Functional Gastrointestinal DisordersNCT03076411
Pepsin in Patients With Functional Dyspepsia
An observational study of Functional Gastrointestinal Disorders and Abdominal Pain, run by Nordmark Arzneimittel GmbH & Co. KG at 1 site in Germany.
Trial summary
This non-interventional, observational study investigates the course of symptoms in patients with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid hydrochloride over a period of approximately 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Gastrointestinal Disorders, Abdominal Pain, Dyspepsia
- What is being tested?
- Pepsin
- How many people
- 97 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jan 2012to 16 Jun 2015
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presented with acute and chronic gastrointestinal symptoms, it was decided on the basis of their history, previous findings (diagnostic endoscopy and imaging, if available) and findings on physical examination whether they could participate in the postmarketing surveillance.
Who may be able to join
- Patients with dyspepsia
- Women and men aged between 18 and 75
Who cannot join
- Unwilling to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-interventional, Observational Study With a Fixed Combination of Pepsin and Amino Acid Hydrochloride in Patients With Functional Dyspepsia
This non-interventional, observational study investigates the course of symptoms in patients with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid hydrochloride over a period of approximately 6 weeks. The change of the Gastrointestinal Symptom Score (GIS©) was the primary parameter for the assessment of efficacy and was performed at baseline, after 3 and 6 weeks of treatment respectively. Safety measures included recording of AEs and physical examination as well as measurement of vital signs. The aim was to observe 100 patients during the course of this non-interventional study.
- Conditions
- Functional Gastrointestinal Disorders, Abdominal Pain, Dyspepsia, Nausea, Vomiting, Flatulence
- Being tested
- Pepsin
- Keywords
- Dyspepsia, Observational trial, Enzyme therapy, Pepsin
- Medical subject headings
- Gastrointestinal Diseases, Abdominal Pain, Dyspepsia, Nausea, Vomiting, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PepsinDrug
Also called amino acid hydrochloride
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Score (GIS)
This is a third party assessment form.
Measured: 6 weeks
Secondary outcomes (4)
Tolerability assessed by Adverse Events
Adverse Events
Measured: 6 weeks
Subjective assessment of efficacy (4 point Likert scale)
Patient overall assessment (very good, good, moderate, no effect)
Measured: 6 weeks
Subjective assessment of feasibility of use (4 point Likert scale)
Patient overall assessment (very good, good, moderate, no effect)
Measured: 6 weeks
Symptomatology
Nepean Dyspepsia Index (NDI) modified
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start11 Jan 2012
- Primary completion19 Dec 2013
- Study completion16 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordmark Arzneimittel GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSupport GmbH, MWI Medizinisches Wirtschaftsinstitut GmbH, das forschungsdock
- Responsible party
- Sponsor
- Investigators
- Kristin Forssmann, MD, Study director, Nordmark Arzneimittel GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076411
- Sponsor's protocol ID
- NM-Efo-401
- Status last verified
- Mar 2017
- First submitted
- 19 Oct 2016
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forssmann K, Meier L, Uehleke B, Breuer C, Stange R. A non-interventional, observational study of a fixed combination of pepsin and amino acid hydrochloride in patients with functional dyspepsia. BMC Gastroenterol. 2017 Nov 25;17(1):123. doi: 10.1186/s12876-017-0675-9.
PubMed 29178842
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Observational Study With a Fixed Combination of Pepsin and Amino Acid Hydrochloride in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT03076411
- Acronym / sponsor ID
- NM-Efo-401
- Conditions
- Functional Gastrointestinal Disorders, Abdominal Pain, Dyspepsia, Nausea, Vomiting, Flatulence
- Keywords
- Dyspepsia, Observational trial, Enzyme therapy, Pepsin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Nordmark Arzneimittel GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- ClinSupport GmbH, MWI Medizinisches Wirtschaftsinstitut GmbH, das forschungsdock
- Study start
- 11 Jan 2012 (actual)
- Primary completion
- 19 Dec 2013 (actual)
- Study completion
- 16 Jun 2015 (actual)
- First posted
- 10 Mar 2017 (actual)
- 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 non-interventional, observational study investigates the course of symptoms in patients with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid hydrochloride over a period of approximately 6 weeks. The change of the Gastrointestinal Symptom Score (GIS©) was the primary parameter for the assessment of efficacy and was performed at baseline, after 3 and 6 weeks of treatment respectively. Safety measures included recording of AEs and physical examination as well as measurement of vital signs. The aim was to observe 100 patients during the course of this non-interventional study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented with acute and chronic gastrointestinal symptoms, it was decided on the basis of their history, previous findings (diagnostic endoscopy and imaging, if available) and findings on physical examination whether they could participate in the postmarketing surveillance.
Key inclusion criteria (2 listed)
- Patients with dyspepsia
- Women and men aged between 18 and 75
Key exclusion criteria (1 listed)
- Unwilling to consent
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 |
|---|---|---|
| PepsinAlso: amino acid hydrochloride | Drug | – |
Primary outcome
Gastrointestinal Symptom Score (GIS)
Time frame: 6 weeks
This is a third party assessment form.
4 secondary outcomes
Tolerability assessed by Adverse Events
Time frame: 6 weeks
Subjective assessment of efficacy (4 point Likert scale)
Time frame: 6 weeks
Subjective assessment of feasibility of use (4 point Likert scale)
Time frame: 6 weeks
Symptomatology
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Derived from this study: PubMed 29178842Forssmann K, Meier L, Uehleke B, Breuer C, Stange R. A non-interventional, observational study of a fixed combination of pepsin and amino acid hydrochloride in patients with functional dyspepsia. BMC Gastroenterol. 2017 Nov 25;17(1):123. doi: 10.1186/s12876-017-0675-9.
- Individual participant dataSharing planned: No
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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.
Kristin Forssmann, MD study director
Nordmark Arzneimittel GmbH & Co. KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders and Abdominal Pain, run by Nordmark Arzneimittel GmbH & Co. KG at 1 site in Germany.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gastrointestinal Symptom Score (GIS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03076411, which also lists 1 linked publication.
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 10 Mar 2017.