Trial Description

DRKS-ID: DRKS00005184
Date of Registration in DRKS: 2013/08/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
PLEASE NOTE: This trial has been registered retrospectively.
Trial Description
Title
A multicentre, double-blind, placebo-controlled clinical trial to assess efficacy and
safety of Alvalin® (cathine hydrochloride) vs. placebo in 265 obese patients/group
with a body mass index (BMI) between 30 and 45 kg/m2
Trial Acronym
CTU 079G
URL of the trial
[---]*
Brief Summary in Lay Language
Indication:
Support of weight reduction in diet-related obesity in the context of a
multidisciplinary weight loss programme.
Background:
Obesity is formally defined as a body mass index (BMI) equal or greater than 30
kg/m². The BMI is a simple anthropometric measure of body weight relative to
body height. Obesity is known as a risk factor for diabetes type 2, hypertension,
cardiovascular disease like coronary heart disease and stroke, deep vein
thrombosis, sleep apnoea, gall stone trouble, some kinds of cancer (e.g. breast
cancer and bowel cancer) and arthrosis.
Alvalin® has been used to achieve weight reduction in diet-related obesity for a
long time. The compound cathine (D-norpseudoephedrin hydrochloride) is a drug
with an indirect sympathomimetic effect activating the sympathetic nervous
system by increasing the amount of messenger substances involved in signal
transmission in the central nervous system. A direct suppressing effect on the
brain’s appetite-regulating centre is assumed.
Participants:
Patients with diet-related obesity with a BMI of 30 to 45 kg/m².
Patients will be grouped to either group 1 or 2 at random. The study medication
has to be applied every morning after breakfast:
Treatment group 1: 0 mg cathine hydrochloride per day, i.e
12 drops of Alvalin® placebo for thrice 12 weeks separated by 2 periods of eight
weeks with basal therapy only
Treatment group 2: 32 mg cathine hydrochloride per day, i.e.
12 drops of Alvalin® intermittent for thrice 12 weeks separated by 2 periods of
eight weeks with basal therapy only
Objective:
Evaluation of the efficacy and safety of 32 mg of Alvalin® compared to placebo
given intermittently over 52 weeks (three treatment periods interrupted by two
periods with basal therapy only) in the treatment of diet-related obesity in
patients with a BMI of 30 to 45 kg/m².
Page 1 of 8
DRKS-ID: DRKS00005184
Date of Registration in DRKS: 2013/08/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Brief Summary in Scientific Language
The rationale of this study is to investigate the efficacy and safety of intermittent
adjunct administration of Alvalin® in the treatment of obesity using a daily dose
of 32 mg cathine hydrochloride. The suggested dosage was derived from a
recently finished dose-finding study.
Organizational Data
DRKS-ID: DRKS00005184
Date of Registration in DRKS: 2013/08/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: 5545/12 , Ethik-Kommission der Fakultät für Medizin
der Technischen Universität München
Secondary IDs
Universal Trial Number (UTN): U1111-1146-2814
EudraCT-No.
(for studies acc. to Drug Law): 2012-003426-24
Health condition or Problem studied
Free text: diet-related obesity
ICD10: E66.0 - Obesity due to excess calories
Interventions/Observational Groups
Arm 1: Treatment group 1: 0 mg cathine hydrochloride per day, i.e.
12 drops of Alvalin® placebo for thrice 12 weeks separated by 2 periods of
eight weeks with basal therapy only
Arm 2: Treatment group 2: 32 mg cathine hydrochloride per day, i.e.
12 drops of Alvalin® intermittent for thrice 12 weeks separated by 2 periods of
eight weeks with basal therapy only
Characteristics
Study Type: Interventional
Study Type Non-Interventional: [---]*
Page 2 of 8
DRKS-ID: DRKS00005184
Date of Registration in DRKS: 2013/08/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: [---]*
Who is blinded: patient/subject, investigator/therapist
Control: Placebo
Purpose: Treatment
Assignment: Parallel
Phase: III
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): No
Primary Outcome
Primary endpoint is the weight reduction of at least 10% overall in the treatment
group with at least 5% greater weight reduction than in the placebo group) after
52 weeks of treatment.
Following the EMA Guideline on Clinical Evaluation of Medicinal Products used in
Weight Control [Guideline on Weight Control (2007)], administering Alvalin®, a
weight reduction of at least 10% compared to baseline and a superiority in weight
reduction of at least 5% compared to placebo after a period of 12 months of
therapy are necessary to fulfil the primary criterion.
Secondary Outcome
SECONDARY ENDPOINTS (efficacy)
•percentage of patients with weight loss > 5 %
•percentage of patients with weight loss > 10 %
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DRKS-ID: DRKS00005184
Date of Registration in DRKS: 2013/08/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
uric acid, AST , ALT, -GT , serum-creatinine, C-reactive protein (CRP).
•overall assessment of tolerability by physician and by patient
Countries of recruitment
DE Germany
Locations of Recruitment
other Clinical Research Hamburg GmbH, Hamburg
other Klinische Forschung Dresden GmbH, Dresden
Medical Center Klinikum rechts der Isar, München
University Medical Center Charité, Berlin
other Klinische Forschung Berlin-Buch GmbH, Berlin
other Klinische Forschung Schwerin GmbH, Schwerin
University Medical Center Medizinische Klinik III, Leipzig
other Adipositaszentrum, Oberhausen
Doctor's Practice Aachen
Doctor's Practice Aachen
Doctor's Practice Aachen
Doctor's Practice Aachen
Doctor's Practice Berlin
other Facharztzentrum, Düsseldorf
Doctor's Practice Essen
other Gesundheitsschule, Aachen
Recruitment
Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2013/03/14
Target Sample Size: 530
Monocenter/Multicenter trial: Multicenter trial
National/International: National
Inclusion Criteria
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DRKS-ID: DRKS00005184
Date of Registration in DRKS: 2013/08/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 65 Years
Additional Inclusion Criteria
Inclusion Criteria:
Specific:
•male and female patients, aged 18-65 years
•caucasian origin
•diet-related obesity diagnosed by BMI of 30 to 45 kg/m²
•blood pressure after 5 min sitting at rest : <160/<90 mmHg
Exclusion criteria
Exclusion criteria:
Specific:
•
weight gain or loss of > 3 kg, use of a very-low-calorie diet, or
participation in a formal weight loss program within the past three months
•
previous bariatric surgery
•
cardiovascular diseases e.g.:
o
history of stroke
o
myocardial infarction
o
life-threatening arrhythmia
o
coronary revascularization
o
angina pectoris
o
heart failure: NYHA classification stage 3 and 4
o
known clinical relevant coronary heart disease
o
known clinical relevant reduction of left ventricular function
o
serious arrhythmia
o
inflammatory heart disease
o
valvular heart disease
o
transient ischemic attack (TIA)
o
peripheral arterial disease
o
cerebrovascular disease
•
Neurologic
o
Previous or current mental diseases including anorexia nervosa and
Page 5 of 8
DRKS-ID: DRKS00005184
Date of Registration in DRKS: 2013/08/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
depression
o
current Hospital Anxiety and Depression Scale (HADS) score >=11
o
recent (previous 6 months) suicide attempt or ideation with some intent
to act
•
phaeochromocytoma
•
history of narrow angle glaucoma
•
history of any cancer
•
untreated hypothyroidism : TSH >1.5 x upper limit of normal (ULN), signs
or symptoms of hypothyroidism, use of thyroid hormone treatment that was not
stable for at least three months
•
hyperthyroidism
•
known history of pulmonary hypertension
•
diabetes type 1
•
cushing’s syndrome or intake of glucocorticoids if the duration of the
therapy surpasses the duration of an acute short term therapy
•
impaired kidney function: serum creatinine levels >1.4 mg/dL for women,
>1.5 mg/dL for men
•
hepatic impairment: clinically significantl AST or ALT or gammaglutamyltransferase >3 x ULN
•
insomnia
•
cut off limit in patients with coexisting risk factors like hyperlipidaemia
and type 2 diabetes mellitus
o
fasting plasma glucose > 200 mg/dL (11.1 mmol/L)
o
HbA1c > 8,5 % (69,4 mmol/mol)
o
triglycerides > 800 mg/dL (9.14 mmol/L)
•
other severe systemic concomitant diseases
•
intake of drugs which have an impact on cathine action, tendency to
misuse of medication or alcohol dependency
•
known intolerance to cathine or other ingredients of the test/reference
drug
•
high caffeine consumption (> 6 cups / day) or intake of caffeine
–containing soft drinks > 1,5L
General:
•
female patients only: pregnancy or lactation, insufficient contraception
•
suspected/confirmed drug/alcohol addiction and abuse
•
current or previous participation in another clinical trial within 12 weeks
preceding the start of the study
•
legal incapacity and/or other circumstances rendering the patient unable
to understand the nature, scope and possible consequences of the study
•
unreliability or lack of cooperation and compliance
Addresses
Primary Sponsor
RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald
Germany
Telephone: [---]*
Fax: [---]*
Page 6 of 8
DRKS-ID: DRKS00005184
Date of Registration in DRKS: 2013/08/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Primary Sponsor
RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald
Germany
Telephone: [---]*
Fax: [---]*
E-mail: schroederd at riemser.com
URL: www.riemser.com
Contact for Scientific Queries
RIEMSER Pharma GmbH
Mr. Dr. Dietmar Schröder
An der Wiek 7
17493 Greifswald
Germany
Telephone: 038351 76 121
Fax: [---]*
E-mail: schroederd at riemser.com
URL: www.riemser.com
Contact for Public Queries
RIEMSER Pharma GmbH
Mr. Dr. Dietmar Schröder
An der Wiek 7
17493 Greifswald
Germany
Telephone: 038351 76 121
Fax: [---]*
E-mail: schroederd at riemser.com
URL: www.riemser.com
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
RIEMSER Pharma GmbH
Mr. Dr. Dietmar Schröder
An der Wiek 7
17493 Greifswald
Germany
Telephone: [---]*
Fax: [---]*
Page 7 of 8
DRKS-ID: DRKS00005184
Date of Registration in DRKS: 2013/08/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Commercial (pharmaceutical industry, medical engineering industry, etc.)
RIEMSER Pharma GmbH
Mr. Dr. Dietmar Schröder
An der Wiek 7
17493 Greifswald
Germany
Telephone: [---]*
Fax: [---]*
E-mail: schroederd at riemser.com
URL: www.riemser.com
Status
Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*
Trial Publications, Results and other documents
* This entry means the parameter is not applicable or has not been set.
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