AchalasiaPhase 4NCT01903486
Assessing the Efficacy of Steroid Treatment of Achalasia
A Phase 4 study testing Apo-Prednisone Cordorol, Detasone - Prednisone in people with Achalasia, run by Mayo Clinic.
Trial summary
Would systemic steroids be an effective treatment in early variants of achalasia? Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Achalasia
- What is being tested?
- Apo-Prednisone Cordorol, Detasone - Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to 28 Dec 2020
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
Official title: A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia
Would systemic steroids be an effective treatment in early variants of achalasia?
- Conditions
- Achalasia
- Being tested
- Apo-Prednisone Cordorol, Detasone - Prednisone
- Keywords
- Trouble swallowing, dysphagia, disorder of the esophagus
- Medical subject headings
- Esophageal Achalasia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apo-Prednisone Cordorol, Detasone - PrednisoneDrug
Also called Prednisone, Anti-inflamatory, Corticosteroid
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Apo-Prednisone Cordorol, Detasone - Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients with an Eckhart score ≥ 6 at 1 month
Measured: Baseline to 1 month
Secondary outcomes (1)
proportion of patients with symptomatic improvement (Eckardt sore 6 or greater)
Measured: baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startMar 2013
- Primary completion28 Dec 2020
- Study completion28 Dec 2020
Why it stopped: Unable to recruit participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthik Ravi, M.D., Mayo Clinic
- Investigators
- Karthik Ravi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903486
- Sponsor's protocol ID
- 12-009825
- Status last verified
- Nov 2021
- First submitted
- 16 Jul 2013
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia
- ClinicalTrials.gov ID
- NCT01903486
- Acronym / sponsor ID
- 12-009825
- Conditions
- Achalasia
- Keywords
- Trouble swallowing, dysphagia, disorder of the esophagus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 19 Jul 2013 (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.
Would systemic steroids be an effective treatment in early variants of achalasia?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Other | Drug: Apo-Prednisone Cordorol, Detasone - PrednisonePrednisone (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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Apo-Prednisone Cordorol, Detasone - PrednisoneAlso: Prednisone, Anti-inflamatory, CorticosteroidOral 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 | Prednisone |
Primary outcome
the proportion of patients with an Eckhart score ≥ 6 at 1 month
Time frame: Baseline to 1 month
1 secondary outcome
proportion of patients with symptomatic improvement (Eckardt sore 6 or greater)
Time frame: baseline to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Karthik Ravi, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apo-Prednisone Cordorol, Detasone - Prednisone in people with Achalasia, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 17 Nov 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
the proportion of patients with an Eckhart score ≥ 6 at 1 month (time frame: Baseline to 1 month). It is what the study was designed to measure, not a finding.
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 17 Nov 2021.