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

• Conditions: Severe diarrhea; K52; Other noninfective gastroenteritis and colitis

• Registration Number: DRKS00017294
• Lead Sponsor: GWT-TUD GmbH, Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Study Completion: 2021-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 62

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

• 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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