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Clinical Trial Results:
Clinical trial to assess the efficacy of the fixed combination product Tepilta® in the treatment of radiation-induced oesophagitis compared to its active ingredients oxetacaine and antacids, and to placebo

Summary
EudraCT number	2009-014441-93
Trial protocol	DE AT
Global end of trial date	18 Jan 2017

Results information
Results version number	v1(current)
This version publication date	16 Dec 2017
First version publication date	16 Dec 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

X-03030-3277

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Meda Pharma GmbH & Co. KG

Sponsor organisation address

Benzstr. 1, Bad Homburg, Germany, 61352

Public contact

Group Leader Study Manager, Meda Pharma GmbH & Co. KG (A Mylan company), +49 6172-888-01, 42b@mylan.com

Scientific contact

Clinical Affairs Meda, Meda Pharma GmbH & Co. KG (A Mylan company), +49 06172-888-01, 42b@mylan.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

12 Apr 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

18 Jan 2017

Global end of trial reached?

Yes

Global end of trial date

18 Jan 2017

Was the trial ended prematurely?

Yes

Main objective of the trial

Primary objective: • To prove the combination effect of oxetacaine and antacids, i.e. to demonstrate superior efficacy of Tepilta® versus oxetacaine, antacids, and placebo.

Protection of trial subjects

No specific additional measures to minimise pain and distress were required. The subjects could withdraw from treatment at any time and for any reason.

Background therapy

Evidence for comparator

Actual start date of recruitment

05 Apr 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Austria: 4

Country: Number of subjects enrolled

Germany: 36

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Relevant for inclusion: Score=0 NRS for oesophageal pain, RT or combined RCT of a solid tumour in head/neck/thorax region, min. length of 5cm of the oesophagus must be included in high-dose radiation field, duration of RT 5-8 weeks, radiation dosage, first radiation in the intended area. Other random and exclusion criteria.

Period 1 title

Overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Tepilta

Arm description

Arm type

Experimental

Investigational medicinal product name

Tepilta

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension in sachet

Routes of administration

Oral use

Dosage and administration details

Active dose: 10 ml suspension contain 20 mg oxetacaine, 582 mg aluminium hydroxide and 196 mg magnesium hydroxide. Study medication: Single dose: 1 sachet containing 10 ml of suspension. Minimum daily dose: 3 sachets or 30 ml of suspension. Maximum daily dose: 6 sachets or 60 ml of suspension. Dosing: Minimum: 1 sachet 5 to 10 minutes before breakfast, lunch, and dinner = 3 sachets. On demand: Up to 2 additional sachets on demand per day and up to 1 sachet per night = up to 3 sachets.

Oxetacaine

Arm description

Arm type

Active comparator

Investigational medicinal product name

Oxetacaine

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension in sachet

Routes of administration

Oral use

Dosage and administration details

Active dose: 10 ml suspension contain 20 mg oxetacaine. Study medication: Single dose: 1 sachet containing 10 ml of suspension. Minimum daily dose: 3 sachets or 30 ml of suspension. Maximum daily dose: 6 sachets or 60 ml of suspension. Dosing: Minimum: 1 sachet 5 to 10 minutes before breakfast, lunch, and dinner = 3 sachets. On demand: Up to 2 additional sachets on demand per day and up to 1 sachet per night = up to 3 sachets.

Antacids

Arm description

Arm type

Active comparator

Investigational medicinal product name

Antacids

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension in sachet

Routes of administration

Oral use

Dosage and administration details

Active dose: 10 ml suspension contain 582 mg aluminium hydroxide and 196 mg magnesium hydroxide. Study medication: Single dose: 1 sachet containing 10 ml of suspension. Minimum daily dose: 3 sachets or 30 ml of suspension. Maximum daily dose: 6 sachets or 60 ml of suspension. Dosing: Minimum: 1 sachet 5 to 10 minutes before breakfast, lunch, and dinner = 3 sachets. On demand: Up to 2 additional sachets on demand per day and up to 1 sachet per night = up to 3 sachets.

Placebo

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension in sachet

Routes of administration

Oral use

Dosage and administration details

No active ingredient. Study medication: Single dose: 1 sachet containing 10 ml of suspension. Minimum daily dose: 3 sachets or 30 ml of suspension. Maximum daily dose: 6 sachets or 60 ml of suspension. Dosing: Minimum: 1 sachet 5 to 10 minutes before breakfast, lunch, and dinner = 3 sachets. On demand: Up to 2 additional sachets on demand per day and up to 1 sachet per night = up to 3 sachets.

Number of subjects in period 1	Tepilta	Oxetacaine	Antacids	Placebo
Started	13	13	9	5
Completed	9	10	4	5
Not completed	4	3	5	0
Adverse event, serious fatal	1	-	1	-
Consent withdrawn by subject	1	-	4	-
Adverse event, non-fatal	2	2	-	-
Protocol deviation	-	1	-	-

Baseline characteristics

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Reporting group title

Overall study (overall period)

Reporting group description

Reporting group values	Overall study (overall period)	Total
Number of subjects	40	40
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	25	25
From 65-84 years	15	15
85 years and over	0	0
Gender categorical
Units: Subjects
Female	12	12
Male	28	28

End points

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Reporting group title

Tepilta

Reporting group description

Reporting group title

Oxetacaine

Reporting group description

Reporting group title

Antacids

Reporting group description

Reporting group title

Placebo

Reporting group description

Primary: Time until first requirement of ASPO

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End point title

Time until first requirement of ASPO ^[1]

End point description

End point type

Primary

End point timeframe

Study duration.

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Due to difficulties in recruiting suitable patients and low no. of patients reaching randomisation criteria, the study was stopped prematurely. Efficacy analyses were not performed since the no. of patients was too low to draw meaningful conclusions.

End point values	Tepilta	Oxetacaine	Antacids	Placebo
Number of subjects analysed	0 ^[2]	0 ^[3]	0 ^[4]	0 ^[5]
Units: days
number (not applicable)

Notes
[2] - cf. limitations and caveats: no efficacy analyses performed upon premature stop with low no. of pat.
[3] - cf. limitations and caveats: no efficacy analyses performed upon premature stop with low no. of pat.
[4] - cf. limitations and caveats: no efficacy analyses performed upon premature stop with low no. of pat.
[5] - cf. limitations and caveats: no efficacy analyses performed upon premature stop with low no. of pat.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Treatment emergent adverse events (TEAEs): Those AEs that occur in the time interval from first administration of study medication until 4 days after end of administration.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

13.0

Reporting group title

Tepilta

Reporting group description

Safety analysis set (all patients having received at least one dose of the study medication will be included in the analysis of safety data).

Reporting group title

Oxetacaine

Reporting group description

Safety analysis set (all patients having received at least one dose of the study medication will be included in the analysis of safety data).

Reporting group title

Antacids

Reporting group description

Safety analysis set (all patients having received at least one dose of the study medication will be included in the analysis of safety data).

Reporting group title

Placebo

Reporting group description

Serious adverse events	Tepilta	Oxetacaine	Antacids	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 13 (38.46%)	2 / 12 (16.67%)	2 / 9 (22.22%)	2 / 5 (40.00%)
number of deaths (all causes)	1	0	1	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Skull fracture
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Lymphoedema
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Pancytopenia
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Oesophagitis
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Odynophagia
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Oesophageal stenosis
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleural effusion
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchopneumonia
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Staphylococcal infection
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Tepilta	Oxetacaine	Antacids	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	12 / 13 (92.31%)	10 / 12 (83.33%)	7 / 9 (77.78%)	4 / 5 (80.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Vascular disorders
Hypotension
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Thrombophlebitis
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	0	1	0	0
General disorders and administration site conditions
Mucosal inflammation
subjects affected / exposed	1 / 13 (7.69%)	1 / 12 (8.33%)	1 / 9 (11.11%)	1 / 5 (20.00%)
occurrences all number	1	1	1	1
Fatigue
subjects affected / exposed	1 / 13 (7.69%)	1 / 12 (8.33%)	0 / 9 (0.00%)	1 / 5 (20.00%)
occurrences all number	1	1	0	1
Chest pain
subjects affected / exposed	1 / 13 (7.69%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	1	0	0
Oedema peripheral
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Pyrexia
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Respiratory, thoracic and mediastinal disorders
Dysphonia
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	1	0	1	0
Cough
subjects affected / exposed	1 / 13 (7.69%)	3 / 12 (25.00%)	1 / 9 (11.11%)	2 / 5 (40.00%)
occurrences all number	1	3	1	2
Dyspnoea
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Hiccups
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	0	1	0	0
Psychiatric disorders
Confusional state
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Depression
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Investigations
C-reactive protein increased
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	1	0	1	0
Body temperature increased
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Blood aluminium increased
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Haemoglobin decreased
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Injury, poisoning and procedural complications
Radiation skin injury
subjects affected / exposed	0 / 13 (0.00%)	4 / 12 (33.33%)	1 / 9 (11.11%)	1 / 5 (20.00%)
occurrences all number	0	4	1	1
Cardiac disorders
Sinus tachycardia
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	0	0	1	0
Headache
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	0	1	0	0
Syncope
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	0	1	0	0
Postictal state
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Vocal cord paresis
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	0	0	1	0
Blood and lymphatic system disorders
Leukopenia
subjects affected / exposed	2 / 13 (15.38%)	1 / 12 (8.33%)	2 / 9 (22.22%)	1 / 5 (20.00%)
occurrences all number	2	1	2	1
Anaemia
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	0	1	0	0
Thrombocytopenia
subjects affected / exposed	1 / 13 (7.69%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	1	1	1	0
Neutropenia
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	0	1	0	0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	0	1	0	0
Gastrointestinal disorders
Nausea
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	3 / 9 (33.33%)	1 / 5 (20.00%)
occurrences all number	0	1	3	0
Constipation
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	2 / 9 (22.22%)	2 / 5 (40.00%)
occurrences all number	0	0	2	2
Diarrhoea
subjects affected / exposed	1 / 13 (7.69%)	2 / 12 (16.67%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	2	0	0
Dysphagia
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	2 / 9 (22.22%)	0 / 5 (0.00%)
occurrences all number	0	0	2	0
Odynophagia
subjects affected / exposed	1 / 13 (7.69%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	1	0	0
Vomiting
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	1	0	1	0
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed	2 / 13 (15.38%)	1 / 12 (8.33%)	2 / 9 (22.22%)	0 / 5 (0.00%)
occurrences all number	2	1	2	0
Erythema
subjects affected / exposed	3 / 13 (23.08%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	3	1	1	0
Eczema
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)
occurrences all number	0	0	0	1
Skin hyperpigmentation
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	0	0	1	0
Rash
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)
occurrences all number	0	0	0	1
Skin lesion
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	0	0	1	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	0	0	1	0
Back pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)
occurrences all number	0	0	0	1
Bone pain
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Muscoloskeletal chest pain
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Infections and infestations
Pneumonia
subjects affected / exposed	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	0	1	0	0
Oral candidiasis
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Tracheitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	0	0	1	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	0	0	1	0
Hypokalaemia
subjects affected / exposed	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)
occurrences all number	1	0	0	0
Hyponatraemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)
occurrences all number	0	0	1	0

More information

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Were there any global substantial amendments to the protocol? Yes

11 Apr 2012

Substantial amendment to facilitate recruitment (change of inclusion and exclusion criteria; widening of screening period; additional administrative modifications).

26 Jul 2013

Substantial amendment to facilitate recruitment (removal of gastric inhibitors from list of prohibited prior and concomitant medication; additional administrative modifications).

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
19 Dec 2012	Temporary halt of the trial due to stability issues with parts of study medication batches.	07 Oct 2013

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Due to difficulties in recruiting suitable patients and low no.of patients reaching randomisation criteria, the study was stopped prematurely. Efficacy analyses were not performed since the no. of patients was too low to draw meaningful conclusions.

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Clinical trials

Clinical Trial Results:
Clinical trial to assess the efficacy of the fixed combination product Tepilta® in the treatment of radiation-induced oesophagitis compared to its active ingredients oxetacaine and antacids, and to placebo

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time until first requirement of ASPO

Primary: Time until first requirement of ASPO

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: Clinical trial to assess the efficacy of the fixed combination product Tepilta® in the treatment of radiation-induced oesophagitis compared to its active ingredients oxetacaine and antacids, and to placebo

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time until first requirement of ASPO

Primary: Time until first requirement of ASPO

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
Clinical trial to assess the efficacy of the fixed combination product Tepilta® in the treatment of radiation-induced oesophagitis compared to its active ingredients oxetacaine and antacids, and to placebo