Radiation-induced OesophagitisPhase 3NCT01336530
Tepilta® Versus Oxetacaine, Antacids and Placebo
A Phase 3 study testing oxetacaine, aluminium and magnesium hydroxide, oxetacaine and magnesium and aluminium hydroxide in people with Radiation-induced Oesophagitis, run by MEDA Pharma GmbH & Co. KG at 32 sites in 2 countries.
Trial summary
This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre trial with 4 parallel treatment groups. The design is adaptive group-sequential with two interim analyses, possible sample size re-estimation after the first or second interim analysis and drop-the-loser approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-induced Oesophagitis
- What is being tested?
- oxetacaine, aluminium and magnesium hydroxide, oxetacaine and magnesium and aluminium hydroxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Apr 2011to Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years.
- Score = 0 on NRS for oesophageal pain.
- Radiotherapy (RT) or combined radio-chemotherapy (RCT) of a solid tumour in head/neck/thorax region. A minimum length of 5 cm of the oesophagus must be included in high-dose radiation field.
- Duration of RT 5 to 8 weeks.
- Single radiation dosage of fractionated RT 1.8 to 2.0 Gy/day, of intensity-modulated RT (IMRT) 1.5 to 2.3 Gy/day, each for 5 days a week (single frequency deviations are allowed presuming that intended duration of RT remains 5 to 8 weeks).
- First radiation in the intended radiation area.
Show all 11Show fewer
- Written informed consent.
- Randomisation criteria:
- Appearance of oesophageal pain as follows: Score ≥ 2 on Numeric Rating Scale (NRS) for pain during main daily meals is reached at least once.
- At least 20 Gy of the dose of radiation therapy in oesophageal area remaining.
- Oesophageal symptoms of grade ≤ 2a according to the adapted Common Terminology Criteria for Adverse Events CTCAE.
Who cannot join
- History of allergic reaction to the study medication or its excipients (i.e. aluminium or magnesium hydroxide, oxetacaine, any other ingredient of study medication).
- Pregnancy, breast-feeding or planned pregnancy during the study.
- Known hypermagnesaemia.
- Known hypophosphataemia.
- Clinically significant obstipation, as judged by the investigator.
- Acute appendicitis.
Show all 23Show fewer
- Total intended radiation dose at lips and the anterior oral cavity > 60% of total intended radiation dose at the swallowing process (pharynx, oesophagus).
- Hyper-fractionated RT.
- Intended naso-gastral tubes.
- Primary tumour of the cranial base, brain, oral cavity, lips, naso-pharynx, para-nasal sinuses.
- Known bone metastases.
- Reflux oesophagitis 3 months prior to the study.
- Continuous systemic pain treatment at the beginning of RT. Systemic pain medication for oesophagitis prior to randomisation must not be taken.
- Concomitant treatment with tetracyclines, cinolone derivatives (ciprofloxacin, ofloxacin, enoxacin, norfloxacin), cheno-desoxycholic acid, sodium fluoride, local anaesthetics (other than those used as study medication).
- Patients relying on levothyroxine after resection of thyroid carcinoma being hypothyroid and patients relying on levothyroxine due to other reasons not being euthyroid.
- Artificial nutrition at the beginning of radiation.
- Drug (licit and illicit) or alcohol abuse which would interfere with the patient's proper completion of the study.
- Exposure to an investigational product within the last 4 weeks, simultaneous exposure to another investigational product.
- Lack of ability or willingness to give informed consent.
- Anticipated non-availability for study visits / procedures.
- Lack of ability or willingness to keep patient's diary.
- Lack of willingness to have personal study related data collected, archived or transmitted according to the protocol.
- Vulnerable subjects.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
Germany30 sites
Universitätsklinikum Aachen
Aachen, 52074
RADIO LOG Strahlentherapie Altötting
Altötting, 84503
please contact Dr. Ingrid Schwienhorst/MEDA for details
Bad Homburg
VIVANTES Klinikum Neukölln
Berlin, 12351
Strahlenheilkunde Westend
Berlin, 14050
Franziskus Hospital
Bielefeld, 33615
Klinik für Hämatologie, Onkologie & Palliativmedizin
Bochum, 44791
Strahlentherapie Bonn-Rhein-Sieg
Bonn, 53177
Städtisches Klinikum Braunschweig GmbH
Braunschweig, 38114
Strahlentherapie Coesfeld
Coesfeld, 48653
Knappschaftskrankenhaus Dortmund
Dortmund, 44309
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), 15236
Krankenhaus Nordwest GmbH
Frankfurt am Main, 60488
Strahlentherapie - Freising
Freising, 85354
Kreiskrankenhaus Gummersbach
Gummersbach, 51643
Universitätsklinikum Halle (Saale)
Halle, 06110
Medizinische Hochschule Hannover
Hanover, 30625
Kath. Krankenhaus Marienhospital
Herne, 44625
Universitätsklinikum Leipzig
Leipzig, 04103
Klinik für Strahlentherapie und Radioonkologie
Marburg, 35033
Kliniken Maria Hilf GmbH
Mönchengladbach, 41063
Gemeinschaftspraxis für Strahlentherapie und Radioonkologie am Klinikum Schwabing
München, 80804
Klinikum der Universität München
München, 81377
Paracelsus-Klinik Osnabrück
Osnabrück, 49076
Paracelsus-Krankenhaus Ruit
Ostfildern, 73760
Brüderkrankenhaus St. Josef
Paderborn, 33098
Klinikum Ernst von Bergmann
Potsdam, 14467
Prosperhospital Recklinghausen
Recklinghausen, 45659
Universitätsklinikum Rostock AöR
Rostock, 18059
Klinik für Radioonkologie und Strahlentherapie
Stuttgart, 70174
Austria2 sites
Landeskrankenhaus Feldkirch
Feldkirch, 6807
Universitätsklinik für Strahlentherapie-Radioonkologie
Innsbruck, 6020
About this study
Official title: Clinical Trial to Assess the Efficacy of Fixed Combination Product Tepilta® in the Treatment of Radiation-induced Oesophagitis Compared to Its Active Ingredients Oxetacaine and Antacids, and to Placebo
This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre trial with 4 parallel treatment groups. The design is adaptive group-sequential with two interim analyses, possible sample size re-estimation after the first or second interim analysis and drop-the-loser approach. The study design was primarily chosen to show superior efficacy of Tepilta® compared to the single components and to placebo. Evaluation of safety is a secondary objective.
Read the detailed description
Tepilta® Suspension is indicated for treatment of pain in the upper digestive system induced by radiation therapy, in particular for radiation-induced oesophagitis.
- Conditions
- Radiation-induced Oesophagitis
- Being tested
- oxetacaine, aluminium and magnesium hydroxide, oxetacaine, magnesium and aluminium hydroxide, Vehicle
- Keywords
- Oesophageal pain, Radiotherapy, Combined radio-chemotherapy, Oesophageal symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxetacaine, aluminium and magnesium hydroxideDrug
Also called Tepilta®
20mg/10ml oxetacaine, 196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
oxetacaineDrug
20mg/10ml oxetacaine. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
magnesium and aluminium hydroxideDrug
Also called Antacids
196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
VehicleOther
Placebo suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tepilta® | Experimental | Not described Receives: Drug: oxetacaine, aluminium and magnesium hydroxide |
| Oxetacaine | Active comparator | Not described Receives: Drug: oxetacaine |
| Antacids | Active comparator | Not described Receives: Drug: magnesium and aluminium hydroxide |
| Placebo | Placebo comparator | Not described Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO).
Measured: up to 11 weeks
Secondary outcomes (8)
ASPO: WHO analgesic pain ladder
ASPO = Additional systemic pain medication for oesophagitis
Measured: up to 11 weeks
Pain intensity recorded on NRS with scores 0-10
NRS = Numeric Rating Scale
Measured: up to 11 weeks
Swallowing disorder recorded on NRS with scores 0-10
NRS = Numeric Rating Scale
Measured: up to 11 weeks
Adapted CTCAE grade
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.
Measured: up to 11 weeks
Incidence of artificial nutrition due to radiation-induced oesophagitis
Measured: up to 11 weeks
Incidence of interruptions of radiation therapy due to radiation-induced oesophagitis
Measured: up to 11 weeks
Duration of pain medication intake after the end of Radiation Therapy
Measured: up to 11 weeks
Loss of body weight
Measured: up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: The study stopped prematurely due to and administrative reasons, not based on grounds of safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced OesophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trium Analysis Online GmbH, ICON plc, Clinipace Worldwide
- Responsible party
- Sponsor
- Investigators
- Frank Bruns, Dr. med., Principal investigator, Hannover Medical SchoolUrsula Petzold, PhD, Study chair, MEDA Pharma GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336530
- Sponsor's protocol ID
- X-03030-3277
- Other IDs
- 2009-014441-93, 2009
- Status last verified
- Feb 2017
- First submitted
- 1 Apr 2011
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Efficacy of Fixed Combination Product Tepilta® in the Treatment of Radiation-induced Oesophagitis Compared to Its Active Ingredients Oxetacaine and Antacids, and to Placebo
- ClinicalTrials.gov ID
- NCT01336530
- Acronym / sponsor ID
- X-03030-3277
- Conditions
- Radiation-induced Oesophagitis
- Keywords
- Oesophageal pain, Radiotherapy, Combined radio-chemotherapy, Oesophageal symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped prematurely due to and administrative reasons, not based on grounds of safety.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- Trium Analysis Online GmbH, ICON plc, Clinipace Worldwide
- Study start
- Apr 2011 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre trial with 4 parallel treatment groups. The design is adaptive group-sequential with two interim analyses, possible sample size re-estimation after the first or second interim analysis and drop-the-loser approach. The study design was primarily chosen to show superior efficacy of Tepilta® compared to the single components and to placebo. Evaluation of safety is a secondary objective.
Detailed description
Tepilta® Suspension is indicated for treatment of pain in the upper digestive system induced by radiation therapy, in particular for radiation-induced oesophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tepilta® | Experimental | Drug: oxetacaine, aluminium and magnesium hydroxide |
| Oxetacaine | Active comparator | Drug: oxetacaine |
| Antacids | Active comparator | Drug: magnesium and aluminium hydroxide |
| Placebo | Placebo comparator | Other: Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female ≥ 18 years.
- Score = 0 on NRS for oesophageal pain.
- Radiotherapy (RT) or combined radio-chemotherapy (RCT) of a solid tumour in head/neck/thorax region. A minimum length of 5 cm of the oesophagus must be included in high-dose radiation field.
- Duration of RT 5 to 8 weeks.
- Single radiation dosage of fractionated RT 1.8 to 2.0 Gy/day, of intensity-modulated RT (IMRT) 1.5 to 2.3 Gy/day, each for 5 days a week (single frequency deviations are allowed presuming that intended duration of RT remains 5 to 8 weeks).
Key exclusion criteria (23 listed)
- History of allergic reaction to the study medication or its excipients (i.e. aluminium or magnesium hydroxide, oxetacaine, any other ingredient of study medication).
- Pregnancy, breast-feeding or planned pregnancy during the study.
- Known hypermagnesaemia.
- Known hypophosphataemia.
- Clinically significant obstipation, as judged by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxetacaine, aluminium and magnesium hydroxideAlso: Tepilta®20mg/10ml oxetacaine, 196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks. | Drug | Tepilta® |
| oxetacaine20mg/10ml oxetacaine. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks. | Drug | Oxetacaine |
| magnesium and aluminium hydroxideAlso: Antacids196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks. | Drug | Antacids |
| VehiclePlacebo suspension for oral intake 3-6 times per day for a maximum of 11 weeks. | Other | Placebo |
Primary outcome
Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO).
Time frame: up to 11 weeks
8 secondary outcomes
ASPO: WHO analgesic pain ladder
Time frame: up to 11 weeks
Pain intensity recorded on NRS with scores 0-10
Time frame: up to 11 weeks
Swallowing disorder recorded on NRS with scores 0-10
Time frame: up to 11 weeks
Adapted CTCAE grade
Time frame: up to 11 weeks
Incidence of artificial nutrition due to radiation-induced oesophagitis
Time frame: up to 11 weeks
Incidence of interruptions of radiation therapy due to radiation-induced oesophagitis
Time frame: up to 11 weeks
Duration of pain medication intake after the end of Radiation Therapy
Time frame: up to 11 weeks
Loss of body weight
Time frame: up to 11 weeks
Results and safety
The study was stopped early (reason given: The study stopped prematurely due to and administrative reasons, not based on grounds of safety.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
Related trials for Radiation-induced Oesophagitis
RecruitingPhase 2
Esomeprazole and Radiation Induced Esophagitis
Radiation Esophagitis, Locally Advanced Lung Carcinoma
Not yet recruitingPhase 2
Spirulina Derivative for Radiation Esophagitis
Radiation-induced Esophagitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Bruns, Dr. med. principal investigator
Hannover Medical School
Ursula Petzold, PhD study chair
MEDA Pharma GmbH & Co. KG
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxetacaine, aluminium and magnesium hydroxide, oxetacaine and magnesium and aluminium hydroxide in people with Radiation-induced Oesophagitis, run by MEDA Pharma GmbH & Co. KG at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study stopped prematurely due to and administrative reasons, not based on grounds of safety.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO). (time frame: up to 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.