Painful Diabetic NeuropathyPhase 2NCT01056315
A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y
A Phase 2 study testing GRT3938Y in people with Painful Diabetic Neuropathy, run by Grünenthal GmbH at 61 sites in United States.
Trial summary
This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- GRT3938Y
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 553 participants
- Where
- 61 sitesUnited States
- Study dates
- Nov 2009to Jan 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symmetrical painful diabetic peripheral neuropathy
Who cannot join
- History of hypersensitivity, allergy or contraindication to opioids and acetaminophen
- Confounding painful conditions
- Significant vascular disease
- History or risk of seizure
- Chronic disease that might effect drug absorption, distribution, metabolism, or excretion
- Female subjects who are being pregnant or breastfeeding
- Evidence or history of alcohol, medication, or drug abuse
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
Site 225
Asheville, North Carolina
Site 142
Atlanta, Georgia
Site 105
Austin, Texas
Site 211
Baltimore, Maryland
Site 227
Canton, Ohio
Site 128
Chicago, Illinois
Site 223
Chicago, Illinois
Site 233
Cincinnati, Ohio
Site 213
Corpus Christi, Texas
Site 136
Deerfield Beach, Florida
Site 137
Deerfield Beach, Florida
Site 140
Deerfield Beach, Florida
Site 216
Deerfield Beach, Florida
Site 217
Deerfield Beach, Florida
Site 218
Deerfield Beach, Florida
Site 108
East Bridgewater, Massachusetts
Site 129
Escondido, California
Site 127
Fairhope, Alabama
Site 117
Fort Myers, Florida
Site 209
Fullerton, California
Site 115
High Point, North Carolina
Site 130
Homewood, Alabama
Site 110
Houston, Texas
Site 123
Houston, Texas
Site 204
Houston, Texas
Site 210
Houston, Texas
Site 231
Houston, Texas
Site 124
Jacksonville, Florida
Site 228
Jupiter, Florida
Site 113
Las Vegas, Nevada
Site 114
Leawood, Kansas
Site 135
Long Beach, California
Site 230
New York, New York
Site 202
Northridge, California
Site 208
Northridge, California
Site 219
Northridge, California
Site 101
Orlando, Florida
Site 226
Orlando, Florida
Site 102
Paducah, Kentucky
Site 104
Philadelphia, Pennsylvania
Site 106
Philadelphia, Pennsylvania
Site 205
Philadelphia, Pennsylvania
Site 122
Princeton, New Jersey
Site 139
Provo, Utah
Site 109
Rochester, New York
Site 131
San Antonio, Texas
Site 215
San Antonio, Texas
Site 221
San Antonio, Texas
Site 203
San Francisco, California
Site 116
Santa Ana, California
Site 118
Santa Ana, California
Site 121
Santa Ana, California
Site 133
Santa Ana, California
Site 206
Sarasota, Florida
Site 111
Toledo, Ohio
Site 125
Toledo, Ohio
Site 112
Tucson, Arizona
Site 126
Vista, California
Site 214
Vista, California
Site 201
Waterbury, Connecticut
Site 212
West Palm Beach, Florida
About this study
Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Analgesic Efficacy and Safety of a New Analgesic Compared to Placebo in Subjects With Painful Diabetic Peripheral Neuropathy
This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- GRT3938Y, Placebo
- Keywords
- Analgesia, Diabetic Neuropathy, Neuropathic pain, Painful, Chronic pain
- Medical subject headings
- Diabetic Neuropathies, Agnosia, Neuralgia, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT3938YDrug
Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.
PlaceboDrug
Overencapsulated tablets of placebo, 16 weeks treatment.
| Study group | Role | What they receive |
|---|---|---|
| A GRT3983Y | Experimental | Participants randomly assigned to receive GRT3983Y. Receives: Drug: GRT3938Y |
| B Placebo | Placebo comparator | Participants randomly assigned to placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain Intensity
The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).
Measured: Baseline; last 7 days of 12-week maintenance
Secondary outcomes (14)
Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance
Measured: Baseline, Daily scores over entire 12 week maintenance
Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis).
Measured: Baseline, Last 7 days of 12-week maintenance
Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.
Measured: Baseline; daily scores over each week of maintenance
Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).
Measured: Baseline; weekly mean
Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.
Measured: Baseline, weekly mean
Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit).
Measured: Baseline, weekly mean
Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit)
Measured: Baseline, weekly mean
Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).
Measured: Day 29, Day 71 and Day 113.
Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Measured: Baseline, Day 29, Day 71 and Day 113.
EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Measured: Baseline, Day 29, Day 71 and Day 113.
Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Measured: Baseline, Day 29, Day 71 and Day 113.
Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Measured: Baseline, Day 29, Day 71 and Day 113.
Time to Treatment Discontinuation Due to Lack of Efficacy.
Measured: Baseline to time to treatment discontinuation
Assessment of Rescue Medication Usage During the 4-week Titration.
Measured: 4-week titration phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Trial was stopped due to difficult enrolment
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 Painful Diabetic NeuropathyStudies 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, Care provider, Investigator
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056315
- Sponsor's protocol ID
- 131885
- Status last verified
- Oct 2019
- First submitted
- 21 Dec 2009
- Last updated
- 28 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Analgesic Efficacy and Safety of a New Analgesic Compared to Placebo in Subjects With Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01056315
- Acronym / sponsor ID
- 131885
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Analgesia, Diabetic Neuropathy, Neuropathic pain, Painful, Chronic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was stopped due to difficult enrolment
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 3 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A GRT3983Y | Experimental | Drug: GRT3938YParticipants randomly assigned to receive GRT3983Y. |
| B Placebo | Placebo comparator | Drug: PlaceboParticipants randomly assigned to placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symmetrical painful diabetic peripheral neuropathy
Key exclusion criteria (7 listed)
- History of hypersensitivity, allergy or contraindication to opioids and acetaminophen
- Confounding painful conditions
- Significant vascular disease
- History or risk of seizure
- Chronic disease that might effect drug absorption, distribution, metabolism, or excretion
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 |
|---|---|---|
| GRT3938YOverencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment. | Drug | A GRT3983Y |
| PlaceboOverencapsulated tablets of placebo, 16 weeks treatment. | Drug | B Placebo |
Primary outcome
Average Pain Intensity
Time frame: Baseline; last 7 days of 12-week maintenance
The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).
14 secondary outcomes
Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance
Time frame: Baseline, Daily scores over entire 12 week maintenance
Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis).
Time frame: Baseline, Last 7 days of 12-week maintenance
Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.
Time frame: Baseline; daily scores over each week of maintenance
Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).
Time frame: Baseline; weekly mean
Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.
Time frame: Baseline, weekly mean
Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit).
Time frame: Baseline, weekly mean
Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit)
Time frame: Baseline, weekly mean
Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).
Time frame: Day 29, Day 71 and Day 113.
Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Time frame: Baseline, Day 29, Day 71 and Day 113.
EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Time frame: Baseline, Day 29, Day 71 and Day 113.
Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Time frame: Baseline, Day 29, Day 71 and Day 113.
Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Time frame: Baseline, Day 29, Day 71 and Day 113.
Time to Treatment Discontinuation Due to Lack of Efficacy.
Time frame: Baseline to time to treatment discontinuation
Assessment of Rescue Medication Usage During the 4-week Titration.
Time frame: 4-week titration phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
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Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
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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.
Study Director study director
Grünenthal GmbH
61 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 GRT3938Y in people with Painful Diabetic Neuropathy, run by Grünenthal GmbH at 61 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 1 inclusion and 7 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 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 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?
Yes. Results are posted in the registry (first posted 3 May 2012). 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?
Average Pain Intensity (time frame: Baseline; last 7 days of 12-week maintenance). 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 Oct 2019.