Trial · NCT01336530
Tepilta® Versus Oxetacaine, Antacids and Placebo
NCT01336530, Phase 3, Terminated, MEDA Pharma GmbH & Co. KG
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tepilta® Versus Oxetacaine, Antacids and Placebo. Trials, record NCT01336530. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01336530
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tepilta® Versus Oxetacaine, Antacids and Placebo
- NCT number
- NCT01336530
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Conditions
- Radiation-induced Oesophagitis
- Interventions
- oxetacaine, aluminium and magnesium hydroxide, oxetacaine, magnesium and aluminium hydroxide, Vehicle
- First posted
- 2011-04-18
- Last updated
- 2022-02-07
- Other registries' IDs
- eudract:2009-014441-93
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO). | up to 11 weeks | |
| Secondary | ASPO: WHO analgesic pain ladder | up to 11 weeks | ASPO = Additional systemic pain medication for oesophagitis |
| Secondary | Pain intensity recorded on NRS with scores 0-10 | up to 11 weeks | NRS = Numeric Rating Scale |
| Secondary | Swallowing disorder recorded on NRS with scores 0-10 | up to 11 weeks | NRS = Numeric Rating Scale |
| Secondary | Adapted CTCAE grade | up to 11 weeks | CTCAE = Common Terminology Criteria for Adverse Events Severity of oesophageal symptoms will be evaluated by the investigator according to an adapted CTCAE grading system. In contrast to the original CTCAE classification the adapted version foreseen to be used in this study distinguishes level 2a and 2b. 2a = symptomatic; altered eating/swallowing; oral supplements indicated; requiring predominantly pureed or soft diet, 2b = symptomatic; altered eating/swallowing; oral supplements indicated; requiring predominantly liquid diet. |
| Secondary | Incidence of artificial nutrition due to radiation-induced oesophagitis | up to 11 weeks | |
| Secondary | Incidence of interruptions of radiation therapy due to radiation-induced oesophagitis | up to 11 weeks | |
| Secondary | Duration of pain medication intake after the end of Radiation Therapy | up to 11 weeks | |
| Secondary | Loss of body weight | up to 11 weeks |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01336530
GET https://conductscience.org/api/trials/v1/NCT01336530/registered