Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain

This study has been terminated.

(No patients were enrolled in this study. The study onset was delayed due to problems with drug acquisition.)

Sponsor:

Information provided by:

Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT00425230

First received: January 19, 2007

Last updated: December 21, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

January 19, 2007

Last Updated Date

December 21, 2010

Start Date ^ICMJE

January 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

McGill Short Form Pain Questionairre

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00425230 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Fiser Side effect scale
visual analog pain scale
Present Pain intensity
Tylenol # 3 consumption

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain

Official Title ^ICMJE

Pilot Study of Use of Duloxetine for the Treatment of Phantom Limb Pain

Brief Summary

This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Chronic Phantom Limb Pain

Intervention ^ICMJE

Drug: Duloxetine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chronic PLP > 6 months
Short-Form McGill Pain Questionnaire Sensory Pain Rating Index raw score ≥ 16
Age ≥ 18 years old
Inpatient or Outpatient
Able to come to all appointments, in the opinion of the investigator
Able to give informed consent, in opinion of investigator

Exclusion Criteria:

Current Major Depressive disorder, Anxiety Disorder, or Psychotic disorder assessed by the Mini International Neuropsychiatric Interview (MINI)
Substance abuse or dependence within the last six months, as assessed by the MINI
Known Diabetes Mellitus to exclude diabetic peripheral neuropathy
History of coronary artery disease, hepatic disease, renal disease
Other pain syndromes
Any unstable medical conditions in the opinion of the investigator
Other psychotropic medications excluding hypnotics

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00425230

Other Study ID Numbers ^ICMJE

06J02H

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Baylor College of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Asif Chaudhry, MD

Baylor College of Medicine

Information Provided By

Baylor College of Medicine

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top