Clinical Trial Results:
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
Summary
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EudraCT number |
2012-003426-24 |
Trial protocol |
DE |
Global end of trial date |
05 Nov 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jul 2022
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First version publication date |
01 Jul 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CTU079G
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Riemser Pharma GmbH
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Sponsor organisation address |
An der Wiek 7, Greifswald - Insel Riems, Germany, 17493
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Public contact |
Medical Science & Operations, RIEMSER Pharma GmbH, +49 38351760, info.germany@esteve.com
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Scientific contact |
Medical Science & Operations, RIEMSER Pharma GmbH, +49 38351760, info.germany@esteve.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Oct 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Oct 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Nov 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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.
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.
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Protection of trial subjects |
This study will be conducted in accordance with the following:
• Federal Ministry of Health (2005). ""Arzneimittelgesetz in der Fassung der Bekanntmachung vom
12. Dezember 2005 (BGBl. I S. 3394), das zuletzt durch Artikel 1 der Verordnung vom 19. Juli
2011 (BGBl. I S. 1398) geändert worden ist"
• 6. Bekanntmachung zur Anzeige von Nebenwirkungen und Arzneimittelmissbrauch nach §63b Abs.
1 bis 8 des Arzneimittelgesetzes (AMG) vom 19.1.2010 ; . [6. Announcement Concerning the Reporting of
Side Effects and Drug Abuse in Accordance with § 63b Abs. 1 to 8 AMG)].
• WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI. Revidierte Deklaration von
Helsinki (Somerset West 2004) [Revised Declaration Somerset West (South Africa, 1996)]
• ICH Topic E 6 (R1) Guideline for Good Clinical Practice (2002)
• General insurance conditions for the clinical trials of medicinal products (subject insurance).
• GCP-Verordnung [GCP-Regulation] – GCP-V: Verordnung über die Anwendung der Guten
Klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Arzneimitteln zur Anwendung
am Menschen vom 9. August 2004
• 3. Bekanntmachung zur klinischen Prüfung von Arzneimitteln am Menschen. Gemeinsame
Bekanntmachung des Bundesinstituts für Arzneimittel und Medizinprodukte und des Paul-Ehrlich-
Instituts vom 10. August 2006
• RIEMSER Arzneimittel AG: Standard Operating Procedures (SOP)
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 529
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Worldwide total number of subjects |
529
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EEA total number of subjects |
529
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
529
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Multi-center study: 18 centers Planned sample size was 265 patients / group, including an expected drop-out rate of 40%. Patients who drop out will not be replaced. At least 56.700 applications of Alvalin® will have to be observed, to reach a sufficient accuracy for the detection of very rare adverse drug reactions. | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
In case of AE, investigator can interrupt or reduce medication. If the same AE occurs again after rechallenging, the medical therapy is reduced or stopped. Individuals who want to discontinue due to lack of efficiency should be encouraged to remain in the study and to attend their study visits. | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Period 1(overall study) - enhancedSafety
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||
Blinding implementation details |
The investigator obtained sealed emergency envelopes containing a letter with the individual treatment (test or reference drug) of the patient. The patient specific envelope was only opened if the medical condition of the patient and the adverse event required this. Reason, signature and date for opening had to be noted on the letter and the project manager at the sponsor had to be informed immediately. Normally, decoding only could have been performed after database closure.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Test Preparation | ||||||||||||||||||||||||||||||
Arm description |
The study medication has to be applied every morning after breakfast. 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. Patients receive basal therapy throughout the study and in addition during 52 weeks an active treatment / placebo therapy which is separated in: • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy The basal therapy in this trial was standardised according to the programme established in the study of Hauner et al. (2004): Basal therapy comprised education, a moderately hypocaloric diet, and an increase in physical activity. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
cathine hydrochloride (Alvalin)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops, liquid
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Routes of administration |
Oral use
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Dosage and administration details |
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.
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Arm title
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Placebo Preparation | ||||||||||||||||||||||||||||||
Arm description |
The study medication / placebo has to be applied every morning after breakfast. 0 mg cathine hydrochloride per day 12 drops of Alvalin® placebo for 52 weeks. Patients receive basal therapy throughout the study and in addition during 52 weeks an active treatment / placebo therapy which is separated in: • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy The basal therapy in this trial was standardised according to the programme established in the study of Hauner et al. (2004): Basal therapy comprised education, a moderately hypocaloric diet, and an increase in physical activity. | ||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops, liquid
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Routes of administration |
Local use
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Dosage and administration details |
0 mg cathine hydrochloride per day 12 drops of Alvalin® placebo for 52 weeks.
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Period 2
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Period 2 title |
Period 2 - eITT
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Test Preparation | ||||||||||||||||||||||||||||||
Arm description |
The study medication has to be applied every morning after breakfast. 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. Patients receive basal therapy throughout the study and in addition during 52 weeks an active treatment / placebo therapy which is separated in: • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy The basal therapy in this trial was standardised according to the programme established in the study of Hauner et al. (2004): Basal therapy comprised education, a moderately hypocaloric diet, and an increase in physical activity. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
cathine hydrochloride (Alvalin)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops, liquid
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Routes of administration |
Oral use
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Dosage and administration details |
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.
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Arm title
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Placebo Preparation | ||||||||||||||||||||||||||||||
Arm description |
The study medication / placebo has to be applied every morning after breakfast. 0 mg cathine hydrochloride per day 12 drops of Alvalin® placebo for 52 weeks. Patients receive basal therapy throughout the study and in addition during 52 weeks an active treatment / placebo therapy which is separated in: • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy The basal therapy in this trial was standardised according to the programme established in the study of Hauner et al. (2004): Basal therapy comprised education, a moderately hypocaloric diet, and an increase in physical activity. | ||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops, liquid
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Routes of administration |
Local use
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Dosage and administration details |
0 mg cathine hydrochloride per day 12 drops of Alvalin® placebo for 52 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Test Preparation
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Reporting group description |
The study medication has to be applied every morning after breakfast. 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. Patients receive basal therapy throughout the study and in addition during 52 weeks an active treatment / placebo therapy which is separated in: • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy The basal therapy in this trial was standardised according to the programme established in the study of Hauner et al. (2004): Basal therapy comprised education, a moderately hypocaloric diet, and an increase in physical activity. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo Preparation
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Reporting group description |
The study medication / placebo has to be applied every morning after breakfast. 0 mg cathine hydrochloride per day 12 drops of Alvalin® placebo for 52 weeks. Patients receive basal therapy throughout the study and in addition during 52 weeks an active treatment / placebo therapy which is separated in: • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy The basal therapy in this trial was standardised according to the programme established in the study of Hauner et al. (2004): Basal therapy comprised education, a moderately hypocaloric diet, and an increase in physical activity. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Test Preparation
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Reporting group description |
The study medication has to be applied every morning after breakfast. 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. Patients receive basal therapy throughout the study and in addition during 52 weeks an active treatment / placebo therapy which is separated in: • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy The basal therapy in this trial was standardised according to the programme established in the study of Hauner et al. (2004): Basal therapy comprised education, a moderately hypocaloric diet, and an increase in physical activity. | ||
Reporting group title |
Placebo Preparation
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Reporting group description |
The study medication / placebo has to be applied every morning after breakfast. 0 mg cathine hydrochloride per day 12 drops of Alvalin® placebo for 52 weeks. Patients receive basal therapy throughout the study and in addition during 52 weeks an active treatment / placebo therapy which is separated in: • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy The basal therapy in this trial was standardised according to the programme established in the study of Hauner et al. (2004): Basal therapy comprised education, a moderately hypocaloric diet, and an increase in physical activity. | ||
Reporting group title |
Test Preparation
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Reporting group description |
The study medication has to be applied every morning after breakfast. 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. Patients receive basal therapy throughout the study and in addition during 52 weeks an active treatment / placebo therapy which is separated in: • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy The basal therapy in this trial was standardised according to the programme established in the study of Hauner et al. (2004): Basal therapy comprised education, a moderately hypocaloric diet, and an increase in physical activity. | ||
Reporting group title |
Placebo Preparation
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Reporting group description |
The study medication / placebo has to be applied every morning after breakfast. 0 mg cathine hydrochloride per day 12 drops of Alvalin® placebo for 52 weeks. Patients receive basal therapy throughout the study and in addition during 52 weeks an active treatment / placebo therapy which is separated in: • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy • 08 weeks of basal therapy only • 12 weeks of active treatment or placebo therapy The basal therapy in this trial was standardised according to the programme established in the study of Hauner et al. (2004): Basal therapy comprised education, a moderately hypocaloric diet, and an increase in physical activity. |
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End point title |
Change of weight in total | ||||||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
52 weeks
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Statistical analysis title |
Hypothesis 1 (eITT) | ||||||||||||
Statistical analysis description |
A two sided t-test was used for analysis of the reduction of body weight with a global α level of 0.05. Because there were two hypotheses, the α level for H1 is 0.025 (one sample t-test) and for H2 α is also 0.025 (two sample t-test)
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Comparison groups |
Placebo Preparation v Test Preparation
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Number of subjects included in analysis |
496
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
< 0.0001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Percentage of patients with weight loss >10% | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
52 weeks
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No statistical analyses for this end point |
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End point title |
Percentage of patients with weight loss > 5 % | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
52 weeks
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No statistical analyses for this end point |
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End point title |
Weight loss during the trial(V1-V13) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
52 weeks
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No statistical analyses for this end point |
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End point title |
Change in waist circumference (WC) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
52 weeks
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No statistical analyses for this end point |
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End point title |
Change in waist-hip ratio (WHR) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
52 weeks
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No statistical analyses for this end point |
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End point title |
Change in BMI | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
52 weeks
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No statistical analyses for this end point |
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End point title |
Phisicians assessment of efficacy | ||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
52 weeks
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No statistical analyses for this end point |
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End point title |
Patient's assessment of efficacy | ||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
52 weeks
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were assessed during the 52 weeks of study, additionally at follow-up visit 1 (3 months after end of treatment) and follow-up visit 2 (12 months after end of treatment).
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Adverse event reporting additional description |
15 randomised patients (2.3 %) had no intake of study medication and therefore 514 patients (79.9 %) were valid for the safety analysis.
In 349/514 patients (67.9%) 959 AEs occurred: in 182 patients (52.1%) treated with Alvalin®, and in 167 patients (47.9%) receiving placebo.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
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Reporting groups
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Reporting group title |
Safety Placebo Preparation
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Reporting group description |
All persons with documented intake of trial medication in the course of the clinical trial were valid for the safety analysis. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Safety Test preparation
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Reporting group description |
All persons with documented intake of trial medication in the course of the clinical trial were valid for the safety analysis. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |