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Efficacy of Alitretinoin Treatment in Patients With Pustular Form of Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01245140
Recruitment Status : Completed
First Posted : November 22, 2010
Results First Posted : April 4, 2017
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
Basilea Pharmaceutica
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: alitretinoin
Drug: Placebo
Enrollment 33
Recruitment Details The study was conducted at 7 centers from 26 April 2011 to 16 April 2014, in male and female participants of Palmo-plantar pustulosis (PPP), aged >= 18 years.
Pre-assignment Details The total study duration was 33 weeks, with a Screening Period of up to 4 weeks, followed by 24 weeks of treatment and a 5-week safety Follow-up Period. Participants who met eligibility criteria were randomized (2:1) to receive 30 milligrams (mg) alitretinoin or matching placebo, given orally as gelatin capsules, once daily (QD) for up to 24 weeks.
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description Participants received matching placebo orally once daily (QD) for up to 24 weeks. Participants received an alitretinoin 30 milligram (mg) capsule orally QD for up to 24 weeks.
Period Title: Overall Study
Started 9 24
Completed 6 14
Not Completed 3 10
Reason Not Completed
Adverse Event             1             3
Lack of Efficacy             2             4
Protocol Violation             0             1
Withdrawal by Subject             0             1
Refused Treatment/Did Not Coopera             0             1
Arm/Group Title Matching Placebo Alitretinoin 30 mg Total
Hide Arm/Group Description Participants received matching placebo orally QD for up to 24 weeks. Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 9 24 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 24 participants 33 participants
49.00  (16.32) 48.83  (14.94) 48.88  (15.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 24 participants 33 participants
Female
5
  55.6%
14
  58.3%
19
  57.6%
Male
4
  44.4%
10
  41.7%
14
  42.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 24 participants 33 participants
Caucasian/White 8 22 30
Oriental 1 0 1
Black 0 1 1
North African 0 1 1
1.Primary Outcome
Title Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment
Hide Description The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis [PPP]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value.
Time Frame Baseline and EOT (Week 24) or the last assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set : treated participants with >=1 efficacy result after receiving study medication.
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-44.6  (45.9) -45.2  (32.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo, Alitretinoin 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9705
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.5731
Confidence Interval (2-Sided) 95%
-30.9738 to 32.1200
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With PPPASI 50 Response and PPPASI 75 Response
Hide Description The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis [PPP]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. PPPASI 50 response and PPPASI 75 response are defined as a 50% and 75% decrease, respectively, in the PPPASI score from Baseline.
Time Frame From Baseline until EOT (Week 24) or the last assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 22
Measure Type: Number
Unit of Measure: Participants
PPPASI 50 response 6 11
PPPASI 75 response 3 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo, Alitretinoin 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4564
Comments PPPASI 50 response
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Matching Placebo, Alitretinoin 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6595
Comments PPPASI 75 response
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24)
Hide Description The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the EOT visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole.
Time Frame Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 22
Mean (Standard Deviation)
Unit of Measure: Pustule count
Baseline, n=9, 22 82.7  (59.1) 106.0  (128.2)
Week 4, n=9, 20 71.6  (66.5) 31.0  (43.5)
Week 8, n=7, 20 69.7  (30.8) 30.4  (38.6)
Week 12, n=7, 17 70.4  (63.2) 21.5  (37.8)
Week 16, n=6, 16 26.8  (25.5) 26.0  (42.0)
Week 20, n=6, 14 35.8  (37.7) 30.5  (51.2)
End of Treatment, n=8, 20 55.4  (104.5) 33.6  (49.6)
4.Secondary Outcome
Title Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24)
Hide Description The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the End of Treatment visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.
Time Frame Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 22
Mean (Standard Deviation)
Unit of Measure: Pustule count
Week 4, n=9, 20 -11.1  (58.4) -75.3  (113.2)
Week 8, n=7, 20 -7.9  (51.5) -75.9  (124.4)
Week 12, n=7, 17 -7.1  (75.5) -74.2  (111.7)
Week 16, n=6, 16 -55.2  (56.5) -75.6  (113.0)
Week 20, n=6, 14 -46.2  (37.8) -65.1  (106.4)
End of Treatment, n=8, 20 -31.3  (79.4) -82.1  (121.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo, Alitretinoin 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments Change in Total Pustule Count: BL to Last Visit
Method Wilcoxon test: Exact Test
Comments [Not Specified]
5.Secondary Outcome
Title Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)
Hide Description Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on the redness, thickness, and scaliness scores of plaques (0-4 each) for the head, upper extremities, trunk, and lower extremities and the area of psoriatic involvement score (0-6). The lowest possible mPASI score was zero and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values.
Time Frame Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline, n=9, 21 0.2  (0.4) 0.5  (0.9)
Week 4, n=9, 20 0.3  (0.6) 0.4  (0.9)
Week 8, n=7, 20 0.0  (0.1) 0.4  (0.9)
Week 12, n=7, 17 0.0  (0.1) 0.4  (0.9)
Week 16, n=6, 16 0.0  (0.0) 0.2  (0.5)
Week 20, n=6, 14 0.0  (0.1) 0.1  (0.3)
End of Treatment, n=8, 20 0.7  (1.9) 0.3  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo, Alitretinoin 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments Relative change in mPASI score: BL to Last Visit
Method Wilcoxon test: Exact Test
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment
Hide Description Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on redness, thickness, and scaliness scores of plaques (0-4 each) for head, upper extremities, trunk, lower extremities and area of psoriatic involvement score (0-6). Lowest possible mPASI score was 0 and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values. Change from Baseline is defined as the value at EOT minus baseline value.
Time Frame Baseline and EOT (Week 24) or the last assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-95.8  (7.2) -51.0  (38.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo, Alitretinoin 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2358
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squared estimation
Estimated Value 49.4927
Confidence Interval (2-Sided) 95%
-49.0830 to 148.07
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With mPASI 50 Response and mPASI 75 Response
Hide Description Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). The fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated. mPASI 50 response and mPASI 75 response is defined as a 50% and 75% decrease, respectively, in the mPASI score from Baseline.
Time Frame From Baseline until EOT (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Participants with lesions in areas of the body other than the hands and feet were assessed.
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 3 6
Measure Type: Number
Unit of Measure: Participants
mPASI 50 response 3 2
mPASI 75 response 3 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo, Alitretinoin 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1667
Comments mPASI 50 response
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Matching Placebo, Alitretinoin 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1667
Comments mPASI 75 response
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24)
Hide Description The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24).
Time Frame Baseline, Week 12, and EOT (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
NAPSI-bed, Baseline, n=9, 20 1.1  (2.3) 1.2  (1.9)
NAPSI-bed, Week 12, n=7, 17 0.4  (1.1) 1.3  (3.3)
NAPSI-bed, End of Treatment, n=8, 19 1.6  (2.8) 0.9  (2.0)
NAPSI-matrix, Baseline, n=9, 20 3.9  (6.2) 3.6  (6.2)
NAPSI-matrix, Week 12, n=7, 17 2.1  (3.7) 2.6  (6.0)
NAPSI-matrix, End of Treatment, n=8, 19 4.3  (6.0) 2.6  (6.0)
9.Secondary Outcome
Title Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24)
Hide Description The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.
Time Frame Baseline, Week 12, and EOT (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
NAPSI-bed, Week 12, n=7, 17 -0.4  (1.1) 0.3  (2.4)
NAPSI-bed, End of Treatment, n=8, 18 0.4  (2.2) -0.3  (1.6)
NAPSI-matrix, Week 12, n=7, 17 -1.4  (3.8) -0.5  (2.0)
NAPSI-matrix, End of Treatment, n=8, 18 0.8  (5.5) -0.1  (5.0)
10.Secondary Outcome
Title Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment
Hide Description An AE was any adverse change from the participant’s Baseline (pre-treatment) clinical condition, including intercurrent illness, which occurred during the course of a clinical study after written informed consent had been given, whether considered related to treatment or not. The relationship of AEs to the study treatment was assessed as unrelated, remotely related, possibly related, and probably related. For an AE to be considered serious, it fell into one or more of the following categories: results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, and is a congenital abnormality or birth defect.
Time Frame From Baseline until safety follow up (Week 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants who received at least one dose of study medication
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Measure Type: Number
Unit of Measure: Participants
Any AE 8 18
Any AE remotely related to study medication 6 15
Any SAE 0 1
Any SAE remotely related to study medication 0 1
11.Secondary Outcome
Title Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29)
Hide Description Fasted lipid laboratory parameters included triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.
Time Frame Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
Triglycerides, Week 4, n=9, 19 0.6  (2.3) 2.4  (3.7)
Triglycerides, Week 8, n=7, 20 1.0  (1.9) 3.8  (5.7)
Triglycerides, Week 12, n=6, 17 2.5  (3.6) 5.8  (8.7)
Triglycerides, Week 16, n=5, 16 2.6  (1.7) 4.2  (5.2)
Triglycerides, Week 20, n=6, 14 2.6  (4.1) 5.6  (6.2)
Triglycerides, End of Treatment, n=7, 20 -0.7  (2.5) 3.3  (5.6)
Triglycerides, safety follow-up, n=9, 21 1.2  (3.4) 2.8  (5.8)
Total cholesterol, Week 4, n=9, 19 0.0  (0.5) 0.6  (0.6)
Total cholesterol, Week 8, n=7, 20 -0.2  (0.5) 0.7  (0.8)
Total cholesterol, Week 12, n=6, 17 0.1  (0.3) 0.7  (0.9)
Total cholesterol, Week 16, n=5, 16 0.1  (0.5) 0.6  (0.8)
Total cholesterol, Week 20, n=6, 14 0.1  (0.8) 0.7  (1.1)
Total cholesterol, End of Treatment, n=8, 20 -0.1  (0.5) 0.7  (0.7)
Total cholesterol, safety follow-up, n=9, 22 -0.0  (0.5) 0.3  (0.8)
HDL cholesterol, Week 4, n=8, 19 -0.1  (0.2) -0.1  (0.1)
HDL cholesterol, Week 8, n=7, 20 -0.1  (0.2) -0.2  (0.2)
HDL cholesterol, Week 12, n=6, 17 -0.0  (0.2) -0.2  (0.2)
HDL cholesterol, Week 16, n=5, 16 -0.1  (0.1) -0.2  (0.2)
HDL cholesterol, Week 20, n=6, 14 -0.0  (0.2) -0.2  (0.2)
HDL cholesterol, End of Treatment, n=7, 20 -0.1  (0.2) -0.1  (0.2)
HDL cholesterol, safety follow-up, n=9, 22 -0.1  (0.2) -0.0  (0.2)
LDL cholesterol, Week 4, n=8, 19 0.2  (0.3) 0.6  (0.5)
LDL cholesterol, Week 8, n=7, 20 0.0  (0.5) 0.5  (0.6)
LDL cholesterol, Week 12, n=6, 17 -0.1  (0.4) 0.6  (0.6)
LDL cholesterol, Week 16, n=5, 16 0.0  (0.5) 0.4  (0.5)
LDL cholesterol, Week 20, n=6, 14 -0.0  (0.6) 0.6  (0.9)
LDL cholesterol, End of Treatment, n=7, 20 0.0  (0.4) 0.4  (0.6)
LDL cholesterol, safety follow-up, n=9, 22 0.0  (0.3) 0.3  (0.5)
12.Secondary Outcome
Title Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29)
Hide Description Change from Baseline is defined as the value at the safety follow up visit minus baseline value.
Time Frame Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24) and safety follow-up (Week 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
Arm/Group Title Matching Placebo Alitretinoin 30 mg
Hide Arm/Group Description:
Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline, n=7, 22 0.0  (0.0) 0.0  (0.0)
Week 4, n=6, 17 0.3  (0.2) 0.7  (0.4)
Week 8, n=6, 18 0.2  (0.6) 0.9  (0.6)
Week 12, n=5, 16 0.2  (0.4) 0.9  (0.9)
Week 16, n=5, 15 0.1  (0.5) 0.9  (0.7)
Week 20, n=6, 13 0.0  (0.5) 0.7  (1.1)
End of Treatment, n=7, 19 0.1  (0.4) 0.5  (0.8)
Safety follow-up, n=7, 20 0.1  (0.4) 0.1  (0.6)
13.Secondary Outcome
Title Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24)
Hide Description Laboratory parameters included triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, LDL/HDL ratio, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and amylase and lipase. The central laboratory classified a finding as either abnormal or normal.
Time Frame From Baseline until EOT (Week 24)
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Safety Population
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Measure Type: Number
Unit of Measure: Participants
Triglycerides, BL normal, shift to abnormal 0 2
Triglycerides, BL abnormal, shift to abnormal 0 0
Total cholesterol BL normal, shift to abnormal 1 1
Total cholesterol BL abnormal, shift to abnormal 0 1
HDL cholesterol BL normal, shift to abnormal 0 1
HDL cholesterol BL abnormal, shift to abnormal 0 0
LDL cholesterol BL normal, shift to abnormal 0 0
LDL cholesterol BL abnormal, shift to abnormal 0 1
LDL/HDL ratio BL normal, shift to abnormal 0 0
LDL/HDL ratio BL abnormal, shift to abnormal 0 0
ALT BL normal, shift to abnormal 0 0
ALT BL abnormal, shift to abnormal 0 0
AST BL normal, shift to abnormal 0 0
AST BL abnormal, shift to abnormal 0 0
Bilirubin BL normal, shift to abnormal 0 0
Bilirubin BL abnormal, shift to abnormal 0 0
Amylase BL normal, shift to abnormal 0 0
Amylase BL abnormal, shift to abnormal 0 0
Lipase BL normal, shift to abnormal 0 0
Lipase BL abnormal, shift to abnormal 0 0
14.Secondary Outcome
Title Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)
Hide Description The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of 20 or higher were re-evaluated within 2 weeks. If a CES-D score of 20 or higher was confirmed on the second occasion, and if the score represents an increase over Baseline of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation.
Time Frame Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)
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Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Screening, n=9, 23 7.2  (6.6) 5.7  (4.7)
Baseline, n=9, 24 7.0  (5.9) 4.5  (5.9)
Week 4, n=9, 20 5.0  (4.7) 2.9  (3.5)
Week 8, n=7, 20 2.7  (2.8) 3.8  (6.7)
Week 12, n=7, 17 4.0  (5.7) 4.2  (6.6)
Week 16, n=6, 16 3.8  (4.8) 2.9  (5.5)
Week 20, n=6, 14 4.0  (3.6) 3.6  (5.2)
End of Treatment, n=8, 20 7.4  (9.0) 3.0  (5.4)
Safety follow up, n=9, 22 4.4  (3.9) 4.6  (6.7)
15.Secondary Outcome
Title Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)
Hide Description The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of >=20 were re-evaluated within 2 weeks. If a CES-D score of >=20 was confirmed on the second occasion, and if the score represents an increase over BL of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation. Change from BL is defined as the post-BL value minus the BL value.
Time Frame Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)
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Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 4, n=9, 20 -2.0  (2.5) -0.3  (2.4)
Week 8, n=7, 20 -2.3  (2.4) 0.7  (7.5)
Week 12, n=7, 17 -1.0  (2.3) 0.6  (5.4)
Week 16, n=6, 16 -2.0  (2.1) -0.8  (4.7)
Week 20, n=6, 14 -1.8  (3.6) 0.3  (4.7)
End of Treatment, n=8, 20 -0.5  (6.6) -0.6  (4.7)
Safety follow-up, n=9, 22 -2.6  (3.9) 0.1  (3.4)
16.Secondary Outcome
Title Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)
Hide Description The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Screening; Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24);and safety follow-up (Week 29).
Time Frame Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24), and safety follow-up (Week 29)
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Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Screening, n=3, 10 0.0  (0.0) 0.0  (0.0)
Baseline, n=3, 10 0.0  (0.0) 0.0  (0.0)
Week 4, n=3, 09 0.0  (0.0) 0.0  (0.0)
Week 8, n=3, 09 0.0  (0.0) 0.0  (0.0)
Week 12, n=3, 07 0.0  (0.0) 0.0  (0.0)
Week 16, n=2, 07 0.0  (0.0) 0.0  (0.0)
Week 20, n=2, 6 0.0  (0.0) 0.0  (0.0)
End of Treatment, n=2, 7 0.0  (0.0) 0.0  (0.0)
Safety follow up, n=3, 9 0.0  (0.0) 0.0  (0.0)
17.Secondary Outcome
Title Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)
Hide Description The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24); and safety follow-up (Week 29). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.
Time Frame Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)
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Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 4, n=3, 9 0.0  (0.0) 0.0  (0.0)
Week 8, n=3, 9 0.0  (0.0) 0.0  (0.0)
Week 12, n=3, 7 0.0  (0.0) 0.0  (0.0)
Week 16, n=2, 7 0.0  (0.0) 0.0  (0.0)
Week 20, n=2, 6 0.0  (0.0) 0.0  (0.0)
End of Treatment, n=2, 7 0.0  (0.0) 0.0  (0.0)
Safety follow-up, n=3, 9 0.0  (0.0) 0.0  (0.0)
18.Secondary Outcome
Title Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24)
Hide Description SBP and DBP were assessed at Screening, Baseline, and EOT.
Time Frame Screening, Baseline, and EOT (Week 24)
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Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
SBP, Screening, n=9, 23 130.8  (13.7) 131.3  (16.3)
SBP, Baseline, n=9, 24 122.8  (14.0) 126.3  (16.1)
SBP, EOT, n=8, 20 122.4  (13.7) 128.7  (21.4)
DBP, Screening, n=9, 23 78.0  (10.7) 79.7  (9.6)
DBP, Baseline, n=9, 24 77.4  (12.2) 79.1  (7.5)
DBP, EOT, n=8, 20 76.0  (12.2) 75.4  (10.5)
19.Secondary Outcome
Title Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24)
Hide Description HR is defined as the rate at which the heart beats.
Time Frame Screening, Baseline, and EOT (Week 24)
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Hide Analysis Population Description
Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Mean (Standard Deviation)
Unit of Measure: Beats per minute (bpm)
Screening, n=9, 23 68.3  (6.0) 74.0  (7.3)
Baseline, n=9, 24 72.3  (6.2) 75.2  (8.8)
EOT, n=8, 20 70.1  (6.6) 74.7  (7.8)
20.Secondary Outcome
Title Mean Body Weight at Screening, Baseline ,and EOT (Week 24)
Hide Description Body weight was measured at Screening, Baseline, and EOT.
Time Frame Screening, Baseline, and EOT (Week 24)
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Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Mean (Standard Deviation)
Unit of Measure: Kilograms (kg)
Screening, n=9, 24 89.3  (15.5) 72.8  (12.6)
Baseline, n=8, 24 89.6  (16.6) 72.9  (12.9)
EOT, n=8, 19 88.9  (16.5) 73.8  (13.4)
21.Secondary Outcome
Title Change From Baseline in SBP and DBP at EOT (Week 24)
Hide Description Change from Baseline is defined as the value at EOT minus the Baseline value.
Time Frame Baseline and EOT (Week 24)
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Safety Population. Only those participants available at the specified time points were analyzed.
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 8 20
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP 0.5  (12.5) 0.7  (19.1)
DBP -0.5  (9.8) -4.2  (9.8)
22.Secondary Outcome
Title Change From Baseline in Heart Rate at EOT (Week 24)
Hide Description HR is defined as the rate at which the heart beats. Change from Baseline is defined as the value at EOT minus the Baseline value.
Time Frame Baseline and EOT (Week 24)
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Safety Population. Only those participants available at the specified time points were analyzed.
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 8 20
Mean (Standard Deviation)
Unit of Measure: bpm
-3.1  (10.4) -0.2  (10.2)
23.Secondary Outcome
Title Change From Baseline in Weight at EOT (Week 24)
Hide Description Change from Baseline is defined as the value at EOT minus the value at Baseline.
Time Frame Baseline and EOT (Week 24)
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Safety Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Matching Placebo Alitretinoin 30 mg
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 7 19
Mean (Standard Deviation)
Unit of Measure: kg
-0.8  (3.2) -0.5  (1.4)
24.Secondary Outcome
Title Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal
Hide Description A physical examination for each participant was performed at Baseline and at EOT (Week 24). The primary investigator classified physical status as either normal or abnormal.
Time Frame Baseline and EOT (Week 24)
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Safety Population
Arm/Group Title Matching Placebo Alitretinoin 30 mg
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 9 24
Measure Type: Number
Unit of Measure: Participants
Baseline normal, worst post-Baseline normal 6 18
Baseline normal, worst post-Baseline abnormal 1 0
Baseline abnormal, worst post-Baseline normal 1 1
Baseline abnormal, worst post-Baseline abnormal 0 0
25.Secondary Outcome
Title Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)
Hide Description Serum pregnancy tests were performed at each visit for females of childbearing potential.
Time Frame Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); safety follow-up (Week 29)
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Safety population. Only female participants were analysed for serum pregnancy test.
Arm/Group Title Matching Placebo Alitretinoin 30 mg
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Participants received matching placebo orally QD for up to 24 weeks.
Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
Overall Number of Participants Analyzed 5 14
Measure Type: Number
Unit of Measure: Participants
Screening 4 7
Baseline 4 7
Week 4 4 4
Week 8 3 4
Week 12 3 3
Week 16 3 2
Week 20 2 2
EOT 4 4
Safety follow-up 4 5
Time Frame AEs were recorded from date of randomization until the date of death from any cause, withdrawal from study or up to safety follow-up, whichever came first, assessed up to 29 weeks.
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
 
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Hide Arm/Group Description Participants received matching placebo orally QD for up to 24 weeks. Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
All-Cause Mortality
Matching Placebo Alitretinoin 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Matching Placebo Alitretinoin 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   1/24 (4.17%) 
Nervous system disorders     
Dizziness  1  0/9 (0.00%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Matching Placebo Alitretinoin 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   8/9 (88.89%)   16/24 (66.67%) 
Gastrointestinal disorders     
Cheilitis  1  1/9 (11.11%)  3/24 (12.50%) 
Nausea  1  1/9 (11.11%)  2/24 (8.33%) 
Diarrhoea  1  1/9 (11.11%)  0/24 (0.00%) 
General disorders     
Discomfort  1  1/9 (11.11%)  0/24 (0.00%) 
Hepatobiliary disorders     
Hepatic fibrosis  1  1/9 (11.11%)  0/24 (0.00%) 
Immune system disorders     
Allergy to arthropod bite  1  1/9 (11.11%)  0/24 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  1/9 (11.11%)  7/24 (29.17%) 
Bronchitis  1  1/9 (11.11%)  1/24 (4.17%) 
Investigations     
Blood triglycerides increased  1  0/9 (0.00%)  2/24 (8.33%) 
LDL/HDL ratio increased  1  0/9 (0.00%)  2/24 (8.33%) 
Low density lipoprotein increased  1  0/9 (0.00%)  2/24 (8.33%) 
Blood potassium increased  1  1/9 (11.11%)  0/24 (0.00%) 
Blood pressure increased  1  1/9 (11.11%)  0/24 (0.00%) 
Gamma-glutamyltransferase increased  1  1/9 (11.11%)  0/24 (0.00%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  0/9 (0.00%)  3/24 (12.50%) 
Gout  1  1/9 (11.11%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/9 (22.22%)  1/24 (4.17%) 
Pain in extremity  1  0/9 (0.00%)  2/24 (8.33%) 
Joint swelling  1  1/9 (11.11%)  0/24 (0.00%) 
Nervous system disorders     
Headache  1  2/9 (22.22%)  8/24 (33.33%) 
Psychiatric disorders     
Insomnia  1  0/9 (0.00%)  2/24 (8.33%) 
Suicidal ideation  1  1/9 (11.11%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  1/9 (11.11%)  0/24 (0.00%) 
Oropharyngeal pain  1  1/9 (11.11%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders     
Granuloma annulare  1  1/9 (11.11%)  0/24 (0.00%) 
Pigmentation disorder  1  1/9 (11.11%)  0/24 (0.00%) 
Pruritus  1  1/9 (11.11%)  0/24 (0.00%) 
Skin lesion  1  1/9 (11.11%)  0/24 (0.00%) 
Vascular disorders     
Haematoma  1  1/9 (11.11%)  0/24 (0.00%) 
Hot flush  1  1/9 (11.11%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT01245140     History of Changes
Other Study ID Numbers: 117221
2010-022843-39 ( EudraCT Number )
BAP02028 ( Other Identifier: Basilea Pharmecutica )
First Submitted: November 16, 2010
First Posted: November 22, 2010
Results First Submitted: December 7, 2016
Results First Posted: April 4, 2017
Last Update Posted: December 21, 2017