Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

Weekly mean of 24-hour average pain score
Change from Baseline to final

Secondary Outcomes (4)

Pain improvement from Baseline to the final evaluation
8-week
Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain
8-week
Global assessments of study drug and pain status
8-week
Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)
8-week

Study Arms (2)

1

EXPERIMENTAL

Drug: ABT-894

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

ABT-894Drug

6 mg BID tablets, 8 weeks of treatment

placeboDrug

BID tablets, 8 weeks of treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and females, age 18 to 75
If female, must be of non-childbearing potential or practicing birth control

Sponsors & Collaborators

AbbVie (prior sponsor, Abbott)
Industrylead

Study Sites (29)

Site Reference ID/Investigator# 6614

Spring Valley, California, 91978, United States

Site Reference ID/Investigator# 6617

Walnut Creek, California, 94598, United States

Site Reference ID/Investigator# 6356

Hollywood, Florida, 33021, United States

Site Reference ID/Investigator# 6615

Tampa, Florida, 33603, United States

Site Reference ID/Investigator# 6358

Wellington, Florida, 33414, United States

Site Reference ID/Investigator# 6609

St Louis, Missouri, 63141, United States

Site Reference ID/Investigator# 7229

MeSH Terms

Interventions

3-(5,6-dichloropyridin-3-yl)-3,6-diazabicyclo(3.2.0)heptane

Study Officials

Rachel Duan, MD
AbbVie
STUDY DIRECTOR

Enrollment

124 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 24, 2007

Study Start

November 2007

Date type not reported

This date has not been verified as actual or estimated.

A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations