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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02460107
Other study ID # CatholicUKSPH
Secondary ID
Status Terminated
Phase Early Phase 1
First received May 29, 2015
Last updated August 6, 2017
Start date May 2015
Est. completion date December 31, 2016

Study information

Verified date August 2017
Source Catholic University of Korea Saint Paul's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date December 31, 2016
Est. primary completion date November 30, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- • more than twenty years of age

- patients should have 4 or more items positive among the 10 items of the DN4 questionnaire.

- persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months

- a pain score of 4 or more on the numeric rating scale

Exclusion Criteria:

- • neuropathic pain caused by confounding factors other than diabetic neuropathic pain

- contraindicated for botulinum toxin type A

- a change in pain medication one month prior to study enrollment

- a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)

- person who received botulinum toxin type A within three months prior to study enrollment

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Botulinum toxin type A

Other:
Normal saline
Placebo

Locations

Country Name City State
Korea, Republic of St. Paul's Hospital, The Catholic University of Korea Seoul

Sponsors (2)

Lead Sponsor Collaborator
Catholic University of Korea Saint Paul's Hospital Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity using numeric rating scale 4 weeks after intervention
Secondary Pain intensity using numeric rating scale 1, 8, 12, 24 weeks after intervention
Secondary Quality of life using WHOQOL 4,8,12 weeks after intervention
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