Prospective Randomised Double-blind Sham Study on the Use of Botox for the Treatment of Diffuse esophageal spasm

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018298-39-BE

Enrollment

Unknown

Registered

2010-01-26

Start date

2010-02-15

Completion date

Unknown

Last updated

2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the effect of Botox on symptoms and manometry patterns in patients with diffuse esophageal spasm. MedDRA version: 12.1 Level: LLT Classification code 10015390 Term: Esophageal spasm

Interventions

Trade Name: Botox Pharmaceutical Form: Injection* CAS Number: 93384-43-1 Other descriptive name: BOTULINUM TOXIN TYPE A Concentration unit: IU international unit(s) Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients over the age of 18 years old, with a manometric and clinical diagnosis of diffuse esophageal spasm are eligible for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a history of esophageal surgery, erosive esophagitis, organic esophageal stenosis, achalasia or eosinophilic esophagitis.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary endpoint of the study is to evaluate the effect of an injection with botulinum toxin in the distal esophagus on symptoms and esophageal manometry findings in patients with diffuse esophageal spasm. ;Secondary Objective: A second endpoint of the study is to evaluate the long-term evolution of improvement after treatment. ;Primary end point(s): Symptom severity assessed by a validated questionnaire.	—

Measure

Time frame

Main Objective: The primary endpoint of the study is to evaluate the effect of an injection with botulinum toxin in the distal esophagus on symptoms and esophageal manometry findings in patients with diffuse esophageal spasm. ;Secondary Objective: A second endpoint of the study is to evaluate the long-term evolution of improvement after treatment. ;Primary end point(s): Symptom severity assessed by a validated questionnaire.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026