Globus SensationPhase 4LyricaNCT05432843
Comparing Pregabalin and Placebo in Patients With Persistent Globus Sensation
A Phase 4 study testing Pregabalin in people with Globus Sensation, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
To evaluate the relative merits, safety and effectiveness of pregabalin in globus patients compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Globus Sensation
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesBelgium
- Study dates
- 12 Mar 2010to Jan 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Globus symptoms for more than three months
- First symptoms > 6 months ago
- Signed informed consent
Who cannot join
- Gabapentin/pregabalin treatment
- Unstable neuroleptic or antidepressive treatment (stable dose during min 8 weeks)
- Symptom relief under PPI treatment (min 8 weeks full dose)
- Patients with persisting esophagitis of Los Angeles grade B or higher under PPI on upper GI endoscopy
- Primary esophageal motility disorder (achalasia, scleroderma, dermatomyositis, …)
- Eosinophilic esophagitis
Show all 10Show fewer
- Candida esophagitis
- Mechanical explanation of symptoms (e.g. stricture in the pharyngo-esophageal region)
- Pregnancy or plans for pregnancy in the next 12 months (in females)
- History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum,
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
University Hospital Leuven
Leuven, België, 3000
Annelies Geeraerts, +32497671229, annelies.geeraerts@kuleuven.be
- Recruiting
Annelies Geeraerts
Leuven, 3000
Annelies Geeraerts, PhD student, 01643385, annelies.geeraerts@kuleuven.be
About this study
Official title: A Randomized Controlled Trial Comparing Pregabalin and Placebo in Patients With Persistent Globus Sensation
To evaluate the relative merits, safety and effectiveness of pregabalin in globus patients compared with placebo.
Read the detailed description
Globus, defined as a feeling of a lump in the throat, unexplained by structural lesions, GERD, or histopathology-based esophageal motility disorders, is a frequently occurring symptom of unknown etiology. Today there is no appropriate treatment for patients with a globus sensation. Pathophysiological mechanisms that have been implicated in the pathogenesis of globus include gastroesophageal reflux disease, oesophageal motor disorders, overactive cricopharyngeal muscle, psychological factors, gastric islet patches in the proximal esophagus and deformations of the cervical spine. However, none of these convincingly explains the clinical picture in globus patients.
Investigators recently observed that a large majority (80%) of patients with persistent globus sensation have a pathological EMG examination of the larynx, indicative of neuropathy in the laryngeal area. The investigators believe that this neuropathy may explain some of the symptoms that are experienced by patients with globus, and may actually contribute to some observations of unclear pathophysiological relevance such as a hyperreactive ciricopharyngeal muscle. Neuropathies may respond to specific therapies, such as the pregabalin.
The aim of the study is to evaluate if treatment with pregabalin (Lyrica®) is effective in these patients. The effect of gabapentin, another anti-epileptic drug with therapeutic efficacy in neuropathy, was evaluated in patients with chronic cough as sign of laryngeal sensory neuropathy. In this study 68% of the patients experienced improvement, with an even higher efficacy in the group of patients with a pathological EMG (80%).
In order to better understand the underlying pathophysiology, and how this responds to therapy, the investigators will also evaluate upper esophageal sphincter high resolution manometric properties during the study. An elevated resting pressure in the upper sphincter was already reported in previous studie, but not confirmed in a more recent study, which did report a hyperreactive UES, mainly characterized by a hyperdynamic respiratory pressure change.
Esophageal inlet patches have also been implicated in the pathogenesis of globus, although the exact mechanism remains unclear. In the present study, all patients will undergo a strict evaluation of the upper part of the esophagus during endoscopy, to document presence or absence of inlet patches.
- Conditions
- Globus Sensation
- Being tested
- Pregabalin, Placebo
- Medical subject headings
- Globus Sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
Patients receive for one week Pregabalin 75 mg and 7 weeks Pregabalin 150 mg
PlaceboDrug
Patients receive a treatment with placebo for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | Treatment with pregabalin in the treatment of globus sensation Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | Treatment with placebo in the treatment of globus sensation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Proportion of patients in clinical remission or improvement after 8 weeks defined by the Glasgow Edinburgh Throat Scale question 12 ("At present, how annoying do you find your throat sensation?") Ranging from 0-7, where 7 is a worse outcome. Clinical remission is defined as scoring a 0 or 1 on this question.
Measured: 8 weeks
Secondary outcomes (5)
GETS overall scores
Improvement of Glasgow Edinburgh Throat Scale (GETS) overall scores compared between both groups will be evaluated after 8 weeks. The total GETS score is 70, the higher the score, much worse are the symptoms.
Measured: 8 weeks
Clinical remission
Proportion of patients in clinical remission or improvement after 4 weeks defined by the Glasgow Edinburgh Throat Scale question 12 ("At present, how annoying do you find your throat sensation?") Ranging from 0-7, where 7 is a worse outcome. Clinical remission is defined as scoring a 0 or 1 on this question.
Measured: 4 weeks
GETS overall scores
Improvement of Glasgow Edinburgh Throat Scale overall scores compared between both groups will be evaluated after 4 weeks. The total GETS score is 70, the higher the score, much worse are the symptoms.
Measured: 4 weeks
Overall Treatment Efficacy
The Overall Treatment Efficacy evaluation will be analysed by considering the score at 8 weeks. Ranging from 0-6, where 6 is a lower treatment efficacy.
Measured: 8 weeks
Weekly GETS overall scores
Improvement of Glasgow Edinburgh Throat Scale overall scores compared between both groups evaluated for each week during the treatment period. Ranging from 0-7, where 7 is a worse outcome. Clinical remission is defined as scoring a 0 or 1 on this question.
Measured: week 1, week 2, week 3, week 4, week 5, week 6, week 7 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start12 Mar 2010
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Globus SensationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel design with open label period
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432843
- Sponsor's protocol ID
- S52107
- Acronym
- Lyrica
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Pregabalin and Placebo in Patients With Persistent Globus Sensation
- ClinicalTrials.gov ID
- NCT05432843
- Acronym / sponsor ID
- Lyrica / S52107
- Conditions
- Globus Sensation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 12 Mar 2010 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 27 Jun 2022 (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.
To evaluate the relative merits, safety and effectiveness of pregabalin in globus patients compared with placebo.
Detailed description
Globus, defined as a feeling of a lump in the throat, unexplained by structural lesions, GERD, or histopathology-based esophageal motility disorders, is a frequently occurring symptom of unknown etiology. Today there is no appropriate treatment for patients with a globus sensation. Pathophysiological mechanisms that have been implicated in the pathogenesis of globus include gastroesophageal reflux disease, oesophageal motor disorders, overactive cricopharyngeal muscle, psychological factors, gastric islet patches in the proximal esophagus and deformations of the cervical spine. However, none of these convincingly explains the clinical picture in globus patients.
Investigators recently observed that a large majority (80%) of patients with persistent globus sensation have a pathological EMG examination of the larynx, indicative of neuropathy in the laryngeal area. The investigators believe that this neuropathy may explain some of the symptoms that are experienced by patients with globus, and may actually contribute to some observations of unclear pathophysiological relevance such as a hyperreactive ciricopharyngeal muscle. Neuropathies may respond to specific therapies, such as the pregabalin.
The aim of the study is to evaluate if treatment with pregabalin (Lyrica®) is effective in these patients. The effect of gabapentin, another anti-epileptic drug with therapeutic efficacy in neuropathy, was evaluated in patients with chronic cough as sign of laryngeal sensory neuropathy. In this study 68% of the patients experienced improvement, with an even higher efficacy in the group of patients with a pathological EMG (80%).
In order to better understand the underlying pathophysiology, and how this responds to therapy, the investigators will also evaluate upper esophageal sphincter high resolution manometric properties during the study. An elevated resting pressure in the upper sphincter was already reported in previous studie, but not confirmed in a more recent study, which did report a hyperreactive UES, mainly characterized by a hyperdynamic respiratory pressure change.
Esophageal inlet patches have also been implicated in the pathogenesis of globus, although the exact mechanism remains unclear. In the present study, all patients will undergo a strict evaluation of the upper part of the esophagus during endoscopy, to document presence or absence of inlet patches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel design with open label period
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Drug: PregabalinTreatment with pregabalin in the treatment of globus sensation |
| Placebo | Placebo comparator | Drug: PlaceboTreatment with placebo in the treatment of globus sensation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years
- Globus symptoms for more than three months
- First symptoms > 6 months ago
- Signed informed consent
Key exclusion criteria (10 listed)
- Gabapentin/pregabalin treatment
- Unstable neuroleptic or antidepressive treatment (stable dose during min 8 weeks)
- Symptom relief under PPI treatment (min 8 weeks full dose)
- Patients with persisting esophagitis of Los Angeles grade B or higher under PPI on upper GI endoscopy
- Primary esophageal motility disorder (achalasia, scleroderma, dermatomyositis, …)
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 |
|---|---|---|
| PregabalinAlso: LyricaPatients receive for one week Pregabalin 75 mg and 7 weeks Pregabalin 150 mg | Drug | Pregabalin |
| PlaceboPatients receive a treatment with placebo for 8 weeks | Drug | Placebo |
Primary outcome
Clinical remission
Time frame: 8 weeks
Proportion of patients in clinical remission or improvement after 8 weeks defined by the Glasgow Edinburgh Throat Scale question 12 ("At present, how annoying do you find your throat sensation?") Ranging from 0-7, where 7 is a worse outcome. Clinical remission is defined as scoring a 0 or 1 on this question.
5 secondary outcomes
GETS overall scores
Time frame: 8 weeks
Clinical remission
Time frame: 4 weeks
GETS overall scores
Time frame: 4 weeks
Overall Treatment Efficacy
Time frame: 8 weeks
Weekly GETS overall scores
Time frame: week 1, week 2, week 3, week 4, week 5, week 6, week 7 and week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Globus Sensation, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. 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 Belgium. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annelies Geeraerts, MsC (016343385, Annelies.Geeraerts@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: 8 weeks). 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 6 Jul 2022.