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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02573077
Other study ID # OPEL/2014/067
Secondary ID
Status Completed
Phase
First received October 6, 2015
Last updated April 3, 2018
Start date October 2015
Est. completion date December 13, 2017

Study information

Verified date April 2018
Source Otsuka Pharmaceutical Europe Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational, prospective, non-interventional study will include cancer patients who need a treatment for hyponatraemia secondary to SIADH. Patients will be prescribed treatment(s) according with the clinical practice regardless of the patient participation in the study. The purpose of this NIS is to collect additional scientific and clinical information that can help in describing the characteristics of cancer patients with hyponatraemia secondary to SIADH, the current management of hyponatremia, the therapies to keep under control serum [Na+] and the guidelines for the management of this population in Italy.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date December 13, 2017
Est. primary completion date December 13, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age >= 18 years;

2. Male or female patients with a cytologically or histologically documented cancer diagnosis;

3. Moderate to severe hyponatremia: Na+ level cut off: [Na+] < 130 mmol/L;

4. Physician diagnosed Moderate to severe hyponatremia secondary to SIADH (clinical or laboratory determined as per normal routine practice of treating physician);

5. No use of diuretic agents within the week prior to evaluation;

6. Willingness to participate in the study; subjects must give their written consent to participate.

Exclusion Criteria:

1. Use of concomitant medications including demeclocycline and/or urea, by themselves or in combination with fluid restriction;

2. Subject is currently participating in a clinical trial in which the investigational medicinal product aims to treat the causes or symptoms of hyponatremia;

3. Life expectancy is lower than 3 months.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Otsuka Pharmaceutical Europe Ltd

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in serum [Na+] Change in serum [Na+] from the baseline visit to the end of the first month or sixth month of the observational period or until earlier discontinuation from the study 1 month and 6 months
Secondary EQ-5D to measure quality of life Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months.
EQ-5D EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
From baseline up to 6 months
Secondary EORTC QLQ-C30 to measure quality of life Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months.
EORTC QLC-C30: European Organisation for Research and Treatment of Cancer (EORTC) Study Group on Quality of Life has developed the EORTC QLQ-C30 questionnaire consisting in a modular system for assessing the quality of life of cancer patients in clinical research.
From baseline up to 6 months
Secondary ECOG PS to assess progress of the disease Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months.
The Eastern Cooperative Oncology Group (ECOG) performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate (oncology) treatment and prognosis.
From baseline up to 6 months
Secondary Measure of cognitive impairment: mini-mental state examination (MMSE) Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months.
The mini-mental state examination (MMSE) or Folstein test is a sensitive, valid and reliable 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.
From baseline up to 6 months
Secondary Time to chemotherapy (days) Longitudinal (up to 6 months)
Secondary Length of stay (days) Longitudinal (up to 6 months)
Secondary Readmission (number of readmissions) will be used to evaluate rate of readmissions among this population Longitudinal (up to 6 months)
Secondary Survival status (%) Will be used to evaluate overall survival (%) among this population after 6 months. 6 months
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