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Efficacy and Safety of IQP-VV-102 in Weight Management

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ClinicalTrials.gov Identifier: NCT01681069
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : November 6, 2015
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
InQpharm Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Obesity
Overweight
Interventions Dietary Supplement: IQP-VV-102
Other: Placebo
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IQP-VV-102 Placebo
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2 tablets twice a day

IQP-VV-102

2 tablets twice a day

Placebo

Period Title: Overall Study
Started 60 60
Full Analysis Set (FAS) 57 60
Completed 55 [1] 53 [1]
Not Completed 5 7
Reason Not Completed
Withdrawal by Subject             4             5
Protocol Violation             1             1
Adverse Event             0             1
[1]
Valid Case Analysis Set (VAS)
Arm/Group Title IQP-VV-102 Placebo Total
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2 tablets twice a day

IQP-VV-102

2 tablets twice a day

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 57 60 117
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*Only 117 out of 118 subjects included in the intention-to-treat population as one subject was lost to follow-up after visit 3
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 57 participants 60 participants 117 participants
43.6  (11.6) 40.5  (11.9) 42.0  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 60 participants 117 participants
Female
45
  78.9%
38
  63.3%
83
  70.9%
Male
12
  21.1%
22
  36.7%
34
  29.1%
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 57 participants 60 participants 117 participants
82.0  (10.6) 84.9  (12.9) 83.5  (11.9)
1.Primary Outcome
Title Change in Body Weight at End of Study Compared to Baseline
Hide Description Change in body weight at the end of study compared to baseline
Time Frame 12 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title IQP-VV-102 Placebo
Hide Arm/Group Description:

2 tablets twice a day

IQP-VV-102

2 tablets twice a day

Placebo

Overall Number of Participants Analyzed 57 60
Mean (Standard Deviation)
Unit of Measure: kg
3.29  (2.30) 0.83  (2.00)
2.Secondary Outcome
Title Change in Waist Circumference (in cm) at End of Study From Baseline
Hide Description Difference in waist circumference (in cm) at end of study from baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IQP-VV-102 Placebo
Hide Arm/Group Description:

2 tablets twice a day

IQP-VV-102

2 tablets twice a day

Placebo

Overall Number of Participants Analyzed 57 60
Mean (Standard Deviation)
Unit of Measure: cm
2.11  (2.09) 0.81  (2.02)
3.Secondary Outcome
Title Change in Mean Body Fat at End of Study From Baseline
Hide Description Measured in kg using calibrated weighing scales
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IQP-VV-102 Placebo
Hide Arm/Group Description:

2 tablets twice a day

IQP-VV-102

2 tablets twice a day

Placebo

Overall Number of Participants Analyzed 57 60
Mean (Standard Deviation)
Unit of Measure: kg
2.14  (3.42) 0.56  (2.43)
Time Frame 12 weeks
Adverse Event Reporting Description All adverse effect reported were not deemed associated with the investigational product
 
Arm/Group Title IQP-VV-102 Placebo
Hide Arm/Group Description

2 tablets twice a day

IQP-VV-102

2 tablets twice a day

Placebo

All-Cause Mortality
IQP-VV-102 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
IQP-VV-102 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/57 (0.00%)      0/60 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IQP-VV-102 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/57 (8.77%)      8/60 (13.33%)    
Endocrine disorders     
Hypothyrodism *  1/57 (1.75%)  0/60 (0.00%) 
Gastrointestinal disorders     
Vomitting and diarhoea *  1/57 (1.75%)  1 1/60 (1.67%)  1
General disorders     
Headache *  0/57 (0.00%)  3/60 (5.00%) 
Bruised left thigh *  0/57 (0.00%)  1/60 (1.67%) 
Renal and urinary disorders     
Urinary Tract Infection *  2/57 (3.51%)  2 0/60 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory infections *  1/57 (1.75%)  1 3/60 (5.00%)  3
*
Indicates events were collected by non-systematic assessment
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Christof Jänicke
Organization: Analyze & Realize GmBH
Phone: +49 30 40 00 83 23
EMail: cj@a-r.com
Layout table for additonal information
Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01681069    
Other Study ID Numbers: INQ/009712
First Submitted: September 4, 2012
First Posted: September 7, 2012
Results First Submitted: September 1, 2015
Results First Posted: November 6, 2015
Last Update Posted: November 6, 2015