Esophageal AchalasiaNCT00004416
Randomized Study of Botulinum Toxin Type A for Achalasia
A study testing botulinum toxin type A in people with Esophageal Achalasia, run by University of Texas.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Achalasia
- What is being tested?
- botulinum toxin type A
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jan 1997to Mar 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
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.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, dose response study. Patients are randomized to one of two treatment arms; each arm receives a different dose of botulinum toxin type A.
All patients undergo a flexible upper gastrointestinal endoscopy. Botulinum toxin is injected into the lower esophageal sphincter into each of 4 quadrants. Some patients may receive a second treatment, depending on response and/or time of relapse.
Patients are followed daily for 7 days, then every 1-6 months for 1-2 years after treatment.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Esophageal Achalasia
- Being tested
- botulinum toxin type A
- Keywords
- achalasia, gastrointestinal disorders, rare disease
- Medical subject headings
- Esophageal Achalasia, Gastrointestinal Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJan 1997
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AchalasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 56 participants
Sponsor and investigators
- Lead sponsor
- University of Texas
- Sponsor type
- University, hospital or other
- Investigators
- Pankaj Jay Pasricha, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004416
- Sponsor's protocol ID
- 199/13308
- Other IDs
- UTMB-FDR001421, JHH-94122903, MCMASTER-FDA, UTMB-97-230, UTMB-BB, UTMB-GCRC-470
- Status last verified
- Apr 2001
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Botulinum Toxin Type A for Achalasia
- ClinicalTrials.gov ID
- NCT00004416
- Acronym / sponsor ID
- 199/13308
- Conditions
- Esophageal Achalasia
- Keywords
- achalasia, gastrointestinal disorders, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- University of TexasUniversity, hospital or other
- Study start
- Jan 1997
- Study completion
- Mar 2002
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, dose response study. Patients are randomized to one of two treatment arms; each arm receives a different dose of botulinum toxin type A.
All patients undergo a flexible upper gastrointestinal endoscopy. Botulinum toxin is injected into the lower esophageal sphincter into each of 4 quadrants. Some patients may receive a second treatment, depending on response and/or time of relapse.
Patients are followed daily for 7 days, then every 1-6 months for 1-2 years after treatment.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin type A | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pankaj Jay Pasricha study chair
University of Texas
Questions about this trial
What is this clinical trial studying?
A study testing botulinum toxin type A in people with Esophageal Achalasia, run by University of Texas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.