Botulinum Toxin Injection to Treat Diffuse Esophageal Spasm

Esophageal Spasm, Diffuse Clinical Trial

— Botox  

Official title:

Prospective Randomised Double-blind Sham Study on the Use of Botox for the Treatment of Diffuse Esophageal Spasm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01432782
• Other study ID #: BotoxDES
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2011
• Last updated: September 9, 2011
• Start date: February 2010
• Est. completion date: December 2013

Study information

• Verified date: September 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Jan Tack, M.D., Ph.D.
• Phone: +321634425
• Email: jan.tack[@]med.kuleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Spastic motor disorder in the upper GI tract

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse
• Spasm

Intervention

Drug:
• Placebo
Saline 4 ml
• Botulinum Toxin Type A
per-endoscopic injection of 100 U of botulinum toxin dissolved in 4 ml of saline

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia severity score	the primary outcome variable is the symptom severity score in patients with diffuse esophageal spasm.	One month after treatment	No
Secondary	Manometry pattern	Pattern of contractions on stationary esophageal manometry	One month after treatment	No