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Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Type II Diabetes

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ClinicalTrials.gov Identifier: NCT02481141
Recruitment Status : Completed
First Posted : June 25, 2015
Results First Posted : December 11, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
SBI Pharmaceuticals Co, Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: 5-ALA-SFC
Drug: Placebo
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5-ALA-SFC Placebo
Hide Arm/Group Description

Study product administration will be as follows:

Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks

5-ALA-SFC: Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA – SFC

Study matching placebo administration will be as follows:

Beginning Week 0: 1 capsule twice per day for 2 weeks Beginning Week 2: 1 capsule twice per day for 2 weeks Beginning Week 4: 1 capsule twice per day for 8 weeks

Placebo

Period Title: Overall Study
Started 35 18
Completed 26 13
Not Completed 9 5
Arm/Group Title 5-ALA-SFC Placebo Total
Hide Arm/Group Description

Study product administration will be as follows:

Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks

5-ALA-SFC: Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA – SFC

Study matching placebo administration will be as follows:

Beginning Week 0: 1 capsule twice per day for 2 weeks Beginning Week 2: 1 capsule twice per day for 2 weeks Beginning Week 4: 1 capsule twice per day for 8 weeks

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 35 15 50
Hide Baseline Analysis Population Description
Intent-to-Treat Population (ITT) included all patients who took at least one dose of study product and had at least one post-baseline efficacy evaluation
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 15 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
  94.3%
15
 100.0%
48
  96.0%
>=65 years
2
   5.7%
0
   0.0%
2
   4.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 15 participants 50 participants
52.4  (6.51) 51.9  (5.07) 52.2  (6.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 15 participants 50 participants
Female
2
   5.7%
2
  13.3%
4
   8.0%
Male
33
  94.3%
13
  86.7%
46
  92.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Bahrain Number Analyzed 35 participants 15 participants 50 participants
35 15 50
1.Primary Outcome
Title Subjects With Adverse Events as a Measure of Safety and Tolerability
Hide Description The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA – SFC in a population of patients with type 2 diabetes mellitus living in Bahrain.
Time Frame Week 2, Week 4, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all subjects who took at least one dose of study product.
Arm/Group Title 5-ALA-SFC Through Week 2 (50 mg 2x/Day) 5-ALA-SFC Through Week 4 (75 mg 2x/Day) 5-ALA-SFC Through Week 12 (100 mg 2x/Day) Placebo Through Week 2 Placebo Through Week 4 Placebo Through Week 12
Hide Arm/Group Description:

Study product administration will be as follows:

Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks

Study product administration will be as follows:

Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks

Study product administration will be as follows:

Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks

Study matching placebo administration will be as follows:

Beginning Week 0: 1 capsule twice per day for 2 weeks

Study matching placebo administration will be as follows:

Beginning Week 2: 1 capsule twice per day for 2 weeks

Study matching placebo administration will be as follows:

Beginning Week 4: 1 capsule twice per day for 8 weeks

Overall Number of Participants Analyzed 35 35 35 18 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
6
  17.1%
8
  22.9%
2
   5.7%
3
  16.7%
1
   5.6%
1
   5.6%
2.Primary Outcome
Title Change From Baseline in Fasting Blood Glucose
Hide Description The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA – SFC in a population of patients with type 2 diabetes mellitus living in Bahrain.
Time Frame Baseline, Week 2, Week 4, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.
Arm/Group Title 5-ALA-SFC Through Week 2 (50 mg 2x/Day) Change From Baseline 5-ALA-SFC Through Week 4 (75 mg 2x/Day) Change From Baseline 5-ALA-SFC Through Wk 12 (100 mg 2x/Day) Change From Baseline Placebo Through Week 2 Change From Baseline Placebo Through Week 4 Change From Baseline Placebo Through Week 12 Change From Baseline
Hide Arm/Group Description:

Study product administration will be as follows:

Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks

Study product administration will be as follows:

Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks

Study product administration will be as follows:

Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks

Study matching placebo administration will be as follows:

Beginning Week 0: 1 capsule twice per day for 2 weeks

Study matching placebo administration will be as follows:

Beginning Week 2: 1 capsule twice per day for 2 weeks

Study matching placebo administration will be as follows:

Beginning Week 4: 1 capsule twice per day for 8 weeks

Overall Number of Participants Analyzed 33 30 22 14 14 12
Mean (Standard Error)
Unit of Measure: mg/dL
2.3  (3.4) -0.2  (4.9) -3.0  (4.4) -7.3  (5.2) -0.8  (7.2) -4.2  (5.9)
3.Secondary Outcome
Title Change From Baseline in 2 Hour Post Meal Glucose Level
Hide Description Change from baseline in blood glucose levels 2 hours after breakfast
Time Frame Baseline, Week 2, Week 4, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.
Arm/Group Title 5-ALA-SFC Through Week 2 (50 mg 2x/Day) Change From Baseline 5-ALA-SFC Through Week 4 (75 mg 2x/Day) Change From Baseline 5-ALA-SFC Through Week 12 (100 mg 2x/Day) Change From Baseline Placebo Through Week 2 Change From Baseline Placebo Through Week 4 Change From Baseline Placebo Through Week 12 Change From Baseline
Hide Arm/Group Description:

Study product administration will be as follows:

Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks

Study product administration will be as follows:

Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks

Study product administration will be as follows:

Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks

Study matching placebo administration will be as follows:

Beginning Week 0: 1 capsule twice per day for 2 weeks

Study matching placebo administration will be as follows:

Beginning Week 2: 1 capsule twice per day for 2 weeks

Study matching placebo administration will be as follows:

Beginning Week 4: 1 capsule twice per day for 8 weeks

Overall Number of Participants Analyzed 33 30 21 14 12 10
Mean (Standard Error)
Unit of Measure: mg/dL
-0.2  (5.1) -12.9  (6.1) -8.5  (9.8) -26.5  (7.8) -18.8  (9.9) -33.0  (14.2)
4.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Change from baseline measured at week 6 and week 12 only
Time Frame Baseline, Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.
Arm/Group Title 5-ALA-SFC Through Week 6 Change From Baseline 5-ALA-SFC Through Week 12 Change From Baseline Placebo Through Week 6 Change From Baseline Placebo Through Week 12 Change From Baseline
Hide Arm/Group Description:
Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
Week 6: 1 placebo capsule twice per day
Week 12: 1 placebo capsule twice per day
Overall Number of Participants Analyzed 30 26 13 13
Mean (Standard Error)
Unit of Measure: kg
-0.1  (0.5) -0.2  (0.3) -0.3  (0.7) -0.8  (0.4)
5.Secondary Outcome
Title Change From Baseline in HbA1c
Hide Description Change from baseline in HbA1c %
Time Frame Baseline, Week 2, Week 4, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.
Arm/Group Title 5-ALA-SFC Through Week 2 (50 mg 2x/Day) Change From Baseline 5-ALA-SFC Through 4 (75 mg 2x/Day) Change From Baseline 5-ALA-SFC Through 12 (100 mg 2x/Day) Change From Baseline Placebo Through Week 2 Change From Baseline Placebo Through Week 4 Change From Baseline Placebo Through Week 12 Change From Baseline
Hide Arm/Group Description:

Study product administration will be as follows:

Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks

Study product administration will be as follows:

Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks

Study product administration will be as follows:

Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks

Study matching placebo administration will be as follows:

Beginning Week 0: 1 capsule twice per day for 2 weeks

Study matching placebo administration will be as follows:

Beginning Week 2: 1 capsule twice per day for 2 weeks

Study matching placebo administration will be as follows:

Beginning Week 4: 1 capsule twice per day for 8 weeks

Overall Number of Participants Analyzed 32 30 25 13 13 13
Mean (Standard Error)
Unit of Measure: percentage of HbA1c
-0.2  (0.1) -0.3  (0.1) -0.7  (0.2) -0.5  (0.2) -0.5  (0.2) -0.5  (0.2)
6.Secondary Outcome
Title Change From Baseline in Total Cholesterol (Component of Lipid Profile)
Hide Description Change from baseline measured at week 6 and week 12 only
Time Frame Baseline, Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.
Arm/Group Title 5-ALA-SFC Through Week 6 Change From Baseline 5-ALA-SFC Through Week 12 Change From Baseline Placebo Through Week 6 Change From Baseline Placebo Through Week 12 Change From Baseline
Hide Arm/Group Description:
Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
Week 6: 1 placebo capsule twice per day
Week 12: 1 placebo capsule twice per day
Overall Number of Participants Analyzed 27 25 13 13
Mean (Standard Error)
Unit of Measure: mg/dL
-5.2  (3.7) 6.8  (3.5) -7.6  (5.5) -0.1  (5.0)
7.Secondary Outcome
Title Change From Baseline LDL (Component of Lipid Profile)
Hide Description Change from baseline measured at week 6 and week 12 only
Time Frame Baseline, Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.
Arm/Group Title 5-ALA-SFC Through Week 6 Change From Baseline 5-ALA-SFC Through Week 12 Change From Baseline Placebo Through Week 6 Change From Baseline Placebo Through Week 12 Change From Baseline
Hide Arm/Group Description:
Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
Week 6: 1 placebo capsule twice per day
Week 12: 1 placebo capsule twice per day
Overall Number of Participants Analyzed 27 25 13 13
Mean (Standard Error)
Unit of Measure: mg/dL
-2.9  (3.2) 7.6  (3.3) -11.8  (4.7) -4.0  (4.6)
8.Secondary Outcome
Title Change From Baseline in HDL (Component of Lipid Profile)
Hide Description Change from baseline measured at week 6 and week 12 only
Time Frame Baseline, Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.
Arm/Group Title 5-ALA-SFC Through Week 6 Change From Baseline 5-ALA-SFC Through Week 12 Change From Baseline Placebo Through Week 6 Change From Baseline Placebo Through Week 12 Change From Baseline
Hide Arm/Group Description:
Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
Week 6: 1 placebo capsule twice per day
Week 12: 1 placebo capsule twice per day
Overall Number of Participants Analyzed 27 25 13 13
Mean (Standard Error)
Unit of Measure: mg/dL
-0.8  (1.0) 0.5  (1.0) -1.6  (1.4) -1.1  (1.4)
9.Secondary Outcome
Title Change From Baseline in Triglycerides (Component of Lipid Profile)
Hide Description Change from baseline measured at week 6 and week 12 only
Time Frame Baseline, Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.
Arm/Group Title 5-ALA-SFC Through Week 6 Change From Baseline 5-ALA-SFC Through Week 12 Change From Baseline Placebo Through Week 6 Change From Baseline Placebo Through Week 12 Change From Baseline
Hide Arm/Group Description:
Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
Week 6: 1 placebo capsule twice per day
Week 12: 1 placebo capsule twice per day
Overall Number of Participants Analyzed 27 25 13 13
Mean (Standard Error)
Unit of Measure: mg/dL
-1.3  (14.6) 3.2  (11.1) 4.5  (21.1) 11.9  (15.4)
Time Frame All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5-ALA-SFC Through Week 2 5-ALA-SFC Through Week 4 5-ALA-SFC Through Week 12 Placebo Through Week 2 Placebo Through Week 4 Placebo Through Week 12
Hide Arm/Group Description Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks Beginning Week 0: 1 placebo capsule twice per day for 2 weeks Beginning Week 2: 1 placebo capsule twice per day for 2 weeks Beginning Week 4: 1 placebo capsule twice per day for 8 weeks
All-Cause Mortality
5-ALA-SFC Through Week 2 5-ALA-SFC Through Week 4 5-ALA-SFC Through Week 12 Placebo Through Week 2 Placebo Through Week 4 Placebo Through Week 12
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)      0/35 (0.00%)      0/35 (0.00%)      0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
5-ALA-SFC Through Week 2 5-ALA-SFC Through Week 4 5-ALA-SFC Through Week 12 Placebo Through Week 2 Placebo Through Week 4 Placebo Through Week 12
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/35 (2.86%)      0/35 (0.00%)      0/35 (0.00%)      0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Infections and infestations             
Abscess in the nose 1 [1]  1/35 (2.86%)  1 0/35 (0.00%)  0 0/35 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
[1]
One serious adverse event of a nasal abscess requiring hospitalization was reported by a subject receiving 5-ALA-SFC, which was not related to study product.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
5-ALA-SFC Through Week 2 5-ALA-SFC Through Week 4 5-ALA-SFC Through Week 12 Placebo Through Week 2 Placebo Through Week 4 Placebo Through Week 12
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/35 (17.14%)      14/35 (40.00%)      16/35 (45.71%)      3/18 (16.67%)      4/18 (22.22%)      5/18 (27.78%)    
Cardiac disorders             
Palpitations  0/35 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders             
Abdominal Distension  0/35 (0.00%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Abdominal pain upper  1/35 (2.86%)  2/35 (5.71%)  2/35 (5.71%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Constipation  0/35 (0.00%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Diarrhoea  2/35 (5.71%)  2/35 (5.71%)  2/35 (5.71%)  0/18 (0.00%)  1/18 (5.56%)  2/18 (11.11%) 
Dyspepsia  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Faeces discoloured  0/35 (0.00%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Faeces hard  0/35 (0.00%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorder  0/35 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Nausea  0/35 (0.00%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
General disorders             
Fatigue  0/35 (0.00%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Pyrexia  0/35 (0.00%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Investigations             
Blood Glucose Increased  0/35 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite  0/35 (0.00%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Hypoglycaemia  0/35 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  1/18 (5.56%)  1/18 (5.56%)  1/18 (5.56%) 
Hypokalemia  0/35 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders             
Groin pain  0/35 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  1/18 (5.56%)  1/18 (5.56%)  1/18 (5.56%) 
Nervous system disorders             
Headache  0/35 (0.00%)  1/35 (2.86%)  2/35 (5.71%)  1/18 (5.56%)  1/18 (5.56%)  1/18 (5.56%) 
Reproductive system and breast disorders             
Erectile dysfunction  0/35 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1/35 (2.86%)  2/35 (5.71%)  2/35 (5.71%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Nasal congestion  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders             
Alopecia  0/35 (0.00%)  1/35 (2.86%)  1/35 (2.86%)  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Dr. Riyadh Rehani, President of MENA Region
Organization: SBI Pharmaceuticals Co, Ltd.
Phone: +973 66394100
Responsible Party: SBI Pharmaceuticals Co, Ltd.
ClinicalTrials.gov Identifier: NCT02481141     History of Changes
Other Study ID Numbers: SBIP12-002F
First Submitted: June 17, 2015
First Posted: June 25, 2015
Results First Submitted: November 3, 2016
Results First Posted: December 11, 2017
Last Update Posted: May 22, 2018