DysphagiaPhase 2NCT03488147
Whether Proton Pump Inhibitors, Administered Prior to or After Surgery, Can Reduce the Incidence and/or Severity of Difficulty Swallowing Foods and/or Liquids,Following Anterior Cervical Surgery
A Phase 2 study testing Esomeprazole in people with Dysphagia and GERD, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
The researchers wish to investigate whether proton pump inhibitors, administered prior to or after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or liquids,following anterior cervical surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, GERD, Degenerative Joint Disease
- What is being tested?
- Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2020to 2 Jul 2020
- Phase
- Phase 2
- 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
Who may be able to join
- Must be at least 18 years of age.
- Scheduled to undergo anterior cervical surgery for degenerative joint disease.
Who cannot join
- Patients undergoing revision procedures, multi-level procedures, or procedures treating conditions other than degenerative joint disease.
- Patients with preoperative dysphagia.
- Patients currently taking any acid suppressing medications (proton pump inhibitors, H2 blockers, antacids, etc).
- Patients who are pregnant or nursing.
- Patients who, due to drug allergies, hypersensitivities/anaphylactic reactions to esomeprazole or contraindications (hypersensitivity to benzimidazoles, osteoporosis), are unable to take esomeprazole.
- Patients unable to attend follow-up visits or answer the dysphagia questionnaires.
- Eligibility Criteria:
- Scheduled to undergo anterior cervical surgery for degenerative joint disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai West
New York, New York, 10019
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: The Effect of Esomeprazole Magnesium on Incidence of Dysphagia Following Anterior Cervical Spine Surgery: A Prospective, Randomized, Double Blinded, Placebo-Controlled Study
The researchers wish to investigate whether proton pump inhibitors, administered prior to or after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or liquids,following anterior cervical surgery.
Read the detailed description
Over half of patients who underwent anterior cervical surgery may experience dysphagia in the month following the operation. Dysphagia, characterized as difficulty swallowing foods and/or liquids, is a debilitating condition that not only reduces the quality of life for our patients but also results in poor nutritional intake, which may lead to delays in healing and recovery after surgery.
Current understanding of dysphagia following cervical surgery is very rudimentary. Many published reports were retrospective studies where the incidence of dysphagia was later found to be greatly underreported. Furthermore, many studies utilized small sample sizes producing varying data regarding the incidence and severity of postoperative dysphagia. Most importantly, a review of the medical literature failed to find any consistently proven recommendations or therapies that can reduce the incidence or severity of postoperative dysphagia.
A recently published study shows that gastroesophageal reflux disease (GERD) is also a common complaint following anterior cervical surgery. The study also shows a positive correlation between the severity of postoperative GERD and severity of postoperative dysphagia. Other studies also showed that patients suffering from GERD-associated dysphagia may be successfully treated with proton pump inhibitors. Based on these studies, along with anecdotal reports, the investigators hypothesize that proton pump inhibitors may reduce the incidence and/or severity of dysphagia following anterior cervical surgery.
- Conditions
- Dysphagia, GERD, Degenerative Joint Disease
- Being tested
- Esomeprazole, Placebo Oral Tablet
- Keywords
- Esomeprazole Magnesium, Postoperative dysphagia, Gastroesophageal reflux disease, Anterior cervical surgery, Proton pump inhibitor
- Medical subject headings
- Deglutition Disorders, Gastroesophageal Reflux, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
20 mg esomeprazole tablet
Placebo Oral TabletDrug
resembling esomeprazole tablet
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole Only | Experimental | Subjects assigned to the treatment group 'A' will receive one 20 mg esomeprazole tablet daily starting 1 week prior to the cervical operation and will continue to receive the esomeprazole until the end of the study Receives: Drug: Esomeprazole |
| Esomeprazole and Placebo Oral Tablet | Active comparator | Subjects belonging to the treatment group 'B' will receive one placebo tablet (physically resembling an esomeprazole tablet 20 mg ) daily starting one week prior to the cervical operation. Subjects will then receive one 20 mg esomeprazole daily starting immediately after the operation and will continue to receive the esomeprazole until the end of the study. Receives: Drug: Esomeprazole; Drug: Placebo Oral Tablet |
| Placebo Oral Tablet Only | Placebo comparator | Subjects belonging to the treatment group 'C' will receive one placebo tablet (physically resembling a 20 mg esomeprazole tablet) daily starting one week prior to the cervical operation and will continue to receive the placebo tablet until the end of the study Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia questionnaire
The Dysphagia questionnaire is a 2 item questionnaire with full scale from 0 (no swallowing difficulty) to 10 (frequent swallowing difficulty)
Measured: 12 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study startJul 2020 (estimated)
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
Why it stopped: Change in Investigational Drug Service policies resulting in the need to change the operational design of the overall protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After consent has been obtained, eligible subjects will be randomized into 1 of 3 different treatment groups designated A, B, and C, using a random number generator.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Hecht, Icahn School of Medicine at Mount Sinai
- Investigators
- Andrew C Hecht, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488147
- Sponsor's protocol ID
- GCO 12-1433
- Status last verified
- Nov 2020
- First submitted
- 28 Mar 2018
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esomeprazole Magnesium on Incidence of Dysphagia Following Anterior Cervical Spine Surgery: A Prospective, Randomized, Double Blinded, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT03488147
- Acronym / sponsor ID
- GCO 12-1433
- Conditions
- Dysphagia, GERD, Degenerative Joint Disease
- Keywords
- Esomeprazole Magnesium, Postoperative dysphagia, Gastroesophageal reflux disease, Anterior cervical surgery, Proton pump inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in Investigational Drug Service policies resulting in the need to change the operational design of the overall protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 4 Apr 2018 (actual)
- 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.
The researchers wish to investigate whether proton pump inhibitors, administered prior to or after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or liquids,following anterior cervical surgery.
Detailed description
Over half of patients who underwent anterior cervical surgery may experience dysphagia in the month following the operation. Dysphagia, characterized as difficulty swallowing foods and/or liquids, is a debilitating condition that not only reduces the quality of life for our patients but also results in poor nutritional intake, which may lead to delays in healing and recovery after surgery.
Current understanding of dysphagia following cervical surgery is very rudimentary. Many published reports were retrospective studies where the incidence of dysphagia was later found to be greatly underreported. Furthermore, many studies utilized small sample sizes producing varying data regarding the incidence and severity of postoperative dysphagia. Most importantly, a review of the medical literature failed to find any consistently proven recommendations or therapies that can reduce the incidence or severity of postoperative dysphagia.
A recently published study shows that gastroesophageal reflux disease (GERD) is also a common complaint following anterior cervical surgery. The study also shows a positive correlation between the severity of postoperative GERD and severity of postoperative dysphagia. Other studies also showed that patients suffering from GERD-associated dysphagia may be successfully treated with proton pump inhibitors. Based on these studies, along with anecdotal reports, the investigators hypothesize that proton pump inhibitors may reduce the incidence and/or severity of dysphagia following anterior cervical surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- After consent has been obtained, eligible subjects will be randomized into 1 of 3 different treatment groups designated A, B, and C, using a random number generator.
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole Only | Experimental | Drug: EsomeprazoleSubjects assigned to the treatment group 'A' will receive one 20 mg esomeprazole tablet daily starting 1 week prior to the cervical operation and will continue to receive the esomeprazole until the end of the study |
| Esomeprazole and Placebo Oral Tablet | Active comparator | Drug: Esomeprazole, Drug: Placebo Oral TabletSubjects belonging to the treatment group 'B' will receive one placebo tablet (physically resembling an esomeprazole tablet 20 mg ) daily starting one week prior to the cervical operation. Subjects will then receive one 20 mg esomeprazole daily starting immediately after the operation and will continue to receive the esomeprazole until the end of the study. |
| Placebo Oral Tablet Only | Placebo comparator | Drug: Placebo Oral TabletSubjects belonging to the treatment group 'C' will receive one placebo tablet (physically resembling a 20 mg esomeprazole tablet) daily starting one week prior to the cervical operation and will continue to receive the placebo tablet until the end of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be at least 18 years of age.
- Scheduled to undergo anterior cervical surgery for degenerative joint disease.
Key exclusion criteria (8 listed)
- Patients undergoing revision procedures, multi-level procedures, or procedures treating conditions other than degenerative joint disease.
- Patients with preoperative dysphagia.
- Patients currently taking any acid suppressing medications (proton pump inhibitors, H2 blockers, antacids, etc).
- Patients who are pregnant or nursing.
- Patients who, due to drug allergies, hypersensitivities/anaphylactic reactions to esomeprazole or contraindications (hypersensitivity to benzimidazoles, osteoporosis), are unable to take esomeprazole.
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 |
|---|---|---|
| Esomeprazole20 mg esomeprazole tablet | Drug | Esomeprazole Only, Esomeprazole and Placebo Oral Tablet |
| Placebo Oral Tabletresembling esomeprazole tablet | Drug | Esomeprazole and Placebo Oral Tablet, Placebo Oral Tablet Only |
Primary outcome
Dysphagia questionnaire
Time frame: 12 weeks post surgery
The Dysphagia questionnaire is a 2 item questionnaire with full scale from 0 (no swallowing difficulty) to 10 (frequent swallowing difficulty)
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 23 Nov 2020.
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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.
Andrew C Hecht, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esomeprazole in people with Dysphagia and GERD, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
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 2 inclusion and 8 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 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Dysphagia questionnaire (time frame: 12 weeks post surgery). 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 23 Nov 2020.