NCT01331356

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 7, 2013

Status Verified

October 1, 2013

Enrollment Period

1.8 years

First QC Date

March 31, 2011

Last Update Submit

October 4, 2013

Conditions

Proctalgia

Keywords

Chronic proctalgiaBotulinum toxin type AGanglion ImparPerineal painPudendal neuralgiaRefractory chronic proctalgia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in main score (SP) at 1 month

    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).

    one month

Secondary Outcomes (4)

  • To assess the adverse events

    6 month

  • To assess the duration of action of the product (main score SP)

    6 month

  • 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

    6 month

  • To assess the evolution of analgesics consumption

    6 month

Study Arms (1)

Injection of botulinum toxin type A

EXPERIMENTAL
Drug: Botox

Interventions

BotoxDRUG

One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia

Injection of botulinum toxin type A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nantes University Hospital

Nantes, 44093, France

Location

Centre Catherine de Sienne

Nantes, 44200, France

Location

MeSH Terms

Conditions

Pudendal Neuralgia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Nerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Jean-Jacques LABAT, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2011

First Posted

April 8, 2011

Study Start

October 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 7, 2013

Record last verified: 2013-10

Locations

FR(2)