Samsca PMS: Samsca Post Marketing Surveillance Study

• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02722863
• Collaborator: (none)
• Enrollment: 908
• Locations: 4
• Actual Duration (Months): 47.2
• Patients Per Site: 227
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011~31Aug2017). Each subject will be observed at least for 4 days during the surveillance period.

Condition or Disease	Intervention/Treatment	Phase
Hypervolemic and Euvolemic Hyponatremia

Detailed Description

This study will be conducted as a prospective, single-arm, multicenter study. Findings on examination, diagnosis, opinions and observations implemented as per general medical practice during the observational period will be documented in the case report forms by the investigators or responsible staffs at the institution since the surveillance is an observational study.

Study Design

• Study Type: Observational
• Actual Enrollment: 908 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Post Marketing Surveillance Study of Safety and Efficacy of Samsca® Tablets Under the "New Drug Re-Examination"
• Actual Study Start Date: Jul 9, 2013
• Actual Primary Completion Date: Jun 15, 2017
• Actual Study Completion Date: Jun 15, 2017

Outcome Measures

Primary Outcome Measures

1. Safety Measure [4days]

   Adverse Events (AEs)

Secondary Outcome Measures

1. Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit [Follow-up at least 4 days after first Samsca® dose]

   In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :

1. Patients who have hyponatremia in euvolemic or hypervolemic states, defined as serum sodium level < 125 mEq/L or hyponatremia that is symptomatic and has resisted correction with fluid restriction

2. Patients who are prescribed Samsca® treatment as per investigator's medical judgment

3. Patients who gave written authorization to use their personal and health data

4. Patients starting Samsca® treatment after agreement is in place Investigators will refer to the product market authorization (label) for inclusion criteria.

Exclusion Criteria:

• Subjects presenting with any of the following will not be included in the study:

1. Patients who have been treated with Samsca®

2. Patients with known or suspected hypersensitivity to tolvaptan or to any ingredient of the drug

3. Patients requiring urgent intervention to raise serum sodium acutely.

4. Inability of the patient to sense or appropriately respond to thirst.

5. Hypovolemic hyponatremia

6. Concomitant use of strong CYP3A inhibitors

7. Anuric patients

8. Volume depletion patients

9. Hypernatremia patients

10. Women who are pregnant or possibly pregnant and lactation

11. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Investigators will refer to the product market authorization (label) for exclusion criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bong Seng Hospital	Busan		Korea, Republic of	47889
2	Daegu Catholic University Medical Center	Daegu		Korea, Republic of	42472
3	Chungnam National University Hospital	Daejeon		Korea, Republic of	35015
4	Chung-Ang University Hospital	Seoul		Korea, Republic of	06973

Sponsors and Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 20, 2016

More Information

Publications

None provided.

• Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02722863
• Other Study ID Numbers: 156-KOA-1201n
• First Posted: Mar 30, 2016
• Last Update Posted: Mar 6, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Hyponatremia

Study Results

Participant Flow

Arm/Group Title	Samsca
Arm/Group Description	Patients who have hyponatremia in euvolemic or hypervolemic states, defined as serum sodium level < 125 mEq/L or hyponatremia that is symptomatic and has resisted correction with fluid restriction. Patients who are prescribed Samsca® treatment as per investigator's medical judgment Patients who gave written authorization to use their personal and health data Patients starting Samsca® treatment after agreement is in place
Period Title: Overall Study
STARTED	908
COMPLETED	908
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Safety Set
Arm/Group Description	all patients who received Samsca® tablets at least once and had at least one post-treatment assessment during the study in approved indication and dosage regimen
Overall Participants	668
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	154 23.1%
>=65 years	514 76.9%
Sex: Female, Male (Count of Participants)
Female	326 48.8%
Male	342 51.2%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Safety Measure
Description	Adverse Events (AEs)
Time Frame	4days

Outcome Measure Data

Analysis Population Description

Safety analysis set was defined as all patients who received Samsca® tablets at least once and had at least one post-treatment assessment during the study in approved indication and dosage regimen.

Arm/Group Title	Safety Set
Arm/Group Description	a safety evaluation was conducted on 668 patients out of 908 patients' collected survey
Measure Participants	668
Number (95% Confidence Interval) [percentage of AE]	17.37

2. Secondary Outcome

Title	Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit
Description	In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit
Time Frame	Follow-up at least 4 days after first Samsca® dose

Outcome Measure Data

Analysis Population Description

the efficacy set is patients who received Samsca® tablets for at least 4 consecutive days and had the data on serum sodium level(mEq/L) on the 4th day of receiving Samsca® tablets.

Arm/Group Title	Efficacy Set
Arm/Group Description	patients who received Samsca® tablets for at least 4 consecutive days and had the data on serum sodium level(mEq/L) on the 4th day of receiving Samsca® tablets.
Measure Participants	452
Firtst visit	123.78 (4.81)
4th day	134.83 (5.69)

Adverse Events

Time Frame	up to 4 days.
Arm/Group Title	Safety Set
Arm/Group Description	a safety evaluation was conducted on 668 patients out of 908 patients' collected survey
All Cause Mortality
	Safety Set
	Affected / at Risk (%)	# Events
Total	6/668 (0.9%)
Serious Adverse Events
	Safety Set
	Affected / at Risk (%)	# Events
Total	10/668 (1.5%)
Cardiac disorders
Heart valve disorders	1/668 (0.1%)	1
General disorders
Asthenia	1/668 (0.1%)	1
Condition aggravated	1/668 (0.1%)	1
Fever	1/668 (0.1%)	1
Hepatobiliary disorders
Bilirubinaemia	1/668 (0.1%)	1
Psychiatric disorders
Delirium	1/668 (0.1%)	1
Renal and urinary disorders
Azotaemia	2/668 (0.3%)	2
Pyelonephritis	1/668 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/668 (0.1%)	1
Pulmonary oedema	1/668 (0.1%)	1
Dyspnoea	1/668 (0.1%)	1
Respiratory insufficiency	1/668 (0.1%)	1
Vascular disorders
Cardiac failure	1/668 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Safety Set
	Affected / at Risk (%)	# Events
Total	110/668 (16.5%)
Blood and lymphatic system disorders
Anaemia	2/668 (0.3%)	2
Thrombocytopenia	2/668 (0.3%)	2
Leucopenia	1/668 (0.1%)	1
Cardiac disorders
Palpitation	2/668 (0.3%)	2
Tachycardia ventricular	2/668 (0.3%)	2
Tachycardia	1/668 (0.1%)	1
Myocardial ischaemia	1/668 (0.1%)	1
Gastrointestinal disorders
Constipation	43/668 (6.4%)	55
Diarrhoea	16/668 (2.4%)	16
Nausea	10/668 (1.5%)	11
Vomiting	8/668 (1.2%)	8
Abdominal pain	6/668 (0.9%)	6
Indigestion	4/668 (0.6%)	5
Mouth dry	4/668 (0.6%)	5
Mucosal ulceration	1/668 (0.1%)	1
Haematemesis	1/668 (0.1%)	1
Tongue discolouration	1/668 (0.1%)	1
General disorders
Fever	8/668 (1.2%)	8
Back pain	3/668 (0.4%)	3
Pain	3/668 (0.4%)	3
Leg pain	2/668 (0.3%)	2
Oedema peripheral	2/668 (0.3%)	2
Asthenia	1/668 (0.1%)	1
Hyperpyrexia	1/668 (0.1%)	1
Fatigue	1/668 (0.1%)	1
Medicine ineffective	1/668 (0.1%)	1
Hepatobiliary disorders
ALT increased	1/668 (0.1%)	1
AST increased	1/668 (0.1%)	1
Immune system disorders
Infection	2/668 (0.3%)	2
Investigations
Post-operative haemorrhage	1/668 (0.1%)	1
Decubitus ulcer	1/668 (0.1%)	1
Metabolism and nutrition disorders
Hyperkalaemia	5/668 (0.7%)	5
Hypokalaemia	5/668 (0.7%)	5
Hypocalcaemia	4/668 (0.6%)	4
Thirst	3/668 (0.4%)	3
Weight decrease	3/668 (0.4%)	3
Hypernatraemia	3/668 (0.4%)	3
Hyponatraemia	2/668 (0.3%)	2
Hyperphosphataemia	2/668 (0.3%)	2
Hyperglycaemia	1/668 (0.1%)	1
Polydipsia	1/668 (0.1%)	1
Acidosis	1/668 (0.1%)	1
Hypophosphataemia	1/668 (0.1%)	1
Weight increase	1/668 (0.1%)	1
Musculoskeletal and connective tissue disorders
Skeletal pain	3/668 (0.4%)	3
Arthralgia	2/668 (0.3%)	2
Myalgia	2/668 (0.3%)	2
Nervous system disorders
Headache	6/668 (0.9%)	6
Dizziness	4/668 (0.6%)	4
Hyperkinesia	1/668 (0.1%)	1
Psychiatric disorders
Insomnia	4/668 (0.6%)	4
Delirium	3/668 (0.4%)	3
Anorexia	4/668 (0.6%)	4
Anxiety	2/668 (0.3%)	2
Renal and urinary disorders
Azotaemia	5/668 (0.7%)	5
Pyelonephritis	1/668 (0.1%)	1
Urinary tract infection	2/668 (0.3%)	2
Cystitis	1/668 (0.1%)	1
Dysuria	1/668 (0.1%)	1
Urinary incontinence	1/668 (0.1%)	1
Oliguria	1/668 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	4/668 (0.6%)	4
Coughing	3/668 (0.4%)	3
Pneumonia	1/668 (0.1%)	1
Sputum increased	1/668 (0.1%)	1
Pharyngitis	1/668 (0.1%)	1
Respiratory disorder	1/668 (0.1%)	1
Skin and subcutaneous tissue disorders
Pruritus	5/668 (0.7%)	5
Rash maculo-papular	1/668 (0.1%)	1
Skin disorder	1/668 (0.1%)	1
Rash erythematous	1/668 (0.1%)	1
Vascular disorders
Hypotension	8/668 (1.2%)	8
Hypertension	4/668 (0.6%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.