Botulinum Toxin Injection to Treat Diffuse Esophageal Spasm (Botox)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01432782
First received: September 9, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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 Intervention
Esophageal Spasm, Diffuse
Drug: Placebo
Drug: Botulinum Toxin Type A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Dysphagia severity score [ Time Frame: One month after treatment ] [ Designated as safety issue: No ]
    the primary outcome variable is the symptom severity score in patients with diffuse esophageal spasm.


Secondary Outcome Measures:
  • Manometry pattern [ Time Frame: One month after treatment ] [ Designated as safety issue: No ]
    Pattern of contractions on stationary esophageal manometry


Estimated Enrollment: 30
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spastic motor disorder in the upper GI tract

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432782

Contacts
Contact: Jan Tack, M.D., Ph.D. +321634425 jan.tack@med.kuleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Vlaanderen, Belgium, 3000
Contact: Jan Tack, M.D.    +3216344225    jan.tack@med.kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Jan Tack, M.D., Ph.D. Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Prof Dr Jan Tack, Professor of Medicine, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01432782     History of Changes
Other Study ID Numbers: BotoxDES
Study First Received: September 9, 2011
Last Updated: September 9, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Weight loss
Dysphagia
Esophageal hypermotility
Chest Pain

Additional relevant MeSH terms:
Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Spasm
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014