Assessing the Efficacy of Steroid Treatment of Achalasia | NCT01903486

Studies
Assessing the Efficacy of Steroid Treatment of Achalasia

NCT01903486

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Nov 17, 2021Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Achalasia

Interventions

Apo-Prednisone Cordorol, Detasone - Prednisone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to recruit participants.

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Dec 28, 2020Actual

Completion Date

Dec 28, 2020Actual

First Submitted Date

Jul 16, 2013

First Submission Date that Met QC Criteria

Jul 16, 2013

First Posted Date

Jul 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2021

Last Update Posted Date

Nov 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prednisone	Other	Prednisone (study medication) at a dose of 40mg for 1 week, then 30mg for 1 week, then 20mg for 1 week, then 10mg for 1 week, and then stop the medication.	Drug: Apo-Prednisone Cordorol, Detasone - Prednisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Apo-Prednisone Cordorol, Detasone - Prednisone	Drug	Oral prednisone (study medication) at a dose of 40mg for 1 week, then 30mg for 1 week, then 20mg for 1 week, then 10mg for 1 week, and then stop the medication.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the proportion of patients with an Eckhart score ≥ 6 at 1 month		Baseline to 1 month

Secondary Outcomes

Measure	Description	Time Frame
proportion of patients with symptomatic improvement (Eckardt sore 6 or greater)		baseline to 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Adults ages 18-90 with a diagnosis of achalasia confirmed by findings on esophageal manometry and barium esophagogram will be eligible for the study.
Eckardt score6 greater or equal to 6 or 2 or greater for dysphagia and/or regurgitation
Symptoms less than 2 years

Exclusion criteria:

Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy and injection;
Greater than mild esophageal dilation
Type 1 achalasia as defined by the Chicago classification scheme7 and/or esophageal diameter > 3cm;
Prior treatment for achalasia
Use of medications that might affect LES pressure such as anticholinergics or calcium channel antagonists
Symptom duration greater than 2 years
Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
Pregnant and lactating females will be excluded as steroids are not thought safe for the fetus.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Karthik Ravi, MD	Mayo Clinic	Principal Investigator

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D004931	Esophageal Achalasia
D003680	Deglutition Disorders

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011241	Prednisone
D000305	Adrenal Cortex Hormones

Ancestor Terms

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided