NCT00004416

Brief Summary

OBJECTIVES: I. Compare the efficacy of two doses of botulinum toxin in the treatment of achalasia. II. Compare the safety of these two doses in these patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 1997

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
Last Updated

March 25, 2015

Status Verified

April 1, 2001

First QC Date

October 18, 1999

Last Update Submit

March 24, 2015

Conditions

Esophageal Achalasia

Keywords

achalasiagastrointestinal disordersrare disease

Interventions

botulinum toxin type ADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Diagnosis of achalasia by esophageal manometry and upper endoscopy * Symptomatic including dysphagia, regurgitation, etc. * No esophageal ulcers, Barrett's esophagus, significant esophagitis, or esophageal varices --Patient Characteristics-- * Hematopoietic: Platelet count at least 50,000/mm3 * Hepatic: PT no greater than 3 seconds No severe hepatic problems * Renal: No severe renal problems * Cardiovascular: No recent myocardial infarction No unstable angina No decompensated congestive heart failure * Pulmonary: No severe pulmonary disease with dyspnea at rest * Other: No altered mental status No serious systemic disease Not pregnant

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal AchalasiaGastrointestinal DiseasesRare Diseases

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pankaj Jay Pasricha

    University of Texas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

January 1, 1997

Study Completion

March 1, 2002

Last Updated

March 25, 2015

Record last verified: 2001-04