Diabetic PolyneuropathyPhase 2NCT00307749
Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy
A Phase 2 study testing MCC-257 in people with Diabetic Polyneuropathy, run by Tanabe Pharma Corporation.
Trial summary
The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- MCC-257
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Aug 2007
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is male or female, 18-70 years of age
- The patient has either type 1 or type 2 diabetes
- The patient has mild to moderate diabetic neuropathy
- The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests
Who cannot join
- Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix
- BMI>40
- A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition
- Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function
- Women of childbearing potential who do not refrain from sexual activity or use adequate contraception
- Pregnant or lactating women
- An ALT or AST value >2X upper limit of normal (ULN)
- Clinically significant cardiovascular disease within the last six (6) months
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20mg, 40mg and 80mg of MCC-257 in Patients With Mild to Moderate Diabetic Polyneuropathy
The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy
Read the detailed description
The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- Placebo, MCC-257
- Keywords
- Neuropathy, Nerve Conduction
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
once daily for 24 weeks
MCC-257Drug
20mg, once daily for 24 weeks
MCC-257Drug
40mg, once daily for 24 weeks
MCC-257Drug
80mg, once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: MCC-257 |
| 3 | Experimental | Not described Receives: Drug: MCC-257 |
| 4 | Experimental | Not described Receives: Drug: MCC-257 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve Conduction Studies
Measured: Day 1, Week 24
Secondary outcomes (4)
Nerve fiber density
Measured: Day 1, Week 24
QST
Measured: Day 1, Week 12, Week 24
Symptom
Measured: Day 1, Week 12, Week 24
Clinical Global Impression
Measured: Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startMar 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Professor, Principal investigator, Information at Mitsubishi Pharma America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307749
- Sponsor's protocol ID
- MCC-257-A03
- Status last verified
- Dec 2007
- First submitted
- 27 Mar 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20mg, 40mg and 80mg of MCC-257 in Patients With Mild to Moderate Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT00307749
- Acronym / sponsor ID
- MCC-257-A03
- Conditions
- Diabetic Polyneuropathy
- Keywords
- Neuropathy, Nerve Conduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 28 Mar 2006 (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.
The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy
Detailed description
The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: MCC-257 |
| 3 | Experimental | Drug: MCC-257 |
| 4 | Experimental | Drug: MCC-257 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is male or female, 18-70 years of age
- The patient has either type 1 or type 2 diabetes
- The patient has mild to moderate diabetic neuropathy
- The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests
Key exclusion criteria (8 listed)
- Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix
- BMI>40
- A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition
- Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function
- Women of childbearing potential who do not refrain from sexual activity or use adequate contraception
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 |
|---|---|---|
| Placeboonce daily for 24 weeks | Drug | 1 |
| MCC-25720mg, once daily for 24 weeks | Drug | 2 |
| MCC-25740mg, once daily for 24 weeks | Drug | 3 |
| MCC-25780mg, once daily for 24 weeks | Drug | 4 |
Primary outcome
Nerve Conduction Studies
Time frame: Day 1, Week 24
4 secondary outcomes
Nerve fiber density
Time frame: Day 1, Week 24
QST
Time frame: Day 1, Week 12, Week 24
Symptom
Time frame: Day 1, Week 12, Week 24
Clinical Global Impression
Time frame: Week 12, Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
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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.
Professor principal investigator
Information at Mitsubishi Pharma America
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MCC-257 in people with Diabetic Polyneuropathy, run by Tanabe Pharma Corporation.
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 4 inclusion and 8 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 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nerve Conduction Studies (time frame: Day 1, Week 24). 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 28 Dec 2007.