Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia (Impartox)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01331356
First received: March 31, 2011
Last updated: October 4, 2013
Last verified: October 2013

March 31, 2011
October 4, 2013
October 2010
July 2012   (final data collection date for primary outcome measure)
Change from baseline in main score (SP) at 1 month [ Time Frame: one month ] [ Designated as safety issue: Yes ]
The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in the ganglion Impar (total dose = 100 units) by calculating the main score (SP).
Same as current
Complete list of historical versions of study NCT01331356 on ClinicalTrials.gov Archive Site
  • To assess the adverse events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • To assess the duration of action of the product (main score SP) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • To assess the changing parameters of quality of life: global improvement score / treatment satisfaction assessed by digital scale, international pain scales (MPI, QDSA, QCD) / Beck score and Hospital Anxiety and Depression (HAD) score [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To assess the evolution of analgesics consumption [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To assess the adverse events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • To assess the duration of action of the product (main score SP) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • To assess the changing parameters of quality of life: global improvement score / treatment satisfaction assessed by digital scale, international pain scales (MPI, QDSA, QCD) / Beck and HAD score [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To assess the evolution of analgesics consumption [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia
Prospective Multicenter Pilot Study Evaluating the Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia According to the Criteria of Rome III

The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in the ganglion Impar (total dose = 100 units)

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Proctalgia
Drug: Botox
One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia
Experimental: Injection of botulinum toxin type A
Intervention: Drug: Botox
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • Patient with chronic proctalgia according to the criteria of Rome III
  • Chronic or recurrent rectal pain
  • Pains evolve over periods of at least 20 minutes
  • With the exclusion of other causes of rectal pain: ischemic, inflammatory bowel disease, cryptic lesions, intramuscular abscess, anal fissure, hemorrhoids, prostatitis and isolated coccydynia
  • Pains evolve in a regular way since more than 3 months and the symptoms started since at least 6 months
  • These chronic proctalgia include syndromes of anus elevator and nonspecific functional anorectal pains
  • Patient with positive anesthetic block of ganglion Impar (minimum of 30 days before D0 and maximum of 270 days before D0)
  • Main score (SP) ≥ 4 before infiltration of botulinum toxin type A
  • Signed informed consent
  • Subjects affiliated with an appropriate social security system

Exclusion Criteria:

  • Pain related malignancy
  • Patients with bleeding risk and recent anticoagulant therapy
  • Surgery within 3 months
  • Pre-existing anal incontinence
  • Intolerance of botulinum toxin A, local anesthetics and radio contrast medium
  • Injection of botulinum toxin in any place whatsoever in the previous 3 months
  • Pregnancy and breast feeding
  • Antibiotic treatment by aminoglycosides
  • Recent anti-inflammatory treatment
  • Severe myasthenia
  • Lambert-Eaton syndrome
  • Patients with neurological disorders, dysphagia, food choking or inhalation pneumonia
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01331356
10/4-T
Yes
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Jean-Jacques LABAT, Dr Nantes University Hospital
Nantes University Hospital
October 2013

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