Botulinum Toxin Injection to Treat Diffuse Esophageal Spasm

NCT ID: NCT01432782

Last Updated: 2011-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-12-31

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.

Conditions

Esophageal Spasm, Diffuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo arm: per-endoscopic injection of saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Saline 4 ml

Botulinum toxin

Botulinum toxin (Botox) 100 u in 4 ml, injected per-endoscopically

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type: DRUG

per-endoscopic injection of 100 U of botulinum toxin dissolved in 4 ml of saline

Interventions

Placebo

Saline 4 ml

Intervention Type: DRUG

Botulinum Toxin Type A

per-endoscopic injection of 100 U of botulinum toxin dissolved in 4 ml of saline

Intervention Type: DRUG

Other Intervention Names

Botox

Eligibility Criteria

Inclusion Criteria

• Spastic motor disorder in the upper GI tract

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof Dr Jan Tack

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Tack, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

University Hospitals Leuven

Leuven, Flanders, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jan Tack, M.D., Ph.D.

Role: CONTACT

jan.tack@med.kuleuven.be

+321634425

Facility Contacts

Jan Tack, M.D.

Role: primary

jan.tack@med.kuleuven.be

+3216344225

Other Identifiers

BotoxDES

Identifier Type: -

Identifier Source: org_study_id