Diabetic Neuropathic PainPhase 2NCT01579279
A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain
A Phase 2 study testing ABT-652 6 mg, ABT-652 12 mg and ABT-652 12 mg - 18 mg in people with Diabetic Neuropathic Pain, run by AbbVie (prior sponsor, Abbott) at 8 sites in United States.
Trial summary
To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic neuropathic pain. People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs. 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-652 6 mg, ABT-652 12 mg and ABT-652 12 mg - 18 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2012to May 2012
- 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 is between the ages of 18-75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
- Subject must have a mean average score of greater than 4 on the 24 hour average pain score (0-10 numerical rating scale) prior to the Baseline Visit.
- Subject has been on a medication for diabetic neuropathic pain for the past 3 months.
Who cannot join
- Subject has clinically symptomatic neuropathic pain conditions that cannot be distinguished from Diabetic Neuropathic Pain or interfere with the pain assessments of Diabetic Neuropathic Pain.
- A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with Diabetic Neuropathic Pain assessments or other functions.
- Subject has clinically significant abnormalities in clinical laboratory tests.
- Subject has taken an opioid chronically, excluding tramadol within the last 3 months prior to Screening.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Site Reference ID/Investigator# 62887
Anaheim, California, 92801
Site Reference ID/Investigator# 63703
Brockton, Massachusetts, 02301
Site Reference ID/Investigator# 62886
Dallas, Texas, 75231
Site Reference ID/Investigator# 62884
DeLand, Florida, 32720
Site Reference ID/Investigator# 63710
Milford, Connecticut, 06460
Site Reference ID/Investigator# 73913
Olive Branch, Mississippi, 38654
Site Reference ID/Investigator# 62826
Orlando, Florida, 32806
Site Reference ID/Investigator# 62824
Walnut Creek, California, 94598
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain
To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic neuropathic pain. People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
Read the detailed description
A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.
- Conditions
- Diabetic Neuropathic Pain
- Being tested
- ABT-652 6 mg, ABT-652 12 mg, ABT-652 12 mg - 18 mg, Placebo, Duloxetine
- Keywords
- Diabetic neuropathic pain, Active controlled phase 2 study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-652 6 mgDrug
6 mg capsules
ABT-652 12 mgDrug
12 mg capsules
ABT-652 12 mg - 18 mgDrug
12 mg - 18 mg capsules
PlaceboDrug
Placebo capsules
DuloxetineDrug
Duloxetine capsules
| Study group | Role | What they receive |
|---|---|---|
| ABT-652 6 mg | Experimental | ABT-652 capsules - twice daily Receives: Drug: ABT-652 6 mg |
| ABT-652 12 mg | Experimental | ABT-652 capsules twice daily Receives: Drug: ABT-652 12 mg |
| ABT-652 12 mg - 18 mg | Experimental | ABT-652 capsules twice daily Receives: Drug: ABT-652 12 mg - 18 mg |
| Placebo | Placebo comparator | Placebo capsules twice daily Receives: Drug: Placebo |
| Duloxetine | Active comparator | Duloxetine capsules once daily Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Average Pain Score
Weekly mean of 24-hour average pain score measured by a 11-point Numeric Rating Scale completed on subject's daily diary.
Measured: 12 weeks
Secondary outcomes (5)
Neuropathic Pain Symptom Inventory
Measures severity of common neuropathic pain qualities (burning, pressure, squeezing)
Measured: 12 weeks
Patient Global Impression of Change
Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication
Measured: 12 weeks
Brief Pain Inventory
Capture the subject's severity of pain and interference
Measured: 12 weeks
Neuropathic Pain Impact on Quality of Life Questionnaire
Captures the subject's assessment of neuropathic pain and the effect it has on the quality of daily life
Measured: 12 weeks
EuroQuality of Life - 5 Dimension -5 Level
Capture's the subject's mobility, self-care, usual activity, pain/discomfort and anxiety/depression
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Study Stopped
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfram Nothaft, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579279
- Sponsor's protocol ID
- M11-210
- Other IDs
- 2011-003939-56
- Status last verified
- Aug 2013
- First submitted
- 16 Apr 2012
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01579279
- Acronym / sponsor ID
- M11-210
- Conditions
- Diabetic Neuropathic Pain
- Keywords
- Diabetic neuropathic pain, Active controlled phase 2 study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Stopped
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Apr 2012 (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 evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic neuropathic pain. People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
Detailed description
A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ABT-652 6 mg | Experimental | Drug: ABT-652 6 mgABT-652 capsules - twice daily |
| ABT-652 12 mg | Experimental | Drug: ABT-652 12 mgABT-652 capsules twice daily |
| ABT-652 12 mg - 18 mg | Experimental | Drug: ABT-652 12 mg - 18 mgABT-652 capsules twice daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules twice daily |
| Duloxetine | Active comparator | Drug: DuloxetineDuloxetine capsules once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is between the ages of 18-75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
- Subject must have a mean average score of greater than 4 on the 24 hour average pain score (0-10 numerical rating scale) prior to the Baseline Visit.
- Subject has been on a medication for diabetic neuropathic pain for the past 3 months.
Key exclusion criteria (4 listed)
- Subject has clinically symptomatic neuropathic pain conditions that cannot be distinguished from Diabetic Neuropathic Pain or interfere with the pain assessments of Diabetic Neuropathic Pain.
- A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with Diabetic Neuropathic Pain assessments or other functions.
- Subject has clinically significant abnormalities in clinical laboratory tests.
- Subject has taken an opioid chronically, excluding tramadol within the last 3 months prior to Screening.
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-652 6 mg6 mg capsules | Drug | ABT-652 6 mg |
| ABT-652 12 mg12 mg capsules | Drug | ABT-652 12 mg |
| ABT-652 12 mg - 18 mg12 mg - 18 mg capsules | Drug | ABT-652 12 mg - 18 mg |
| PlaceboPlacebo capsules | Drug | Placebo |
| DuloxetineDuloxetine capsules | Drug | Duloxetine |
Primary outcome
24-hour Average Pain Score
Time frame: 12 weeks
Weekly mean of 24-hour average pain score measured by a 11-point Numeric Rating Scale completed on subject's daily diary.
5 secondary outcomes
Neuropathic Pain Symptom Inventory
Time frame: 12 weeks
Patient Global Impression of Change
Time frame: 12 weeks
Brief Pain Inventory
Time frame: 12 weeks
Neuropathic Pain Impact on Quality of Life Questionnaire
Time frame: 12 weeks
EuroQuality of Life - 5 Dimension -5 Level
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Study Stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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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.
Wolfram Nothaft, MD study director
AbbVie
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 ABT-652 6 mg, ABT-652 12 mg and ABT-652 12 mg - 18 mg in people with Diabetic Neuropathic Pain, run by AbbVie (prior sponsor, Abbott) at 8 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 3 inclusion and 4 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 Sep 2013. 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 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: Study Stopped). 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?
24-hour Average Pain Score (time frame: 12 weeks). 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 Sep 2013.