A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

Diabetic Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01579279
• Other study ID #: M11-210
• Secondary ID: 2011-003939-56
• Status: Terminated
• Phase: Phase 2
• First received: April 16, 2012
• Last updated: September 24, 2013
• Start date: April 2012
• Est. completion date: May 2012

Study information

• Verified date: August 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Mexico: Federal Commission for Protection Against Health RisksHungary: Ministry of Health, Social and Family AffairsRomania: National Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical 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.

Description:

A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathic Pain
• Neuralgia

Intervention

Drug:
• ABT-652 6 mg
6 mg capsules
• ABT-652 12 mg
12 mg capsules
• ABT-652 12 mg - 18 mg
12 mg - 18 mg capsules
• Placebo
Placebo capsules
• Duloxetine
Duloxetine capsules

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 62887	Anaheim	California
United States	Site Reference ID/Investigator# 63703	Brockton	Massachusetts
United States	Site Reference ID/Investigator# 62886	Dallas	Texas
United States	Site Reference ID/Investigator# 62884	DeLand	Florida
United States	Site Reference ID/Investigator# 63710	Milford	Connecticut
United States	Site Reference ID/Investigator# 73913	Olive Branch	Mississippi
United States	Site Reference ID/Investigator# 62826	Orlando	Florida
United States	Site Reference ID/Investigator# 62824	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Neuropathic Pain Symptom Inventory	Measures severity of common neuropathic pain qualities (burning, pressure, squeezing)	12 weeks	No
Secondary	Patient Global Impression of Change	Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication	12 weeks	No
Secondary	Brief Pain Inventory	Capture the subject's severity of pain and interference	12 weeks	No
Secondary	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	12 weeks	No
Secondary	EuroQuality of Life - 5 Dimension -5 Level	Capture's the subject's mobility, self-care, usual activity, pain/discomfort and anxiety/depression	12 weeks	No