Clinical Trials Register

Summary
EudraCT Number:	2017-001100-30
Sponsor's Protocol Code Number:	1334hew16ct
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-07-19
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2017-001100-30

A.3

Full title of the trial

Investigation of efficacy and tolerability of the healing water Staatl. Fachingen STILL in patients for symptomatic treatment of heartburn in comparison to placebo

Untersuchung zur Wirksamkeit und Verträglichkeit eines Heilwassers zur symptomatischen Behandlung von Sodbrennen

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Investigation of efficacy and tolerability of the healing water Staatl. Fachingen STILL in patients for symptomatic treatment of heartburn in comparison to placebo

Untersuchung zur Wirksamkeit und Verträglichkeit eines Heilwassers zur symptomatischen Behandlung von Sodbrennen

A.3.2

Name or abbreviated title of the trial where available

Healing water efficacy in heartburn

A.4.1

Sponsor's protocol code number

1334hew16ct

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fachingen Heil- und Mineralbrunnen GmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fachingen Heil- und Mineralbrunnen GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fachingen Heil- und Mineralbrunnen GmbH
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Brunnenstrasse 11
B.5.3.2	Town/ city	Birlenbach OT Fachingen/Lahn
B.5.3.3	Post code	65626
B.5.3.4	Country	Germany
B.5.4	Telephone number	+496432983468
B.5.5	Fax number	+496432983499
B.5.6	E-mail	marketing@fachingen.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Staatl. Fachingen STILL
D.2.1.1.2	Name of the Marketing Authorisation holder	Fachingen Heil- und Mineralbrunnen GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Staatl. Fachingen STILL
D.3.2	Product code	6959688.00.00
D.3.4	Pharmaceutical form	Oral liquid
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Healing water
D.3.9.3	Other descriptive name	HYDROGEN CARBONATE
D.3.9.4	EV Substance Code	SUB37053
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.769
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Healing water

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oral liquid
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Efficacy and tolerability investigations of a healing water in symptomatic treatment of heartburn

E.1.1.1

Medical condition in easily understood language

Efficacy and tolerability investigations of a healing water in symptomatic treatment of heartburn

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10019326
E.1.2	Term	Heartburn
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is:
• • to demonstrate superiority of Staatl. Fachingen STILL compared to placebo with regard to the responder rate by means of change in RDQ score in the dimension heartburn

E.2.2

Secondary objectives of the trial

The secondary objectives are:
• characterisation of therapeutic progress by means of questionnaires (RDQ/QOLRAD) determined at each visit
• characterisation of efficacy based on frequency and intensity of daily heartburn episodes
• evaluation of treatment satisfaction for medication (TSQM-9) by patient at each visit under treatment
• evaluation of treatment by investigator at each visit under treatment
• use of rescue medication
• evaluation of body weight after treatment compared to baseline
• documentation and analysis of AEs (frequency and severity)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

At screening visit:
1. history of repeatedly occurring episodes of heartburn with first manifestation at least 6 months ago
2. repeatedly occurring episodes of heartburn on at least 2 days per week within each of the last 4 weeks prior to screening visit
3. RDQ score of ≥ 8 in the dimension "heartburn" considering the last 7 days prior to screening visit
4. availability of results of a gastric endoscopy within 5 years before screening visit excluding relevant erosive disease (reflux esophagitis), i.e. assessment according to Los Angeles Classification not higher than grade A, and other severe gastrointestinal diseases including malignancies, ulcer, Barett’s oesophagus, and oesophageal varices
5. age: 18 years or older
6. willing and able to ingest at least 1.5 L water per day during the course of the trial
7. willing not to change general eating habits for the duration of the trial, i.e. no special diet planned
8. written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the patients participating in the clinical trial
Furthermore, at baseline visit:
9. RDQ score of ≥ 8 in the dimension "heartburn" considering the last 7 days prior to baseline visit
10. intake of at least 1.5 L water or other beverages per day on at least 10 days over the last 14 days prior to baseline visit

E.4

Principal exclusion criteria

Safety concerns
1. symptoms occurring after the time of gastric endoscopic examination:
a) difficulty in swallowing (dysphagia) or painful swallowing (odynophagia)
b) non-intended weight loss ≥ 5 % of body weight
c) iron deficiency anaemia
d) experiencing episodes of persistent vomiting (at least 7 to 10 days of protracted vomiting) without causal explanation like GI virus infection
2. signs of severe renal impairment known from medical history or reported during screening examination
3. severe heart failure (i.e. NYHA III/IV)
4. known Zollinger Ellison syndrome
5. active or known inflammatory bowel diseases (e.g. colitis ulcerosa, Crohn´s disease) or other severe chronic intestinal disease (e.g. colonic stenosis)
6. diagnosed irritable bowel syndrome
7. patients, who rely on regular intake of medicines with pH-dependent absorption (i.e. HIV protease inhibitors, tyrosine kinase inhibitors)
8. known calcaemia (e.g. as a result of hyperparathyroidis, vitamine D overdose, paraneoplastic syndrome)
9. known nephrolithiasis due to calcium-containing kidney stones
10. known hypophosphatemia
11. known hypercalciuria
12. known hereditary problems of fructose intolerance, glucose-galactose malabsorption or saccharase isomaltase deficiency
13. patients with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
Lack of suitability for the clinical trial
14. history of surgical intervention at oesophagus or gastric and jejunal area
15. known or suspected drug or alcohol abuse within the last year
16. known or suspected eating disorders (e.g. bulimia)
17. continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs e.g. piroxicam, ketoprofen, diclofenac, acetylsalicylic acid or indomethacin (occasionally treatment with NSAIDs or except for ASS 100 mg daily is permitted, see also chapter 13.4.4.))
18. use of PPIs within 4 weeks prior to screening visit
19. participation in a clinical trial during the last 30 days prior to individual enrolment of the patient
For female patients with childbearing potential only:
20. positive pregnancy test at screening examination
21. pregnant women
22. female patients who do not agree to apply highly effective contraceptive methods
Administrative reasons
23. patients suspected or known not to follow instructions especially with regard to drinking habits and general eating habits during the study
24. patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
25. patients with close affiliation with the sponsor or the investigational site; e.g. close relative of the investigator or a dependent person (e.g. employee)
Furthermore, at baseline visit:
26. severe renal impairment (i.e. eGFR ≤ 29 mL/min/1.73 m2 determined from serum creatinine during screening)
27. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
28. use of PPIs within 4 weeks prior to baseline visit (during run-in period)
29. use of H2-receptor antagonists, prokinetics, healing waters or antacids other than the rescue medication within 2 weeks prior to baseline visit (during run-in period)

E.5 End points

E.5.1

Primary end point(s)

The symptom rating score of the RDQ in the dimension of heartburn will serve for determination of the primary variable

E.5.1.1

Timepoint(s) of evaluation of this end point

after data base closure

E.5.2

Secondary end point(s)

• absolute change from baseline in dimension "heartburn", “regurgitation” and “dyspeptic complaints” of the RDQ at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5))
• absolute change from baseline in dimension "heartburn", “regurgitation” and “dyspeptic complaints” of the RDQ considering “frequency” at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5))
• absolute change from baseline in dimension "heartburn" “regurgitation” and “dyspeptic complaints” of the RDQ considering “severity” at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5))
• absolute change from baseline in the total score of the RDQ at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5))
• absolute change from baseline in the total score of the QOLRAD at each a visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5))
• absolute change from baseline in each category of the QOLRAD at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5))
• evaluation of treatment satisfaction for medication (TSQM-9) by patient at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5))
• evaluation of effectiveness and safety/tolerability of the treatment by investigator (VRS) at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5))
• use of rescue medication
• absolute change in body weight after treatment compared to baseline

E.5.2.1

Timepoint(s) of evaluation of this end point

The secondary endpoint for evaluation of efficacy will be determined after 6 weeks of treatment.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Following definition in the guidance 2010/C 82/01, 2.5, 43. (CT-1), end of trial has been defined as last subject, last visit. Formal discharge of a subject from the trial after review of all data available including laboratory data from the last visit normally occurs after the last visit. Furthermore, for follow-up of TEAEs unresolved at the date of last visit see chapter 13.3.5.2.1.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

150

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

No treatment is planned at the end of the trial. However, patients will be informed, that their original therapy can be continued or they should visit the family doctor to decide upon treatment. In case that, due to participation in the trial health problems occur, which did not exist before participation, the site will conduct a detailed consultation with the patient about therapeutic measures and potential of recovery, observe and take first measures or initiate further treatments.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-09-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-24

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-06-07

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