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Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS) (SDALS-001)

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ClinicalTrials.gov Identifier: NCT01257581
Recruitment Status : Completed
First Posted : December 9, 2010
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
Sponsor:
Collaborators:
ALS Therapy Alliance
State University of New York - Upstate Medical University
Information provided by (Responsible Party):
Nazem Atassi, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Amyotrophic Lateral Sclerosis
Interventions Drug: creatine
Drug: tamoxifen
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description

Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.

This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.

Creatine is a nutritional supplement and is not approved by the U.S. Food and Drug Administration (FDA) for treating ALS.

creatine: creatine monohydrate powder

Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.

This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.

Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.

tamoxifen: Tamoxifen citrate capsules

Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.

This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.

Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.

tamoxifen: Tamoxifen citrate capsules
Period Title: Overall Study
Started 22 21 17
Completed 17 18 11
Not Completed 5 3 6
Reason Not Completed
Early Termination             3             1             2
Death             2             2             4
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg Total
Hide Arm/Group Description Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks. Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks. Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks. Total of all reporting groups
Overall Number of Baseline Participants 22 21 17 60
Hide Baseline Analysis Population Description
Efficacy outcomes are adjusted for baseline differences in time from symptom onset to diagnosis, site of symptom onset, and VC.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 17 participants 60 participants
55.5  (11.4) 60.3  (10.6) 56.3  (11.3) 57.4  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 17 participants 60 participants
Female
6
  27.3%
4
  19.0%
9
  52.9%
19
  31.7%
Male
16
  72.7%
17
  81.0%
8
  47.1%
41
  68.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 17 participants 60 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
22
 100.0%
21
 100.0%
17
 100.0%
60
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 17 participants 60 participants
American Indian or Alaska Native
0
   0.0%
1
   4.8%
0
   0.0%
1
   1.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
22
 100.0%
20
  95.2%
17
 100.0%
59
  98.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 21 participants 17 participants 60 participants
22 21 17 60
Years from Symptom Onset to Screening  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 17 participants 60 participants
2.8  (1.7) 1.9  (1.4) 2.0  (1.0) 2.3  (1.5)
Years from Diagnosis to Screening  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 17 participants 60 participants
1.3  (0.8) 0.9  (0.8) 1.0  (0.8) 1.1  (0.8)
Years from Symptom Onset to Diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 17 participants 60 participants
1.6  (1.5) 0.9  (0.8) 1.0  (0.8) 1.2  (1.1)
Baseline ALS Functional Rating Scale - Revised (ALSFRS-R) Total   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 22 participants 21 participants 17 participants 60 participants
35.82  (7.20) 36.19  (6.04) 34.76  (6.56) 35.65  (6.54)
[1]
Measure Description: The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.
Baseline VC% Predicted Max   [1] 
Mean (Standard Deviation)
Unit of measure:  % of predicted max value
Number Analyzed 22 participants 21 participants 17 participants 60 participants
90.64  (20.29) 86.90  (13.92) 81.71  (19.93) 86.80  (18.31)
[1]
Measure Description: The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal.
1.Primary Outcome
Title Change in ALS Functional Rating Scale - Revised (ALSFRS-R)
Hide Description Primary efficacy will be assessed by analyzing the mean rate of decline in the ALS Functional Rating Scale-Revised (ALSFRS-R) score over nine months. The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
-0.905
(-1.292 to -0.518)
-0.983
(-1.336 to -0.630)
-0.743
(-1.259 to -0.227)
2.Secondary Outcome
Title Vital Capacity/Pulmonary Function Testing
Hide Description Secondary efficacy will be assessed by analyzing the change in the Slow Vital Capacity score over nine months. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percentage of predicted normal.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Mean (95% Confidence Interval)
Unit of Measure: Percentage of predicted max value
-3.386
(-4.794 to -1.977)
-2.915
(-4.216 to -1.615)
-3.377
(-5.203 to -1.552)
3.Secondary Outcome
Title Tracheostomy-free Survival
Hide Description Secondary efficacy will be assessed by analyzing rate of tracheostomy-free survival at nine months.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.455
(0.276 to 0.679)
0.286
(0.140 to 0.528)
0.412
(0.222 to 0.675)
4.Secondary Outcome
Title Dose Adjustments
Hide Description These events were due to a double-blinded study design.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Measure Type: Number
Unit of Measure: Number of Events due to Adverse Events
Number of Creatine Reductions due to AEs 6 3 0
Tamoxifen Redutions due to AEs 5 4 0
Suspensions due to AEs 9 1 2
Discontinuations due to AEs 10 5 4
5.Secondary Outcome
Title Lab Abnormal Reports by Treatment Assignment
Hide Description The safety data is summarized according to treatment arm. Total number of Adverse Events (AEs), AEs that cause study drug withdrawal and abnormal laboratory tests are compared among treatment arms. A lab abnormality was a result that was out of range and considered clinically significant by the site investigator.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Measure Type: Number
Unit of Measure: Events
ALT (SGOT) 0 1 0
Creatinine 4 0 0
Glucose 0 0 1
Hematocrit 1 0 0
Lymphocytes 1 0 0
MCH 1 0 0
Neutrophils 0 0 1
Absolute Neutrophils 0 0 1
GFR Non-African American 2 0 0
Potassium 0 0 1
Red Blood Count (RBC) 1 0 0
White Blood Count (WBC) 1 0 0
6.Secondary Outcome
Title Hand Held Dynamometry (HHD) Lower Z-score
Hide Description The HHD lower z-scores are means of z-scores for right and left knee extension, knee flexion, hip flexion, and ankle dorsiflexion with z-scores calculated relative to the baseline mean and standard deviation strength of each muscle group across all participants.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Mean (95% Confidence Interval)
Unit of Measure: Z-score
-0.094
(-0.127 to -0.061)
-0.067
(-0.096 to -0.039)
-0.016
(-0.052 to 0.020)
7.Secondary Outcome
Title HHD Lower % Baseline
Hide Description HHD % baseline measures are mean percent change for right and left knee extension, knee flexion, hip flexion, and ankle dorsiflexion from each participant's baseline.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Mean (95% Confidence Interval)
Unit of Measure: percent change
-9.258
(-13.118 to -5.399)
-6.711
(-10.302 to -3.121)
-2.897
(-7.440 to 1.646)
8.Secondary Outcome
Title HHD Upper Z-score
Hide Description The HHD upper z-scores are means of z-scores for right and left shoulder flexion, elbow extension, elbow flexion, write extension and first dorsal interosseous muscles with z-scores calculated relative to the baseline mean and standard deviation strength of each muscle group across all participants.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Mean (95% Confidence Interval)
Unit of Measure: Z-score
-0.103
(-0.159 to -0.048)
-0.089
(-0.142 to -0.037)
-0.039
(-0.105 to 0.027)
9.Secondary Outcome
Title HHD Upper % Baseline
Hide Description The HHD % baseline measures are mean percent change for shoulder flexion, elbow extension, elbow flexion, wrist extension, and first dorsal interosseous muscles from each participant's baseline.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Mean (95% Confidence Interval)
Unit of Measure: percent change
-8.451
(-11.726 to -5.175)
-7.720
(-10.697 to -4.743)
-4.515
(-8.063 to -0.968)
10.Secondary Outcome
Title Accurate Test of Limb Isometric Strength (ATLIS) Lower Percentage of Predicted Normal (PPN)
Hide Description The ATLIS PPN measures are percentages of predicted normal strength based on age, gender, height, and weight using normative data.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Mean (95% Confidence Interval)
Unit of Measure: percentages of predicted normal strength
-2.098
(-3.931 to -0.266)
-2.375
(-4.441 to -0.310)
-0.491
(-2.759 to 1.776)
11.Secondary Outcome
Title ATLIS Upper Percentage of Predicted Normal (PPN)
Hide Description The ATLIS PPN measures are percentages of predicted normal strength based on age, gender, height, and weight using normative data.
Time Frame 38 weeks of treatment followed by a telephone interview at 42 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description:
Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
Overall Number of Participants Analyzed 22 21 17
Mean (95% Confidence Interval)
Unit of Measure: percentages of predicted normal strength
-1.932
(-4.112 to 0.249)
-1.845
(-4.084 to 0.393)
0.436
(-2.143 to 3.016)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Hide Arm/Group Description Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks. Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks. Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
All-Cause Mortality
Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/22 (27.27%)      3/21 (14.29%)      5/17 (29.41%)    
Gastrointestinal disorders       
Abdominal Pain  1/22 (4.55%)  1 0/21 (0.00%)  0 0/17 (0.00%)  0
Abdominal Pain Upper  1/22 (4.55%)  1 0/21 (0.00%)  0 0/17 (0.00%)  0
Pneumoperitoneum  0/22 (0.00%)  0 1/21 (4.76%)  1 0/17 (0.00%)  0
General disorders       
Death  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Hepatobiliary disorders       
Cholecystitis Acute  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Infections and infestations       
Pneumonia  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Metabolism and nutrition disorders       
Malnutrition  1/22 (4.55%)  1 0/21 (0.00%)  0 0/17 (0.00%)  0
Nervous system disorders       
Subarachnoid Haemorrhage  1/22 (4.55%)  1 0/21 (0.00%)  0 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary Embolism  0/22 (0.00%)  0 1/21 (4.76%)  1 1/17 (5.88%)  1
Respiratory Arrest  1/22 (4.55%)  1 0/21 (0.00%)  0 0/17 (0.00%)  0
Respiratory Distress  1/22 (4.55%)  1 0/21 (0.00%)  0 0/17 (0.00%)  0
Respiratory Failure  0/22 (0.00%)  0 1/21 (4.76%)  1 2/17 (11.76%)  2
Vascular disorders       
Deep Vein Thrombosis  1/22 (4.55%)  1 0/21 (0.00%)  0 0/17 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Creatine 30gm Tamoxifen 40mg Tamoxifen 80mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/22 (95.45%)      17/21 (80.95%)      15/17 (88.24%)    
Blood and lymphatic system disorders       
Leukocytosis  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Ear and labyrinth disorders       
Tinnitus  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Eye disorders       
Dry Eye  2/22 (9.09%)  2 0/21 (0.00%)  0 1/17 (5.88%)  1
Eye Pain  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Gastrointestinal disorders       
Abdominal Distention  1/22 (4.55%)  1 0/21 (0.00%)  0 1/17 (5.88%)  1
Abdominal Pain  1/22 (4.55%)  1 0/21 (0.00%)  0 1/17 (5.88%)  1
Abdominal Pain Upper  3/22 (13.64%)  5 0/21 (0.00%)  0 1/17 (5.88%)  1
Constipation  6/22 (27.27%)  7 5/21 (23.81%)  5 3/17 (17.65%)  5
Diarrhoea  6/22 (27.27%)  7 3/21 (14.29%)  8 1/17 (5.88%)  1
Dry Mouth  1/22 (4.55%)  1 0/21 (0.00%)  0 2/17 (11.76%)  2
Dysphagia  1/22 (4.55%)  1 0/21 (0.00%)  0 2/17 (11.76%)  2
Gastrooesophageal Reflux Disease  2/22 (9.09%)  2 0/21 (0.00%)  0 1/17 (5.88%)  1
Nausea  6/22 (27.27%)  9 4/21 (19.05%)  4 2/17 (11.76%)  3
Retching  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Salivary Hypersecretion  1/22 (4.55%)  1 1/21 (4.76%)  1 1/17 (5.88%)  1
Vomiting  3/22 (13.64%)  3 1/21 (4.76%)  1 0/17 (0.00%)  0
General disorders       
Application Site Rash  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Asthenia  2/22 (9.09%)  2 0/21 (0.00%)  0 4/17 (23.53%)  4
Chills  0/22 (0.00%)  0 1/21 (4.76%)  2 1/17 (5.88%)  1
Death  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Fatigue  6/22 (27.27%)  6 4/21 (19.05%)  4 7/17 (41.18%)  7
Oedema Peripheral  4/22 (18.18%)  5 2/21 (9.52%)  2 1/17 (5.88%)  1
Thirst  2/22 (9.09%)  2 0/21 (0.00%)  0 0/17 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis Acute  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Infections and infestations       
Gastroenteritis Viral  2/22 (9.09%)  2 0/21 (0.00%)  0 0/17 (0.00%)  0
Nasopharyngitis  0/22 (0.00%)  0 1/21 (4.76%)  1 1/17 (5.88%)  1
Pneumonia  0/22 (0.00%)  0 0/21 (0.00%)  0 3/17 (17.65%)  3
Sinusitis  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Staphylococcal Infection  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Upper Respiratory Tract Infection  2/22 (9.09%)  2 0/21 (0.00%)  0 1/17 (5.88%)  1
Urinary Tract Infection  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Injury, poisoning and procedural complications       
Procedural Pain  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Ankle Fracture  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Contusion  0/22 (0.00%)  0 1/21 (4.76%)  1 1/17 (5.88%)  1
Fall  1/22 (4.55%)  2 2/21 (9.52%)  2 3/17 (17.65%)  3
Joint Injury  0/22 (0.00%)  0 2/21 (9.52%)  2 0/17 (0.00%)  0
Post Procedural Haemorrhage  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Skin Laceration  2/22 (9.09%)  2 0/21 (0.00%)  0 0/17 (0.00%)  0
Investigations       
Vital Capacity Decreased  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Weight Decreased  1/22 (4.55%)  1 1/21 (4.76%)  1 1/17 (5.88%)  1
Metabolism and nutrition disorders       
Decreased Appetite  4/22 (18.18%)  4 4/21 (19.05%)  4 1/17 (5.88%)  1
Dehydration  1/22 (4.55%)  1 0/21 (0.00%)  0 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Arthritis  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Joint Stiffness  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Mobility Decreased  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Muscle Spasms  5/22 (22.73%)  5 0/21 (0.00%)  0 1/17 (5.88%)  1
Muscular Weakness  6/22 (27.27%)  9 3/21 (14.29%)  3 2/17 (11.76%)  2
Neck Pain  1/22 (4.55%)  1 0/21 (0.00%)  0 1/17 (5.88%)  1
Pain in Extremity  2/22 (9.09%)  2 2/21 (9.52%)  2 0/17 (0.00%)  0
Pain in Jaw  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Tendonitis  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Nervous system disorders       
Burning Sensation  1/22 (4.55%)  1 0/21 (0.00%)  0 1/17 (5.88%)  1
Dizziness  3/22 (13.64%)  5 2/21 (9.52%)  4 0/17 (0.00%)  0
Dysarthria  1/22 (4.55%)  1 1/21 (4.76%)  1 1/17 (5.88%)  1
Headache  1/22 (4.55%)  2 2/21 (9.52%)  7 2/17 (11.76%)  2
Hypoaesthesia  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  2
Lethargy  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Muscle Contractions Involuntary  1/22 (4.55%)  1 0/21 (0.00%)  0 1/17 (5.88%)  1
Peroneal Nerve Palsy  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Psychiatric disorders       
Affect Lability  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Anxiety  0/22 (0.00%)  0 0/21 (0.00%)  0 2/17 (11.76%)  2
Depression  2/22 (9.09%)  2 1/21 (4.76%)  1 2/17 (11.76%)  2
Insomnia  0/22 (0.00%)  0 0/21 (0.00%)  0 2/17 (11.76%)  2
Mood Swings  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Renal and urinary disorders       
Nephrolithiasis  2/22 (9.09%)  2 0/21 (0.00%)  0 0/17 (0.00%)  0
Reproductive system and breast disorders       
Vaginal Discharge  0/22 (0.00%)  0 0/21 (0.00%)  0 2/17 (11.76%)  2
Respiratory, thoracic and mediastinal disorders       
Cough  0/22 (0.00%)  0 1/21 (4.76%)  1 1/17 (5.88%)  1
Dyspnoea  1/22 (4.55%)  1 6/21 (28.57%)  6 4/17 (23.53%)  4
Increased Bronchial Secretion  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Increased Upper Airway Secretion  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Nasal Congestion  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Oropharyngeal Pain  0/22 (0.00%)  0 1/21 (4.76%)  1 1/17 (5.88%)  1
Pulmonary Embolism  0/22 (0.00%)  0 1/21 (4.76%)  1 1/17 (5.88%)  1
Respiratory Arrest  1/22 (4.55%)  1 0/21 (0.00%)  0 1/17 (5.88%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1/22 (4.55%)  1 0/21 (0.00%)  0 1/17 (5.88%)  1
Decubitus Ulcer  0/22 (0.00%)  0 1/21 (4.76%)  1 1/17 (5.88%)  1
Hair Growth Abnormal  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Night Sweats  0/22 (0.00%)  0 1/21 (4.76%)  1 1/17 (5.88%)  1
Pruritis  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Surgical and medical procedures       
Mole Excision  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Tooth Extraction  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
Vascular disorders       
Deep Vein Thrombosis  1/22 (4.55%)  1 2/21 (9.52%)  2 1/17 (5.88%)  1
Hot Flush  0/22 (0.00%)  0 0/21 (0.00%)  0 4/17 (23.53%)  4
Hypotension  0/22 (0.00%)  0 0/21 (0.00%)  0 1/17 (5.88%)  1
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nazem Atassi, MD
Organization: Massachusetts General Hospital
Phone: 617-643-1807
EMail: natassi@partners.org
Layout table for additonal information
Responsible Party: Nazem Atassi, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01257581     History of Changes
Other Study ID Numbers: SDALS-001
First Submitted: December 8, 2010
First Posted: December 9, 2010
Results First Submitted: March 10, 2014
Results First Posted: December 4, 2014
Last Update Posted: December 4, 2014