Safety Study of SPARC1104 | NCT01797185

NCT01797185

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
SPARC1104 group 1	Experimental	Drug: SPARC1104 modified dose regimen I
SPARC1104 group 2	Experimental	Drug: SPARC1104 modified dose regimen II
SPARC1104 group 3	Experimental	Drug: SPARC1104 modified dose regimen III

Name	Type	Description	Arm Group Labels	Other Names
SPARC1104 modified dose regimen I	Drug	Subjects who exited study CLR_09_21	SPARC1104 group 1

Outcomes Module

Measure	Description	Time Frame
Number of Subjects With Adverse Events		52 weeks

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
SPARC site 4		Gilbert	Arizona	85234	United States
SPARC Site 34

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SPARC1104 Group 1	Subjects who completed Part 3 of Study CLR_09_21 Dose: One or two capsules once daily
FG001	SPARC1104 Group 2	Subjects who are on Dose regimen I of SPARC0921 at entry. Dose: One or two capsules once daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 17, 2015	Dec 18, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	SPARC1104 Group 1	Subjects who completed Study CLR_09_21
BG001	SPARC1104 Group 2	Subjects who are on Dose regimen I of SPARC0921 at entry
BG002	SPARC1104 Group 3	Subjects Entering the Trial with no Prior Treatment with SPARC0921
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00051.7± 9.56 BG00152.9± 9.77 BG00251.3± 11.55 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000119 BG001116 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0007 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Adverse Events

Safety population: Subject who received at least one dose of study treatment

Posted

Number

Count of participants

52 weeks

ID	Title	Description
OG000	SPARC1104 Group 1	Subjects who completed Study CLR_09_21
OG001	SPARC1104 Group 2	Subjects who are on Dose regimen I of SPARC0921 at entry
OG002	SPARC1104 Group 3	Subjects Entering the Trial with no Prior Treatment with SPARC0921

Units	Counts
Participants	OG000162 OG001163 OG00250

Title

Denominators

Categories

Title	Measurements
	OG000129 OG001150 OG00244

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SPARC1104 Group 1	Subjects who completed Study CLR_09_21	162	30	162	129	162
EG001	SPARC1104 Group 2	Subjects who are on Dose regimen I of SPARC0921 at entry	163	40	163	150	163
EG002	SPARC1104 Group 3	Subjects Entering the Trial with no Prior Treatment with SPARC0921	50	6	50	44	50

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Stress cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Goitre	Endocrine disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Abdominal hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0021 affected50 at risk
Acquired oesophageal web	Gastrointestinal disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected162 at risk EG0010 affected163 at risk EG0021 affected50 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected162 at risk EG0011 affected163 at risk EG0022 affected50 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected162 at risk EG0010 affected163 at risk EG0021 affected50 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Multiple sclerosis relapse	Nervous system disorders	Systematic Assessment	EG0004 affected162 at risk EG0015 affected163 at risk EG0020 affected50 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0001 affected162 at risk EG0012 affected163 at risk EG0020 affected50 at risk
Partial seizures	Nervous system disorders	Systematic Assessment	EG0001 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Aphasia	Nervous system disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Complex partial seizures	Nervous system disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Convulsion	Nervous system disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Lumbar radiculopathy	Nervous system disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Migraine	Nervous system disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Trigeminal neuralgia	Nervous system disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Mental status changes	Psychiatric disorders	Systematic Assessment	EG0003 affected162 at risk EG0015 affected163 at risk EG0020 affected50 at risk
Delirium	Psychiatric disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Psychotic disorder	Psychiatric disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Stress	Psychiatric disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Suicide attempt	Psychiatric disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0021 affected50 at risk
Renal failure acute	Renal and urinary disorders	Systematic Assessment	EG0002 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Ovarian cyst	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Rectocele	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Testicular torsion	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected162 at risk EG0010 affected163 at risk EG0021 affected50 at risk
Accidental overdose	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Ankle fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Femur fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Fibula fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Liver function test abnormal	Investigations	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Asthenia	General disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Chest pain	General disorders	Systematic Assessment	EG0000 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Pyrexia	General disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0002 affected162 at risk EG0011 affected163 at risk EG0020 affected50 at risk
Cholecystitis acute	Hepatobiliary disorders	Systematic Assessment	EG0000 affected162 at risk EG0012 affected163 at risk EG0020 affected50 at risk
Biliary dyskinesia	Hepatobiliary disorders	Systematic Assessment	EG0001 affected162 at risk EG0010 affected163 at risk EG0020 affected50 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Headache	Nervous system disorders	Systematic Assessment	EG00026 affected162 at risk EG00131 affected163 at risk EG00211 affected50 at risk
Multiple sclerosis relapse	Nervous system disorders	Systematic Assessment	EG00029 affected162 at risk EG00130 affected163 at risk EG0027 affected50 at risk
Muscle spasticity	Nervous system disorders	Systematic Assessment	EG00024 affected162 at risk EG00132 affected163 at risk EG0029 affected50 at risk
Urinary tract infection	Nervous system disorders	Systematic Assessment	EG00032 affected162 at risk EG00121 affected163 at risk EG0025 affected50 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00014 affected162 at risk EG00135 affected163 at risk EG0024 affected50 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00019 affected162 at risk EG00124 affected163 at risk EG0027 affected50 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00017 affected162 at risk EG00126 affected163 at risk EG0024 affected50 at risk
Fatigue	General disorders	Systematic Assessment	EG00016 affected162 at risk EG00125 affected163 at risk EG0025 affected50 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG00011 affected162 at risk EG00122 affected163 at risk EG00211 affected50 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG00020 affected162 at risk EG00122 affected163 at risk EG0022 affected50 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG00013 affected162 at risk EG00123 affected163 at risk EG0028 affected50 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00014 affected162 at risk EG00123 affected163 at risk EG0025 affected50 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00016 affected162 at risk EG00120 affected163 at risk EG0025 affected50 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00016 affected162 at risk EG00119 affected163 at risk EG0024 affected50 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00016 affected162 at risk EG00114 affected163 at risk EG0025 affected50 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 affected162 at risk EG00122 affected163 at risk EG0022 affected50 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0007 affected162 at risk EG00116 affected163 at risk EG0024 affected50 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG00010 affected162 at risk EG00115 affected163 at risk EG0022 affected50 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG00011 affected162 at risk EG00111 affected163 at risk EG0022 affected50 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG00010 affected162 at risk EG00112 affected163 at risk EG0020 affected50 at risk
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0007 affected162 at risk EG0019 affected163 at risk EG0025 affected50 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG00012 affected162 at risk EG0017 affected163 at risk EG0022 affected50 at risk
Asthenia	General disorders	Systematic Assessment	EG0009 affected162 at risk EG0019 affected163 at risk EG0022 affected50 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 affected162 at risk EG00110 affected163 at risk EG0021 affected50 at risk
Oedema peripheral	General disorders	Systematic Assessment	EG0008 affected162 at risk EG00111 affected163 at risk EG0021 affected50 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0008 affected162 at risk EG0018 affected163 at risk EG0023 affected50 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 affected162 at risk EG00110 affected163 at risk EG0020 affected50 at risk

ID	Term
D009128	Muscle Spasticity

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009122	Muscle Hypertonia
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms