NCT00381719

Brief Summary

This study will explore the safety and effectiveness of different doses of AGN 203818 in treating pain in patients with painful diabetic peripheral neuropathy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

January 7, 2008

Status Verified

December 1, 2007

Enrollment Period

1.1 years

First QC Date

September 26, 2006

Last Update Submit

January 3, 2008

Conditions

Diabetic Neuropathy, Painful

Outcome Measures

Primary Outcomes (1)

  • Reduction in Daily Pain Score

    1 Month

Secondary Outcomes (3)

  • Changes in sleep interference score

    Week 4

  • Beck depression inventory

    Week 4

  • Quality of Life questionnaires

    Week 4

Study Arms (4)

1

EXPERIMENTAL

3 mg

Drug: AGN 203818

2

EXPERIMENTAL

20 mg

Drug: AGN 203818

3

EXPERIMENTAL

60 mg

Drug: AGN 203818

4

PLACEBO COMPARATOR

Placebo

Drug: placebo capsule

Interventions

AGN 203818DRUG

3 mg Capsule twice daily for 4 weeks

1
placebo capsuleDRUG

Capsule twice daily for 4 weeks

4

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of diabetic peripheral neuropathy
  • Moderate to severe neuropathic pain

You may not qualify if:

  • Any other uncontrolled disease
  • Pregnant or nursing females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tacoma, Washington, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 28, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

January 7, 2008

Record last verified: 2007-12

Locations

US(1)