global impression of change
Measured: 8 week
Clinical's global impression of change
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: An independent DMC determined continuation was unlikely to demonstrate a statistically significant advantage of ASP8825 over placebo on the primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- 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
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508430
- Sponsor's protocol ID
- 8825-CL-0007
- Status last verified
- Dec 2008
- First submitted
- 26 Jul 2007
- Last updated
- 5 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP 8825 Phase II Study-A Double- Blind, Placebo- Controlled Study in Patients With Painful Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT00508430
- Acronym / sponsor ID
- 8825-CL-0007
- Conditions
- Diabetic Neuropathies
- Keywords
- ASP8825, Diabetic Neuropathies, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An independent DMC determined continuation was unlikely to demonstrate a statistically significant advantage of ASP8825 over placebo on the primary endpoint
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.
Detailed description
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with painful diabetic polyneuropathy.
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 | Experimental | Drug: ASP8825Low dose group |
| 2 | Experimental | Drug: ASP8825Middle dose group |
| 3 | Experimental | Drug: ASP8825High dose group |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged 20 - 79 years
- Diabetes mellitus patients with diabetic polyneuropathy who have pain symptom for 26 weeks prior to the study
- Subjects who are compliant with diary completion
Key exclusion criteria (3 listed)
- Subjects who have pain from other diseases at the evaluating site
- Subjects who have nerve diseases at the evaluating site
- Subjects with foot ulcer or gangrene
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 |
|---|---|---|
| ASP8825oral | Drug | 1, 2, 3 |
| Placebooral | Drug | 4 |
Primary outcome
Pain severity rating
Time frame: 8 week
4 secondary outcomes
Severity of numbness, maximum pain, night pain and sleep disturbance.
Time frame: 8 week
Responder rate
Time frame: 8 week
Patient's global impression of change
Time frame: 8 week
Clinical's global impression of change
Time frame: 8 week
Results and safety
The study was stopped early (reason given: An independent DMC determined continuation was unlikely to demonstrate a statistically significant advantage of ASP8825 over placebo on the primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2008.
Related trials for Diabetic Neuropathies
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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Central Contact study chair
Astellas Pharma Inc
8 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 ASP8825 in people with Diabetic Neuropathies, run by Astellas Pharma Inc at 8 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study was stopped early (reason given: An independent DMC determined continuation was unlikely to demonstrate a statistically significant advantage of ASP8825 over placebo on the primary endpoint). Results are not available in the source record.
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 severity rating (time frame: 8 week). 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 5 Dec 2008.