Painful Diabetic Peripheral Neuropathy (PDPN)Phase 2NCT02372578
Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy
A Phase 2 study testing ASP3662 and pregabalin in people with Painful Diabetic Peripheral Neuropathy (PDPN), run by Astellas Pharma Global Development, Inc. at 37 sites in United States.
Trial summary
The purpose of this study is to assess analgesic efficacy of ASP3662 relative to placebo in subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and tolerability of ASP3662 relative to placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy (PDPN)
- What is being tested?
- ASP3662 and pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 37 sitesUnited States
- Study dates
- 27 May 2015to 20 May 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a BMI ≤ 40.
- Subject has all of the following:
- Established diagnosis of diabetes (Type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HgbA1c) ≤ 9.5% at Screening or Randomization.
- Stable diabetic drug regimen for at least 3 months prior to Screening.
- At least a 1 year history of PDPN.
- Diagnosis of PDPN to be confirmed by a score of ≥ 3 on the Michigan Neuropathy Screening Instrument (MNSI) at Screening.
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- Subject has pain intensity score(s) ≥ 4 or ≤ 9 on an 11-point numeric pain rating scale (NPRS) at Screening Visit and prior to Randomization.
- Subject agrees to complete pain diaries and is complaint with the daily pain recording prior to Randomization as defined by the completion of a minimum of 5 of 7 daily pain ratings, 3 of which are required in the last 4 days.
- Subject's anti-diabetic regimen is anticipated to be stable throughout the study.
- Subject must be willing to washout of all medications currently being taken for his/her PDPN (chronic and occasional/as needed) and remain off of those pain medications while participating in the study.
Who cannot join
- Subject has received prior treatment with pregabalin for PDPN and was considered unresponsive or intolerant.
- Subject has tried and failed 3 or more drugs to treat PDPN within the past 3 years. Drugs must have been administered at therapeutic doses and have been administered for an adequate period of time.
- Subject has a known hypersensitivity to ASP3662, pregabalin, gabapentin or acetaminophen, or their formulation components.
- Subject has significant pain (moderate or above) due to causes other than PDPN.
- Subject has a history of painful peripheral neuropathy due to a cause other than diabetes.
- Subject has any lower extremity amputation
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- Subject has a current or previous foot ulcer within the past 3 months as described by medical history and/or medical examination.
- Subject has an active malignancy or a history of malignancy (except for treated non-melanoma skin cancer) within 5 years.
- Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis, or a serum creatinine at Screening.
- Subject has creatinine clearance < 60 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation) at Screening.
- Subject tests positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody at Screening or has a known history of a positive test for human immunodeficiency virus (HIV) infection.
- Subject has a positive drug screen for alcohol or drugs of abuse at Screening and/or Randomization. Subjects who are on low doses of benzodiazepines for sleep with a legitimate prescription will be allowed into the study. In addition, subjects with a positive drug screen at Randomization will be excluded.
- Subject is currently using protocol specified non-permitted medications including OTC products and is unable or does not choose to discontinue them.
- Subject has planned an elective surgery during planned study participation.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Site US10001
Anniston, Alabama, 36207
Site US10009
Aurora, Illinois, 60506
Site US10034
Austin, Texas, 78731
Site US10051
Boston, Massachusetts, 02115
Site US10005
Boynton Beach, Florida, 33436
Site US10023
Bradenton, Florida, 34205
Site US10036
Chicago, Illinois, 60624
Site US10018
Clearwater, Florida, 33765
Site US10019
DeLand, Florida, 32720
Site US10014
Duncansville, Pennsylvania, 16635
Site US10025
Evansville, Indiana, 47714
Site US10053
Fairfield, Connecticut, 06824
Site US10054
Fresno, California, 93720
Site US10015
Greer, South Carolina, 29651
Site US10043
Hazelwood, Missouri, 63042
Site US10004
Homestead, Florida, 33030
Site US10040
Houston, Texas, 77030
Site US10042
Jacksonville, Florida, 32256
Site US10007
Jupiter, Florida, 33458
Site US10013
Kettering, Ohio, 45429
Site US10020
Lomita, California, 90717
Site US10064
Metairie, Louisiana, 70006
Site US10041
Miami Lakes, Florida, 33014
Site US10026
New Bedford, Massachusetts, 02740-2133
Site US10046
Orlando, Florida, 32806
Site US10008
Ormond Beach, Florida, 32174
Site US10003
Oviedo, Florida, 32765
Site US10039
Phoenix, Arizona, 85023
Site US10063
Quincy, Massachusetts, 02169
Site US10045
Renton, Washington, 98057
Site US10033
Salt Lake City, Utah, 84107
Site US10032
San Antonio, Texas, 78218
Site US10031
San Antonio, Texas, 78228
Site US10047
Santa Monica, California, 90404
Site US10049
The Villages, Florida, 32162
Site US10017
Tustin, California, 92780
Site US10055
Walnut Creek, California, 94598
About this study
Official title: A Phase 2a Randomized, Double-Blind, Multicenter, Placebo and Active Controlled Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy
The purpose of this study is to assess analgesic efficacy of ASP3662 relative to placebo in subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and tolerability of ASP3662 relative to placebo.
The analgesic effect is evaluated by measuring percent responders, change in daily worst pain score, change in average daily pain score, Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC).
- Being tested
- ASP3662, pregabalin, ASP3662 placebo, pregabalin placebo
- Keywords
- Painful diabetic peripheral neuropathy (PDPN), ASP3662
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3662Drug
oral
pregabalinDrug
oral
ASP3662 placeboDrug
oral
pregabalin placeboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP3662 | Experimental | ASP3662 once daily (QD) and pregabalin placebo 3 times daily (TID) for Weeks 1 - 6. ASP3662 placebo QD and pregabalin placebo TID for Week 7. Receives: Drug: ASP3662; Drug: ASP3662 placebo; Drug: pregabalin placebo |
| pregabalin | Active comparator | pregabalin TID and ASP3662 placebo QD for Weeks 1 - 7. Receives: Drug: pregabalin; Drug: ASP3662 placebo |
| Placebo | Placebo comparator | ASP3662 placebo QD and pregabalin placebo TID for Weeks 1 - 7. Receives: Drug: ASP3662 placebo; Drug: pregabalin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in mean 24-hour average pain intensity as reported on the NPRS
Numerical Pain Rating Scale (NPRS)
Measured: Baseline to Week 6/ End of Treatment (EOT)
Secondary outcomes (6)
Percentage of Responders in mean 24-hour average pain intensity score
Measured: Baseline to Week 6/ EOT
Change from Baseline in mean of 24-hour average pain intensity score
Measured: Baseline to Weeks 1, 2, 3, 4, 5 and 6
Change from Baseline in mean daily worst pain score
Measured: Baseline to Week 6/ EOT
Change from Baseline in mean daily average pain score
Measured: Baseline to Week 6/ EOT
Patient Global Impression Change (PGIC)
Measured: Week 6/ EOT
Clinical Global Impression of Change (CGIC)
Measured: Week 6/ EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study start27 May 2015
- Primary completion20 May 2016
- Study completion20 May 2016
Why it stopped: The study was terminated due to futility analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Peripheral Neuropathy (PDPN)Studies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372578
- Sponsor's protocol ID
- 3662-CL-0049
- Status last verified
- Mar 2019
- First submitted
- 21 Feb 2015
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Studies conducted with product indications or formulations that remain in development are assessed after study completion to determine if Individual Participant Data can be shared. The plan to share Individual Participant Data is based on the status of product approval or termination of the compound, in addition to other study-specific criteria described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Double-Blind, Multicenter, Placebo and Active Controlled Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT02372578
- Acronym / sponsor ID
- 3662-CL-0049
- Keywords
- Painful diabetic peripheral neuropathy (PDPN), ASP3662
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to futility analysis.
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 May 2015 (actual)
- Primary completion
- 20 May 2016 (actual)
- Study completion
- 20 May 2016 (actual)
- First posted
- 26 Feb 2015 (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 purpose of this study is to assess analgesic efficacy of ASP3662 relative to placebo in subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and tolerability of ASP3662 relative to placebo.
The analgesic effect is evaluated by measuring percent responders, change in daily worst pain score, change in average daily pain score, Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASP3662 | Experimental | Drug: ASP3662, Drug: ASP3662 placebo, Drug: pregabalin placeboASP3662 once daily (QD) and pregabalin placebo 3 times daily (TID) for Weeks 1 - 6. ASP3662 placebo QD and pregabalin placebo TID for Week 7. |
| pregabalin | Active comparator | Drug: pregabalin, Drug: ASP3662 placebopregabalin TID and ASP3662 placebo QD for Weeks 1 - 7. |
| Placebo | Placebo comparator | Drug: ASP3662 placebo, Drug: pregabalin placeboASP3662 placebo QD and pregabalin placebo TID for Weeks 1 - 7. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has a BMI ≤ 40.
- Subject has all of the following:
- Subject has pain intensity score(s) ≥ 4 or ≤ 9 on an 11-point numeric pain rating scale (NPRS) at Screening Visit and prior to Randomization.
- Subject agrees to complete pain diaries and is complaint with the daily pain recording prior to Randomization as defined by the completion of a minimum of 5 of 7 daily pain ratings, 3 of which are required in the last 4 days.
- Subject's anti-diabetic regimen is anticipated to be stable throughout the study.
Key exclusion criteria (14 listed)
- Subject has received prior treatment with pregabalin for PDPN and was considered unresponsive or intolerant.
- Subject has tried and failed 3 or more drugs to treat PDPN within the past 3 years. Drugs must have been administered at therapeutic doses and have been administered for an adequate period of time.
- Subject has a known hypersensitivity to ASP3662, pregabalin, gabapentin or acetaminophen, or their formulation components.
- Subject has significant pain (moderate or above) due to causes other than PDPN.
- Subject has a history of painful peripheral neuropathy due to a cause other than diabetes.
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 |
|---|---|---|
| ASP3662oral | Drug | ASP3662 |
| pregabalinoral | Drug | pregabalin |
| ASP3662 placebooral | Drug | ASP3662, Placebo, pregabalin |
| pregabalin placebooral | Drug | ASP3662, Placebo |
Primary outcome
Change from Baseline in mean 24-hour average pain intensity as reported on the NPRS
Time frame: Baseline to Week 6/ End of Treatment (EOT)
Numerical Pain Rating Scale (NPRS)
6 secondary outcomes
Percentage of Responders in mean 24-hour average pain intensity score
Time frame: Baseline to Week 6/ EOT
Change from Baseline in mean of 24-hour average pain intensity score
Time frame: Baseline to Weeks 1, 2, 3, 4, 5 and 6
Change from Baseline in mean daily worst pain score
Time frame: Baseline to Week 6/ EOT
Change from Baseline in mean daily average pain score
Time frame: Baseline to Week 6/ EOT
Patient Global Impression Change (PGIC)
Time frame: Week 6/ EOT
Clinical Global Impression of Change (CGIC)
Time frame: Week 6/ EOT
Results and safety
The study was stopped early (reason given: The study was terminated due to futility analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: Undecided. Studies conducted with product indications or formulations that remain in development are assessed after study completion to determine if Individual Participant Data can be shared. The plan to share Individual Participant Data is based on the status of product approval or termination of the compound, in addition to other study-specific criteria described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
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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.
Senior Medical Director study director
Astellas Pharma Global Development, Inc.
37 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 ASP3662 and pregabalin in people with Painful Diabetic Peripheral Neuropathy (PDPN), run by Astellas Pharma Global Development, Inc. at 37 sites in United States.
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 10 inclusion and 14 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. 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: The study was terminated due to futility analysis.). 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?
Change from Baseline in mean 24-hour average pain intensity as reported on the NPRS (time frame: Baseline to Week 6/ End of Treatment (EOT)). 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 26 Mar 2019.