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NCT03076411
Pepsin in Patients With Functional Dyspepsia
trial testing Pepsin in Functional Gastrointestinal Disorders in 97 participants. Completed in 16 June 2015.
19 December 2013
Quick facts
| Lead sponsor | Nordmark Arzneimittel GmbH & Co. KG |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 97 |
| Start date | 11 January 2012 |
| Primary completion | 19 December 2013 |
| Estimated completion | 16 June 2015 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Pepsin — full drug profile →
Conditions studied
- Functional Gastrointestinal Disorders — all drugs for Functional Gastrointestinal Disorders →
- Abdominal Pain — all drugs for Abdominal Pain →
- Dyspepsia — all drugs for Dyspepsia →
- Nausea — all drugs for Nausea →
Sponsor
Nordmark Arzneimittel GmbH & Co. KG — full company profile →
Who can join
Adults 18 to 75, any sex, with Functional Gastrointestinal Disorders or Abdominal Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A non-interventional, observational study of a fixed combination of pepsin and amino acid hydrochloride in patients with functional dyspepsia.
Forssmann K, Meier L, Uehleke B, Breuer C, et al · · 2017 · cited 7× · PMID 29178842 · DOI 10.1186/s12876-017-0675-9
Verify or expand the search:
- PubMed search for NCT03076411
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03076411 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nordmark Arzneimittel GmbH & Co. KG
- Last refreshed: 10 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03076411.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing