Diabetic Neuropathic PainPhase 2NCT00548925
A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
A Phase 2 study testing ABT-894 in people with Diabetic Neuropathic Pain, run by AbbVie (prior sponsor, Abbott) at 29 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathic Pain
- What is being tested?
- ABT-894
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 29 sitesin 7 countries
- Study dates
- Nov 2007to Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, age 18 to 75
- If female, must be of non-childbearing potential or practicing birth control
- Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy
- Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months
- Must be willing to washout of all analgesic medications prior to entry into the study
Who cannot join
- Has other conditions that may cause pain
- Currently receiving analgesic medications for conditions other than diabetic neuropathic pain
- Has a history of certain psychiatric diseases
- Has a history of certain heart or cardiovascular conditions
- Has any clinically significant recent infection, injury, or illness
- Current participation in another clinical study or participation within the past 30 days
Show all 9Show fewer
- Is incapacitated, bedridden or confined to a wheelchair
- Is pregnant and/or breastfeeding
- Previous participation in this study or any other study with this investigational product.
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
United States12 sites
Site Reference ID/Investigator# 6575
Allentown, Pennsylvania, 18103
Site Reference ID/Investigator# 6618
Charlotte, North Carolina, 28211
Site Reference ID/Investigator# 6356
Hollywood, Florida, 33021
Site Reference ID/Investigator# 7229
New Hyde Park, New York, 11042
Site Reference ID/Investigator# 6607
Oklahoma City, Oklahoma, 73103
Site Reference ID/Investigator# 8179
San Antonio, Texas, 78229-4801
Site Reference ID/Investigator# 6616
San Antonio, Texas, 78229
Site Reference ID/Investigator# 6614
Spring Valley, California, 91978
Site Reference ID/Investigator# 6609
St Louis, Missouri, 63141
Site Reference ID/Investigator# 6615
Tampa, Florida, 33603
Site Reference ID/Investigator# 6617
Walnut Creek, California, 94598
Site Reference ID/Investigator# 6358
Wellington, Florida, 33414
Germany5 sites
Site Reference ID/Investigator# 6564
Bad Mergentheim, 97980
Site Reference ID/Investigator# 11201
Berlin, 10115
Site Reference ID/Investigator# 6234
Düsseldorf, 40225
Site Reference ID/Investigator# 11202
Mainz, D - 55116
Site Reference ID/Investigator# 7714
Munich, 80804
Czechia3 sites
Site Reference ID/Investigator# 5552
Hradec Králové, 500 03
Site Reference ID/Investigator# 5554
Olomouc, 77900
Site Reference ID/Investigator# 5553
Zlín, 760 01
France3 sites
Site Reference ID/Investigator# 9363
Corbeil-Essonnes, 91106
Site Reference ID/Investigator# 5557
Limoges, 87042
Site Reference ID/Investigator# 6238
Nevers, 58033
Italy2 sites
Site Reference ID/Investigator# 5549
L’Aquila, 67100
Site Reference ID/Investigator# 5558
Perugia, 06126
Spain2 sites
Site Reference ID/Investigator# 6475
Granada, 18014
Site Reference ID/Investigator# 7911
Sabadell, Barcelona, 8208
United Kingdom2 sites
Site Reference ID/Investigator# 5555
Birmingham, B29 6JD
Site Reference ID/Investigator# 7133
Sheffield, S5 7AU
About this study
Official title: A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 Versus Placebo in Subjects With Diabetic Neuropathic Pain
The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy
- Conditions
- Diabetic Neuropathic Pain
- Being tested
- ABT-894, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-894Drug
6 mg BID tablets, 8 weeks of treatment
placeboDrug
BID tablets, 8 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ABT-894 |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly mean of 24-hour average pain score
Measured: Change from Baseline to final
Secondary outcomes (4)
Pain improvement from Baseline to the final evaluation
Measured: 8-week
Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain
Measured: 8-week
Global assessments of study drug and pain status
Measured: 8-week
Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)
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 posted24 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathic PainStudies 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachel Duan, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548925
- Sponsor's protocol ID
- M10-014
- Other IDs
- 2007-001140-47
- Status last verified
- Jan 2013
- First submitted
- 22 Oct 2007
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 Versus Placebo in Subjects With Diabetic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00548925
- Acronym / sponsor ID
- M10-014
- Conditions
- Diabetic Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Oct 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.
The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ABT-894 |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females, age 18 to 75
- If female, must be of non-childbearing potential or practicing birth control
- Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy
- Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months
- Must be willing to washout of all analgesic medications prior to entry into the study
Key exclusion criteria (9 listed)
- Has other conditions that may cause pain
- Currently receiving analgesic medications for conditions other than diabetic neuropathic pain
- Has a history of certain psychiatric diseases
- Has a history of certain heart or cardiovascular conditions
- Has any clinically significant recent infection, injury, or illness
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 |
|---|---|---|
| ABT-8946 mg BID tablets, 8 weeks of treatment | Drug | 1 |
| placeboBID tablets, 8 weeks of treatment | Drug | 2 |
Primary outcome
Weekly mean of 24-hour average pain score
Time frame: Change from Baseline to final
4 secondary outcomes
Pain improvement from Baseline to the final evaluation
Time frame: 8-week
Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain
Time frame: 8-week
Global assessments of study drug and pain status
Time frame: 8-week
Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)
Time frame: 8-week
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 21 Jan 2013.
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A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
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Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
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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.
Rachel Duan, MD study director
AbbVie
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-894 in people with Diabetic Neuropathic Pain, run by AbbVie (prior sponsor, Abbott) at 29 sites in 7 countries.
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 9 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 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Germany, Czechia, France, Italy and 2 more countries. 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 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?
Weekly mean of 24-hour average pain score (time frame: Change from Baseline to final). 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 21 Jan 2013.