NCT01579279

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

September 26, 2013

Status Verified

August 1, 2013

Enrollment Period

1 month

First QC Date

April 16, 2012

Last Update Submit

September 24, 2013

Conditions

Diabetic Neuropathic Pain

Keywords

Diabetic neuropathic painActive controlled phase 2 study

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (5)

  • Neuropathic Pain Symptom Inventory

    12 weeks

  • Patient Global Impression of Change

    12 weeks

  • Brief Pain Inventory

    12 weeks

  • Neuropathic Pain Impact on Quality of Life Questionnaire

    12 weeks

  • EuroQuality of Life - 5 Dimension -5 Level

    12 weeks

Study Arms (5)

ABT-652 6 mg

EXPERIMENTAL

ABT-652 capsules - twice daily

Drug: ABT-652 6 mg

ABT-652 12 mg

EXPERIMENTAL

ABT-652 capsules twice daily

Drug: ABT-652 12 mg

ABT-652 12 mg - 18 mg

EXPERIMENTAL

ABT-652 capsules twice daily

Drug: ABT-652 12 mg - 18 mg

Placebo

PLACEBO COMPARATOR

Placebo capsules twice daily

Drug: Placebo

Duloxetine

ACTIVE COMPARATOR

Duloxetine capsules once daily

Drug: Duloxetine

Interventions

ABT-652 6 mgDRUG

6 mg capsules

ABT-652 6 mg
ABT-652 12 mgDRUG

12 mg capsules

ABT-652 12 mg
ABT-652 12 mg - 18 mgDRUG

12 mg - 18 mg capsules

ABT-652 12 mg - 18 mg
PlaceboDRUG

Placebo capsules

Placebo
DuloxetineDRUG

Duloxetine capsules

Duloxetine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Site Reference ID/Investigator# 62887

Anaheim, California, 92801, United States

Location

Site Reference ID/Investigator# 62824

Walnut Creek, California, 94598, United States

Location

Site Reference ID/Investigator# 63710

Milford, Connecticut, 06460, United States

Location

Site Reference ID/Investigator# 62884

DeLand, Florida, 32720, United States

Location

Site Reference ID/Investigator# 62826

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 63703

Brockton, Massachusetts, 02301, United States

Location

Site Reference ID/Investigator# 73913

Olive Branch, Mississippi, 38654, United States

Location

Site Reference ID/Investigator# 62886

Dallas, Texas, 75231, United States

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wolfram Nothaft, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 17, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

September 26, 2013

Record last verified: 2013-08

Locations

US(8)