Botulinum Toxin Injection to Treat Diffuse Esophageal Spasm (Botox)
Primary Purpose
Esophageal Spasm, Diffuse
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Placebo
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Spasm, Diffuse focused on measuring Weight loss, Dysphagia, Esophageal hypermotility, Chest Pain
Eligibility Criteria
Inclusion Criteria:
- Spastic motor disorder in the upper GI tract
Exclusion Criteria:
-
Sites / Locations
- University Hospitals LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Botulinum toxin
Arm Description
Placebo arm: per-endoscopic injection of saline
Botulinum toxin (Botox) 100 u in 4 ml, injected per-endoscopically
Outcomes
Primary Outcome Measures
Dysphagia severity score
the primary outcome variable is the symptom severity score in patients with diffuse esophageal spasm.
Secondary Outcome Measures
Manometry pattern
Pattern of contractions on stationary esophageal manometry
Full Information
NCT ID
NCT01432782
First Posted
September 9, 2011
Last Updated
September 9, 2011
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01432782
Brief Title
Botulinum Toxin Injection to Treat Diffuse Esophageal Spasm
Acronym
Botox
Official Title
Prospective Randomised Double-blind Sham Study on the Use of Botox for the Treatment of Diffuse Esophageal Spasm
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effect of botulinum toxin 100 U or saline, injected endoscopically in the distal esophagus, on symptoms and manometry pattern in patients with diffuse esophageal spasm.
Detailed Description
Patients are selected on the basis of a clinical diagnosis of diffuse esophageal spasm, based on endoscopy and manometry.
This is a sham-controlled cross-over study of injection of botulinum toxin or saline, in randomized order, in the distal esophagus.
All patients have undergone esophageal manometry which shows diffuse esophageal spasm, and a 24h pH monitoring/manometry to quantify acid reflux. All drugs prescribed to affect esophageal motility (nitrates, calcium antagonists) are stopped during the study. After randomisation, the patient will undergo standard esophageal manometry to assess baseline esophageal motility. On the same day the patient will be asked to fill out a set of symptom questionnaires including a dysphagia questionnaire. At endoscopy, the active treatment group receives 8 x 12.5 units, each in 0.5 ml, of botulinum toxin A which will be injected in the four quadrants of the esophagus at 2 and 5 cm above the lower esophageal sphincter. In the Sham group 8 * 0.5 ml of physiologic serum will be injected. The randomisation will be performed at the endoscopy unit by a nurse otherwise not involved in the protocol.
After 1 month a stationary manometry and a new esophageal pH/manometry monitoring will be performed, followed by a second endoscopy with injection of saline or botulinum toxin in a cross-over mode. At the time of the second endoscopy each patient will fill out a dysphagia questionnaire. One month later, the dysphagia questionnaire is repeated.
Subsequently, follow-up will occur at the outpatient clinic after 6 and 12 months, with follow-up dysphagia questionnaires but no additional manometries or endoscopies, unless the clinical status deteriorates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Spasm, Diffuse
Keywords
Weight loss, Dysphagia, Esophageal hypermotility, Chest Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm: per-endoscopic injection of saline
Arm Title
Botulinum toxin
Arm Type
Active Comparator
Arm Description
Botulinum toxin (Botox) 100 u in 4 ml, injected per-endoscopically
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline 4 ml
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Botox
Intervention Description
per-endoscopic injection of 100 U of botulinum toxin dissolved in 4 ml of saline
Primary Outcome Measure Information:
Title
Dysphagia severity score
Description
the primary outcome variable is the symptom severity score in patients with diffuse esophageal spasm.
Time Frame
One month after treatment
Secondary Outcome Measure Information:
Title
Manometry pattern
Description
Pattern of contractions on stationary esophageal manometry
Time Frame
One month after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spastic motor disorder in the upper GI tract
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Tack, M.D., Ph.D.
Phone
+321634425
Email
jan.tack@med.kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, M.D., Ph.D.
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaanderen
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Tack, M.D.
Phone
+3216344225
Email
jan.tack@med.kuleuven.be
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin Injection to Treat Diffuse Esophageal Spasm
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