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Botulinum Toxin Injection to Treat Diffuse Esophageal Spasm (Botox)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01432782
Recruitment Status : Unknown
Verified September 2011 by Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : September 13, 2011
Last Update Posted : September 13, 2011
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Esophageal Spasm, Diffuse Drug: Placebo Drug: Botulinum Toxin Type A Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomised Double-blind Sham Study on the Use of Botox for the Treatment of Diffuse Esophageal Spasm
Study Start Date : February 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Muscle Cramps

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo arm: per-endoscopic injection of saline
Drug: Placebo
Saline 4 ml

Active Comparator: Botulinum toxin
Botulinum toxin (Botox) 100 u in 4 ml, injected per-endoscopically
Drug: Botulinum Toxin Type A
per-endoscopic injection of 100 U of botulinum toxin dissolved in 4 ml of saline
Other Name: Botox

Primary Outcome Measures :
  1. Dysphagia severity score [ Time Frame: One month after treatment ]
    the primary outcome variable is the symptom severity score in patients with diffuse esophageal spasm.

Secondary Outcome Measures :
  1. Manometry pattern [ Time Frame: One month after treatment ]
    Pattern of contractions on stationary esophageal manometry

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Spastic motor disorder in the upper GI tract

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01432782

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Contact: Jan Tack, M.D., Ph.D. +321634425

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University Hospitals Leuven Recruiting
Leuven, Vlaanderen, Belgium, 3000
Contact: Jan Tack, M.D.    +3216344225   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Jan Tack, M.D., Ph.D. Universitaire Ziekenhuizen Leuven

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Responsible Party: Prof Dr Jan Tack, Professor of Medicine, Universitaire Ziekenhuizen Leuven Identifier: NCT01432782     History of Changes
Other Study ID Numbers: BotoxDES
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven:
Weight loss
Esophageal hypermotility
Chest Pain

Additional relevant MeSH terms:
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Esophageal Spasm, Diffuse
Esophageal Motility Disorders
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents