Trial · NCT01955174
Botulinum Toxin Injection in Hypercontractile Esophagus
NCT01955174, Phase 2, Completed, Hospices Civils de Lyon
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Botulinum Toxin Injection in Hypercontractile Esophagus. Trials, record NCT01955174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01955174
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Botulinum Toxin Injection in Hypercontractile Esophagus
- NCT number
- NCT01955174
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Hospices Civils de Lyon
- Conditions
- Nutcracker Oesophagus
- Interventions
- Esophageal endoscopic injection of botulinum toxin, No injection of botulinum toxin
- First posted
- 2013-10-07
- Last updated
- 2025-12-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical response | 3 months after Botulinum toxin injection or sham procedure | Determination of the percentage of patients with clinical response defined by a global Eckardt score \<3 and individual subscores \<2 |
| Secondary | Clinical symptoms improvement | 12 months after Botulinum toxin injection or sham procedure | Determination of the percentage of patients with clinical response defined by a global Eckardt score \<3 and individual subscores \<2 |
| Secondary | Clinical symptoms improvement | After 2 procedures of Botulinum toxin injection or sham procedure | Determination of the percentage of patients with clinical response defined by a global Eckardt score \<3 and individual subscores \<2 |
| Secondary | Safety | Days 1- 7 after procedure. Month 1,3, 4, 6 and 12 after procedure | Evaluation of chest pain with numerical scale from 0 (no pain) to 10 (worst pain) along the 15 days following the procedure, and percentage of patients experimenting adverse events. |
| Secondary | Quality of life improvement | At the first visit, 3 months, 6 months and 12 months after the first therapeutic procedure (botulinum toxin injection or sham procedure) | Evaluation of the quality of life with the Gastrointestinal Quality of Life Index (GIQLI) |
| Secondary | Weight gain | 3 months, 6 months and 12 months after the first therapeutic procedure (botulinum toxin injection or sham procedure) | Evaluation of weight in kg |
| Secondary | Modification of HRM pattern | 3 and 12 months after the first procedure (botulinum toxin injection or sham procedure) | Change towards normal of specific HRM metrics: decrease of mean Distal Contratile Integral, disappearance of contraction with DCI \> 8 000, increase of the % of contractions with normal Distal Latency |
| Secondary | Clinical and paraclinical characteristics of responders versus non-responders | 12 months after the first therapeutic procedure (botulinum toxin injection or sham procedure) | Age, sex, BMI, associated diseases, esophageal motility disorder according to the Chicago classification, associated medications, severity of symptoms at baseline (Eckardt) score, impairment of QOL at baseline (GIQLI score) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30974039 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01955174
GET https://conductscience.org/api/trials/v1/NCT01955174/registered