A Phase 4 interventional study of Pregabalin and Placebo in Globus Sensation, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 2 sites in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-06.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Treatment
To evaluate the relative merits, safety and effectiveness of pregabalin in globus patients compared with placebo.
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.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 958 studies on the registry; 263 are open to participants now.
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Exclusion Criteria:
Treatment with pregabalin in the treatment of globus sensation
Drug: Pregabalin
Treatment with placebo in the treatment of globus sensation
Drug: Placebo
Patients receive for one week Pregabalin 75 mg and 7 weeks Pregabalin 150 mg
Also known as: Lyrica
Patients receive a treatment with placebo for 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 1, week 2, week 3, week 4, week 5, week 6, week 7 and week 8
Correlations
The correlation between Hospital Anxiety Depression Scale scores, Patient Health Questionnaires scores and therapeutic response evaluated at 8 weeks.
Time frame: 8 weeks
Correlation questionnaires and neuropathy
The correlation between Hospital Anxiety Depression Scale scores, Patient Health Questionnaires scores and neuropathy will be evaluated at 8 weeks. The higher score on the Hospital Anxiety Depression Scale and Patient Health Questionnaire, the worse the patients are feeling: more depressed and more anxious and more somatic complaints.
Time frame: 8 weeks
The impact on upper esophageal manometry.
The impact of active or placebo treatment on manometry at 8 weeks. Specific upper esophageal manometry parameters are not yet defined.
Time frame: 8 weeks
Plan to share: Undecided
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Studies of the drug tested here: Pregabalin
Globus Sensation
Universitaire Ziekenhuizen KU Leuven →