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Diabetic NeuralgiaPhase 2NCT00507936

Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

A Phase 2 study testing ABT-894 and Duloxetine in people with Diabetic Neuralgia and Diabetic Neuropathies, run by AbbVie (prior sponsor, Abbott) at 49 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
ABT-894 and Duloxetine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
280 participants
Where
49 sitesin 7 countries
Study dates
Aug 2007to Oct 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

  • If female, subject is either postmenopausal for at least two (2) years or surgically sterile or is practicing at least one (1) method of birth control.
  • If female, subject must have negative results for pregnancy tests.
  • The subject must have a diagnosis of diabetes mellitus (Type 1 or Type 2) and a diagnosis of DNP.
  • Subject's DNP must be present for a minimum of six (6) months and should have begun in the feet with relative symmetrical onset.
  • Subject has an HgbA1c <= 9. Subjects who have an HgbA1c > 9 and <= 11 may be included in the study.
  • If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method (condom) of birth control for the duration of the study and for 7 days following the last dose of study drug.

Who cannot join

  • The subject has failed previous treatment with duloxetine for DNP.
  • Subject has a diagnosis of narrow-angle glaucoma.
  • Subject has a history of an allergic reaction or intolerance to duloxetine, acetaminophen, or any other NNR agonist.
  • Subject has a diagnosis of fibromyalgia that requires treatment.
  • Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
  • Subject has a history of seizures (febrile may be ok) or major depressive episode within the past two (2) years or major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
Show all 16Show fewer
  • Subject has a history of myocardial infarction (MI) within six (6) months of the Screening Visit.
  • Subject has unstable angina.
  • Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
  • Subject has undergone a cardiac revascularization procedure within 30 days of Screening.
  • Subject has uncontrolled hypertension (HTN) defined as a systolic blood pressure (BP) >= 160 and/or a diastolic blood pressure (BP) >= 100 at Screening and/or Baseline.
  • Subject has a clinically significant abnormal ECG at Screening
  • Subject has an active malignancy of any type or has been diagnosed with or treated for cancer within the past 5 years.
  • Subject has a positive result for drugs of abuse at Screening with the exception of a positive result for a known prescribed medication.
  • Subject's screening laboratory results show hepatitis A, B or C.
  • Subject has a known or suspected history of Human Immunodeficiency Virus (HIV).

Trial locations and contacts

49 sites in 7 countries.

49 sites in 7 countries

United States29 sites

  • Site Reference ID/Investigator# 6052

    Anaheim, California, 92801

  • Site Reference ID/Investigator# 5277

    Brockton, Massachusetts, 02301

  • Site Reference ID/Investigator# 5947

    Cincinnati, Ohio, 45245

  • Site Reference ID/Investigator# 5276

    Clearwater, Florida, 33765

  • Site Reference ID/Investigator# 6869

    Cuyahoga Falls, Ohio, 44223

  • Site Reference ID/Investigator# 7064

    Garden Grove, California, 92845

  • Site Reference ID/Investigator# 6781

    Hialeah, Florida, 33012

  • Site Reference ID/Investigator# 7699

    Houston, Texas, 77074

  • Site Reference ID/Investigator# 5206

    Little Rock, Arkansas, 72205

  • Site Reference ID/Investigator# 5207

    Mesa, Arizona, 85210

  • Site Reference ID/Investigator# 8286

    National City, California, 91950

  • Site Reference ID/Investigator# 6045

    New York, New York, 10003

  • Site Reference ID/Investigator# 5946

    New York, New York, 10022

  • Site Reference ID/Investigator# 5216

    New York, New York, 10065

  • Site Reference ID/Investigator# 7483

    New York, New York, 10128

  • Site Reference ID/Investigator# 7387

    North Little Rock, Arkansas, 72114

  • Site Reference ID/Investigator# 7906

    Omaha, Nebraska, 68131

  • Site Reference ID/Investigator# 7514

    Palm Beach Gardens, Florida, 33418

  • Site Reference ID/Investigator# 6047

    Pasadena, Maryland, 21122

  • Site Reference ID/Investigator# 6053

    Phoenix, Arizona, 85023

  • Site Reference ID/Investigator# 5217

    Portland, Oregon, 97239

  • Site Reference ID/Investigator# 5836

    San Antonio, Texas, 78218

  • Site Reference ID/Investigator# 5899

    San Antonio, Texas, 78229-4801

  • Site Reference ID/Investigator# 5950

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 7187

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 6054

    Seattle, Washington, 98104

  • Site Reference ID/Investigator# 6043

    St Louis, Missouri, 63117

  • Site Reference ID/Investigator# 6044

    St Louis, Missouri, 63141

  • Site Reference ID/Investigator# 8113

    Tampa, Florida, 33603

Other trials in United States

France5 sites

  • Site Reference ID/Investigator# 5258

    Corbeil-Essonnes, 91106

  • Site Reference ID/Investigator# 7696

    Nanterre, 92104

  • Site Reference ID/Investigator# 5260

    Narbonne, 11108

  • Site Reference ID/Investigator# 5171

    Nevers, 58033

  • Site Reference ID/Investigator# 7115

    Nîmes, 30029

Other trials in France

Germany5 sites

  • Site Reference ID/Investigator# 6763

    Berlin, 10115

  • Site Reference ID/Investigator# 7117

    Essen, 45138

  • Site Reference ID/Investigator# 5034

    Frankfurt, 60596

  • Site Reference ID/Investigator# 6760

    Heidelberg, 69120

  • Site Reference ID/Investigator# 6732

    Mainz, D - 55116

Other trials in Germany

Canada3 sites

  • Site Reference ID/Investigator# 8508

    Kingston, K7L 1G1

  • Site Reference ID/Investigator# 8436

    Laval, H7T 2P5

  • Site Reference ID/Investigator# 8481

    Winnipeg, R2V 4W3

Other trials in Canada

Mexico3 sites

  • Site Reference ID/Investigator# 8427

    Guadalajara, 44656

  • Site Reference ID/Investigator# 8497

    Mexico City, C.P. 11650

  • Site Reference ID/Investigator# 8125

    Monterrey, N.L., C.P. 64460

Other trials in Mexico

Italy2 sites

  • Site Reference ID/Investigator# 5018

    Milan, 20132

  • Site Reference ID/Investigator# 5006

    Rome, 00133

Other trials in Italy

Puerto Rico2 sites

  • Site Reference ID/Investigator# 8120

    Ponce, 00717-2075

  • Site Reference ID/Investigator# 8121

    San Juan, 00907

Other trials in Puerto Rico

About this study

Official title: A Global, Multicenter, Randomized, Double-Blind Placebo Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects With Diabetic Neuropathic Pain

This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.

Being tested
ABT-894, placebo, Duloxetine
Keywords
Diabetic Neuropathy, Painful, Diabetic Polyneuropathy, Neuralgia, Diabetic, Diabetic Neuropathies, Diabetic Neuralgia
Medical subject headings
Diabetic Neuropathies, Pain, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-894Drug

    ABT-894 1 mg capsule BID throughout treatment period

  • ABT-894Drug

    ABT-894 2 mg capsule BID throughout treatment period

  • ABT-894Drug

    ABT-894 4 mg capsule BID throughout treatment period

  • placeboDrug

    placebo capsule BID throughout the treatment period

  • DuloxetineDrug

    Duloxetine 60 mg QD throughout treatment period

Study groups in NCT00507936
Study groupRoleWhat they receive
AExperimentalABT-894 1 mg BID
Receives: Drug: ABT-894
BExperimentalABT-894 2 mg BID
Receives: Drug: ABT-894
CExperimentalABT-894 4 mg BID
Receives: Drug: ABT-894
DPlacebo comparatorNot described
Receives: Drug: placebo
EActive comparatorDuloxetine 60 mg QD
Receives: Drug: Duloxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP

    Measured: Change from baseline to final 24-hour average pain score

Secondary outcomes (4)

  1. Proportions of treatment responders; subjects who complete treatment period with 30% improvement

    Measured: From Baseline to final 24-hour average pain score

  2. Mean of 24-hour worst pain severity, average of night pain, and average of morning pain measured by the 11-point Likert scale and from subject's daily diary

    Measured: Weekly through treatment phase

  3. Brief Pain Inventory (BPI) (short form) including Pain Severity

    Measured: At each visit from Baseline to Week 8 visit

  4. Clinician Global Impression: Severity (CGI-S) and Patient Global Impression: Change (PGI-C)

    Measured: At each visit from Baseline to Week 8 visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00507936
Sponsor's protocol ID
M06-850
Other IDs
2007-001139-71
Status last verified
Jan 2013
First submitted
25 Jul 2007
Last updated
23 Jan 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-894 and Duloxetine in people with Diabetic Neuralgia and Diabetic Neuropathies, run by AbbVie (prior sponsor, Abbott) at 49 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 6 inclusion and 16 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 23 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 49 sites in United States, France, Germany, Canada, Mexico 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?

Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP (time frame: Change from baseline to final 24-hour average pain score). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00507936.

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 23 Jan 2013.

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