NCT01432782

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 13, 2011

Status Verified

September 1, 2011

Enrollment Period

3.8 years

First QC Date

September 9, 2011

Last Update Submit

September 9, 2011

Conditions

Esophageal Spasm, Diffuse

Keywords

Weight lossDysphagiaEsophageal hypermotilityChest Pain

Outcome Measures

Primary Outcomes (1)

  • Dysphagia severity score

    the primary outcome variable is the symptom severity score in patients with diffuse esophageal spasm.

    One month after treatment

Secondary Outcomes (1)

  • Manometry pattern

    One month after treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo arm: per-endoscopic injection of saline

Drug: Placebo

Botulinum toxin

ACTIVE COMPARATOR

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

Drug: Botulinum Toxin Type A

Interventions

PlaceboDRUG

Saline 4 ml

Placebo
Botulinum Toxin Type ADRUG

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

Also known as: Botox
Botulinum toxin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spastic motor disorder in the upper GI tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Flanders, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Esophageal Spasm, DiffuseWeight LossDeglutition DisordersChest Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPharyngeal DiseasesOtorhinolaryngologic DiseasesPainNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Jan Tack, M.D., Ph.D.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+321634425jan.tack@med.kuleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 13, 2011

Study Start

February 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 13, 2011

Record last verified: 2011-09

Locations

BE(1)