Trial document




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  DRKS00017294

Trial Description

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Title

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

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Trial Acronym

CLARIFY DROPIZOL®

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URL of the Trial

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Brief Summary in Lay Language

Patients with severe diarrhoea are common in clinical practice. Patients with chemotherapy, radiotherapy, chronic inflammatory bowel disease, ileostoma or short bowel syndrome are particularly affected. Loperamide and opium tincture if other measures have not been effective, are approved for therapy in Germany. Since the end of 2018, the latter has also been available as a finished drug under the name Dropizol, which simplifies its use. Although discontinued opium tincture has been used to treat diarrhea for more than 100 years, there is no data in the scientific literature from studies on the success of clinical use.

The CLARIFY-DROPIZOL study will close this gap. From Q2 2019 to Q1 2020, data will be systematically collected from approximately 250 patients in 15 practices and clinics for a maximum period of 6 months per patient (for oncological patients, until the current therapy regimen changes). Data are systematically collected from patients with severe diarrhoea who are treated with Dropizol. This includes the dosage, the effect of the preparation on diarrhoea, the time to effect, quality of life and side effects. Such data have not yet been collected in clinical practice.

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Brief Summary in Scientific Language

Non-interventional study on utilisation, effectiveness, tolerability, and quality of life in patients with severe diarrhea who are newly treated with Dropizol within the indication of this finished product. The study was designed to be interdisciplinary, and patients with various underlying conditions associated with severe diarrhea can be documented.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017294
  •   2019/05/13
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  •   no
  •   Approved
  •   F-2019-042, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   Severe diarrhea
  •   K52 -  Other noninfective gastroenteritis and colitis
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Interventions/Observational Groups

  •   Patients with servere diarrhea who are newly treated with Dropizol(R)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

• 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

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Secondary Outcome

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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/09/06
  •   250
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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)

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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

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Addresses

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    • GWT-TUD GmbH, Medizin
    • Ms.  Linda  Kottke 
    • Freiberger Str. 33
    • 01067  Dresden
    • Germany
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    • InnoCur Pharma GmbH
    • Mr.  Dr.  Giuseppe  Gianni 
    • Hanauer Landstr. 146
    • 60314  Frankfurt am Main
    • Germany
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    •   +49 (0) 69 400 55 36 00
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    •   info at innocur.de
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    • GWT-TUD GmbH
    • Mr.  Prof. Dr.  David  Pittrow 
    • Freiberger Str. 33
    • 01067  Dresden
    • Germany
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    • GWT-TUD GmbH, Medizin
    • Ms.  Doris  Breiner 
    • Freiberger Str. 33
    • 01067  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • InnoCur Pharma GmbH
    • Hanauer Landstr. 146
    • 60314  Frankfurt am Main
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.