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Botulinum Toxin Injection to Treat Diffuse Esophageal Spasm

NCT01432782 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-09-13

No results posted yet for this study

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.

Conditions

  • Esophageal Spasm, Diffuse

Interventions

DRUG

Placebo

Saline 4 ml

DRUG

Botulinum Toxin Type A

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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Jan Tack, M.D., Ph.D. · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432782 on ClinicalTrials.gov