ProctalgiaPhase 2ImpartoxNCT01331356
Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia
A Phase 2 study testing Botox in people with Proctalgia, run by Nantes University Hospital at 2 sites in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proctalgia
- What is being tested?
- Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2010to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Nantes University Hospital
Nantes, 44093
Centre Catherine de Sienne
Nantes, 44200
About this study
Official title: 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)
- Conditions
- Proctalgia
- Being tested
- Botox
- Keywords
- Chronic proctalgia, Botulinum toxin type A, Ganglion Impar, Perineal pain, Pudendal neuralgia, Refractory chronic proctalgia
- Medical subject headings
- Pudendal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia
| Study group | Role | What they receive |
|---|---|---|
| Injection of botulinum toxin type A | Experimental | Not described Receives: Drug: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one month
Secondary outcomes (4)
To assess the adverse events
Measured: 6 month
To assess the duration of action of the product (main score SP)
Measured: 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
Measured: 6 month
To assess the evolution of analgesics consumption
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProctalgiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques LABAT, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331356
- Sponsor's protocol ID
- 10/4-T
- Acronym
- Impartox
- Status last verified
- Oct 2013
- First submitted
- 31 Mar 2011
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01331356
- Acronym / sponsor ID
- Impartox / 10/4-T
- Conditions
- Proctalgia
- Keywords
- Chronic proctalgia, Botulinum toxin type A, Ganglion Impar, Perineal pain, Pudendal neuralgia, Refractory chronic proctalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection of botulinum toxin type A | Experimental | Drug: Botox |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BotoxOne injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia | Drug | Injection of botulinum toxin type A |
Primary outcome
Change from baseline in main score (SP) at 1 month
Time frame: one 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).
4 secondary outcomes
To assess the adverse events
Time frame: 6 month
To assess the duration of action of the product (main score SP)
Time frame: 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
Time frame: 6 month
To assess the evolution of analgesics consumption
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Jacques LABAT, Dr principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botox in people with Proctalgia, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in main score (SP) at 1 month (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2013.