Comparing Pregabalin and Placebo in Patients With Persistent Globus Sensation

NCT05432843 | Unknown Phase 4

• 1 other identifier: S52107
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the relative merits, safety and effectiveness of pregabalin in globus patients compared with placebo.

Conditions

Globus Sensation

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (5)

• GETS overall scores

  8 weeks

• Clinical remission

  4 weeks

• GETS overall scores

  4 weeks

• Overall Treatment Efficacy

  8 weeks

• Weekly GETS overall scores

  week 1, week 2, week 3, week 4, week 5, week 6, week 7 and week 8

Other Outcomes (3)

• Correlations

  8 weeks

• Correlation questionnaires and neuropathy

  8 weeks

• The impact on upper esophageal manometry.

  8 weeks

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

Treatment with pregabalin in the treatment of globus sensation

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Treatment with placebo in the treatment of globus sensation

Drug: Placebo

Interventions

Pregabalin DRUG

Patients receive for one week Pregabalin 75 mg and 7 weeks Pregabalin 150 mg

Also known as: Lyrica

Pregabalin

Placebo DRUG

Patients receive a treatment with placebo for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Globus symptoms for more than three months
• First symptoms \> 6 months ago
• Signed informed consent

You may not qualify if:

• 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
• 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,

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (2)

University Hospital Leuven

Leuven, België, 3000, Belgium

RECRUITING

Annelies Geeraerts

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Globus Sensation

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Conversion Disorder; Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Annelies Geeraerts, MsC

CONTACT

016343385; Annelies.Geeraerts@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the parallel period, the trial is double blinded. After this blinded treatment period, the code will be broken so that patients which received placebo are able to receive the treatment for another 8 weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Parallel design with open label period

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: March 12, 2010
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

BE (2)