Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Neuralgia Diabetic Neuropathies Diabetic Neuropathy, Painful Diabetic Polyneuropathy Neuralgia, Diabetic

Keywords

Diabetic NeuropathyPainfulDiabetic PolyneuropathyNeuralgiaDiabeticDiabetic NeuropathiesDiabetic Neuralgia

Outcome Measures

Primary Outcomes (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
Change from baseline to final 24-hour average pain score

Secondary Outcomes (4)

Proportions of treatment responders; subjects who complete treatment period with 30% improvement
From Baseline to final 24-hour average pain score
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
Weekly through treatment phase

Study Arms (5)

A

EXPERIMENTAL

ABT-894 1 mg BID

Drug: ABT-894

B

EXPERIMENTAL

ABT-894 2 mg BID

Drug: ABT-894

C

EXPERIMENTAL

ABT-894 4 mg BID

Drug: ABT-894

Interventions

ABT-894Drug

ABT-894 1 mg capsule BID throughout treatment period

ABT-894Drug

ABT-894 2 mg capsule BID throughout treatment period

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

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.

Sponsors & Collaborators

AbbVie (prior sponsor, Abbott)
Industrylead

Study Sites (49)

Site Reference ID/Investigator# 5207

Mesa, Arizona, 85210, United States

Site Reference ID/Investigator# 6053

Phoenix, Arizona, 85023, United States

Site Reference ID/Investigator# 5206

Little Rock, Arkansas, 72205, United States

Site Reference ID/Investigator# 7387

North Little Rock, Arkansas, 72114, United States

Site Reference ID/Investigator# 6052

Anaheim, California, 92801, United States

Site Reference ID/Investigator# 7064

Garden Grove, California, 92845, United States

Site Reference ID/Investigator# 8286

MeSH Terms

Conditions

Diabetic NeuropathiesPainNeuralgia

Interventions

3-(5,6-dichloropyridin-3-yl)-3,6-diazabicyclo(3.2.0)heptaneDuloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Wolfram Nothaft, MD
AbbVie
STUDY DIRECTOR

Enrollment

280 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 27, 2007

Study Start

August 2007

Date type not reported

This date has not been verified as actual or estimated.

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

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (5)

A

B

C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (49)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

D

E

You may not qualify if:

Intervention Hierarchy (Ancestors)

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

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (5)

A

B

C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (49)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

D

E

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations