PROSPECTIVE OBSERVATIONAL STUDY ON THE UTILISATION AND TREATMENT RESULTS OF PATIENTS NEWLY TREATED WITH DROPIZOL® (OPIUM TINCTURE) UNDER CONDITIONS OF EVERYDAY PRACTICE

PROSPECTIVE OBSERVATIONAL STUDY ON THE UTILISATION AND TREATMENT RESULTS OF PATIENTS NEWLY TREATED WITH DROPIZOL® (OPIUM TINCTURE) UNDER CONDITIONS OF EVERYDAY PRACTICE - CLARIFY DROPIZOL®

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017294

Enrollment

Registered

2019-05-13

Start date

2019-09-06

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe diarrhea K52

Interventions

Group 1: Patients with servere diarrhea who are newly treated with Dropizol(R)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Severe diarrhoea, e.g. diarrhoea caused by cytostatic drugs, radiation or neuroendocrine tumours, if the application of other antidiarrheal drugs has not produced a sufficient effect. • Written consent before the first documentation. • Newly treated with Dropizol® within the provisions of the Summary of Product Characteristics (SPC)

Exclusion criteria

Exclusion criteria: • Contraindications as described in the Summary of Product Characteristics • Lack of cognitive and linguistic ability to participate in the study • Patient (probably) not available for follow-up period (up to 6 months) • Pregnancy

Design outcomes

Primary

Measure	Time frame
• Change in number of stools per day at approximately 10 days compared to baseline (treatment initiation) • Ileostomy patients: change in excretion quantity (ml) in bag at approximately 10days compared to baseline (treatment initiation) • Dropizol® dosage at approximately 10-14 days compared to baseline	—

Secondary

Measure	Time frame
Change in number of stools per day at 6 months (or end of observation) compared to baseline (treatment initiation) • In ileostomy patients: change in excretion quantity (ml) in bag at end of observation compared to baseline o at reversal of ileostoma o at introduction of new line of chemotherapy (adjuvant therapy) o in any case no later than 6 months • Dropizol® dosage at 6 months (or end of observation) compared to baseline (treatment initiation) • Time to effect (= days of Dropizol® treatment leading to normalized frequency of stools per day) • Dosing pattern (number of Dropizol® doses per day) • In oncological patients only: STIDAT total score at 6 months (or end of observation) compared to baseline (treatment initiation) • QoL (by EQ-5D VAS) at 6 months (or end of observation) compared to baseline (treatment initiation) • QLQ-C30 at 6 months (or end of observation) compared to baseline (treatment initiation)	—

Measure

Time frame

Change in number of stools per day at 6 months (or end of observation) compared to baseline (treatment initiation) • In ileostomy patients: change in excretion quantity (ml) in bag at end of observation compared to baseline o at reversal of ileostoma o at introduction of new line of chemotherapy (adjuvant therapy) o in any case no later than 6 months • Dropizol® dosage at 6 months (or end of observation) compared to baseline (treatment initiation) • Time to effect (= days of Dropizol® treatment leading to normalized frequency of stools per day) • Dosing pattern (number of Dropizol® doses per day) • In oncological patients only: STIDAT total score at 6 months (or end of observation) compared to baseline (treatment initiation) • QoL (by EQ-5D VAS) at 6 months (or end of observation) compared to baseline (treatment initiation) • QLQ-C30 at 6 months (or end of observation) compared to baseline (treatment initiation)

—

Countries

Germany

Contacts

Public ContactRomy Wagner

GWT-TUD GmbH, Medizin

romy.wagner@g-wt.de0351 259 33186

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026