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Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy (BTXADMPPNP)

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ClinicalTrials.gov Identifier: NCT02460107
Recruitment Status : Terminated (Enrolling failure (lack of participants))
First Posted : June 2, 2015
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
Medy-Tox
Information provided by (Responsible Party):
Myung Eun Chung, MD, PhD, Catholic University of Korea Saint Paul's Hospital

Tracking Information
First Submitted Date  ICMJE May 29, 2015
First Posted Date  ICMJE June 2, 2015
Last Update Posted Date August 8, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
Pain intensity using numeric rating scale [ Time Frame: 4 weeks after intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02460107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
  • Pain intensity using numeric rating scale [ Time Frame: 1, 8, 12, 24 weeks after intervention ]
  • Quality of life using WHOQOL [ Time Frame: 4,8,12 weeks after intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
Official Title  ICMJE Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia
Intervention  ICMJE
  • Biological: Botulinum toxin type A
  • Other: Normal saline
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: Normal saline
    Normal saline
    Intervention: Other: Normal saline
  • Active Comparator: Botulinum toxin type A 50U
    Botulinum toxin 50U
    Intervention: Biological: Botulinum toxin type A
  • Active Comparator: Botulinum toxin type A 100U
    Botulinum toxin 100U
    Intervention: Biological: Botulinum toxin type A
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
Actual Enrollment  ICMJE
 (submitted: August 6, 2017)
9
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2015)
81
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02460107
Other Study ID Numbers  ICMJE CatholicUKSPH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Myung Eun Chung, MD, PhD, Catholic University of Korea Saint Paul's Hospital
Study Sponsor  ICMJE Catholic University of Korea Saint Paul's Hospital
Collaborators  ICMJE Medy-Tox
Investigators  ICMJE Not Provided
PRS Account Catholic University of Korea Saint Paul's Hospital
Verification Date August 2017

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