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Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy (APTODON)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01325090
First received: March 28, 2011
Last updated: August 19, 2016
Last verified: March 2011

March 28, 2011
August 19, 2016
May 2011
November 2013   (final data collection date for primary outcome measure)
decrease in average pain intensity as measured by the Brief Pain Inventory (BPI) [ Time Frame: one month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01325090 on ClinicalTrials.gov Archive Site
  • VAS in the last 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Neuropathic Pain Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy
Early Administration of Botulinum Toxin Type A (Botox®) in Neuropathic Pain Due to Thoracoscopy or Thoracotomy: a Randomized, Double Blind, Placebo Controlled Study
Botulinum toxin type A has been reported to inhibit the release of various pain neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This action is probably responsible for the analgesic effect of botulinum toxin type A recently demonstrated in patients with neuropathic pain of peripheral origin.In those studies, patients had been suffering for years. The investigators can hypothesizes that earlier administration of Botox in the course of neuropathic pain might prevent central sensitization, that is secondary to peripheral sensitization. The investigators can hope to increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
  • Pain Due to Certain Specified Procedures
  • Neuropathic Pain
  • Drug: BOTOX
    A syringe of 1 ml contain 25 Allergan units.
  • Other: PLACEBO
    The pharmacist will fill syringes in tuberculins of 1 ml with injectable solution of sodium chloride of 0,9 %.
  • Experimental: BOTOX
    Patients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area
    Intervention: Drug: BOTOX
  • Placebo Comparator: PLACEBO
    Patients will receive in one session multiple intradermal injections of placebo , in order to cover the whole painful area
    Intervention: Other: PLACEBO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2014
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • daily pain, for 3 months, secondary to thoracoscopy or thoracotomy, of neuropathic origin (DN4 questionary)

Exclusion Criteria:

  • contraindications for botulinum toxin
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01325090
I09006 / APTODON, 2010-021506-38
No
Not Provided
Not Provided
Marie SENGELEN / Directrice de la Recherche et de l'Innovation, CHU de Limoges
University Hospital, Limoges
Not Provided
Principal Investigator: Danièle RANOUX, MD University Hospital, Limoges
University Hospital, Limoges
March 2011

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