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Botox for the esophagus: new hope for swallowing pain?

NCT ID NCT01955174

Symptom relief Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether injecting botulinum toxin (like Botox) into the lower esophagus can ease symptoms of nutcracker esophagus, a condition that causes chest pain and trouble swallowing. Twenty-four adults received either the toxin or a placebo in a double-blind setup. The main goal was to see if symptoms improved enough to lower their Eckardt score below 3.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Aug 2013

Finished

Feb 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient with non-cardiac chest pain and/or dysphagia with global Eckardt score strictly above 3 points or equal to 3 only for " chest pain " or " dysphagia " - Hypercontractile esophagus with normal esogastric junction relaxation based on the Chicago classification in high resolution manometry * Man or woman 18-year old or older * Normal upper gastrointestinal endoscopy within one year before inclusion * Barium swallow without argument for external compression * Effective form of birth control (if applicable) * Signed written informed consent form voluntarily * Patient with health insurance Exclusion Criteria: * Man or woman under 18-year old * Past history of eso-gastric surgery * Evolutive cancer or coagulation disorders * Absence of effective form of birth control (if applicable) * Pregnant woman or woman who plans to become pregnant during the expected length of the study * Breastfeeding woman * Allergy to botulinum toxin or excipients * Myasthenia * Aminoglycoside treatment * Endoscopic contraindication prior to the study * Endoscopic contraindication during the study * Psychiatric or addictive disease which could affect compliance to the constraints of the study * Patient refusing to participate to the study * Language barrier limiting the understanding of the study * Incapability to give consent * Concomitant participation to another research study * No written consent form

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Conditions

The condition(s) this trial relates to.

dyskinesia of esophagus idiopathic achalasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nutcracker oesophagus

Contacts and locations

Locations

  • Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot Pavillon H 5 - Hospices Civils de Lyon

    Lyon, 69437, France

  • Service d'Hépato-Gastro-Entérologie et Oncologie Digestive- Hôpital Haut Lévêque - CHU de Bordeaux

    Bordeaux, 33075, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.