Open-Label Study of Teduglutide for Subjects With PN-Depe... | NCT00930644

ID	Type	Description	Link
2009-011679-65	EudraCT Number

Name	Class
Nycomed Germany GmbH	INDUSTRY

Label	Type	Description	Intervention Names
teduglutide	Experimental	0.05 mg/kg/day	Drug: teduglutide

Name	Type	Description	Arm Group Labels	Other Names
teduglutide	Drug	0.05 mg/kg/day subcutaneously taken once per day for 24 months	teduglutide

Measure	Description	Time Frame
Percent Change in PN/IV Volume by Visit	The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.	24 months
Absolute Change in PN/IV Volume by Visit	The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.	24 months

Measure	Description	Time Frame
Number of Subjects Achieving PN/IV Reduction	The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.	24 Months or Last Dosing Visit

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Clinic & Research Foundation		La Jolla	California	92037	United States
Mount Sinai Medical Center

PubMed Identifier	Type	Citation	Retractions
16099790	Background	Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31. doi: 10.1136/gut.2004.061440.
32341691

ID	Title	Description
FG000	Teduglutide 0.05 mg/kg/Day	teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months

ID	Title	Description
BG000	Teduglutide 0.05 mg/kg/Day	teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months

Units	Counts
Participants	BG00088

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

Percent Change in PN/IV Volume by Visit

The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.

Posted

Mean

Standard Deviation

percent change

24 months

ID	Title	Description
OG000	NT/TED	No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
OG001	PBO/TED	Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
OG002	TED/TED	0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial

Units	Counts
Participants	OG00012 OG00139 OG00237

Title

Denominators

Categories

Month 1

Title	Measurements
	OG000-5.35± 11.287 OG001-6.44± 11.241 OG002-40.65± 21.546

Month 2

Primary

Absolute Change in PN/IV Volume by Visit

The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.

Posted

Mean

Standard Deviation

Liters

24 months

ID	Title	Description
OG000	NT/TED	No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
OG001	PBO/TED	Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
OG002	TED/TED	0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial

Units	Counts
Participants	OG000

Secondary

Number of Subjects Achieving PN/IV Reduction

The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.

Posted

Number

participants

24 Months or Last Dosing Visit

ID	Title	Description
OG000	NT/TED	No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
OG001	PBO/TED	Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
OG002	TED/TED	0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Crohns disease	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events1 affected51 at risk EG0011 events1 affected37 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Fecal volume increased	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Melena	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Papilla of Vater stenosis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Pyrexia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events4 affected51 at risk EG0011 events1 affected37 at risk
Face oedema	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Injection site haematoma	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Soft tissue inflammation	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Portal hypertension	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Central line infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0005 events3 affected51 at risk EG0017 events5 affected37 at risk
Catheter bacteraemia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0007 events4 affected51 at risk EG0010 events0 affected37 at risk
Catheter sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected51 at risk EG0011 events1 affected37 at risk
Sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected51 at risk EG0011 events1 affected37 at risk
Catheter related infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0012 events2 affected37 at risk
Pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0012 events2 affected37 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0014 events3 affected37 at risk
Catheter site infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0013 events2 affected37 at risk
Gastroenteritis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events2 affected37 at risk
Bacteraemia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Brain abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Catheter site cellulitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events1 affected51 at risk EG0010 events0 affected37 at risk
Clostridial infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Diverticulitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events1 affected37 at risk
Hepatic cyst infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Herpes Zoster	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Intervertebral discitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Sepsis syndrome	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Tuberculosis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected51 at risk EG0010 events0 affected37 at risk
Chemical burn of the eye	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Device breakage	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Blood bilirubin increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0011 events1 affected37 at risk
Alanine aminotransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Gamma glutamyltransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events1 affected37 at risk
Syncope	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Delusional disorder, unspecified type	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Suicide attempt	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Renal colic	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events1 affected51 at risk EG0010 events0 affected37 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0011 events1 affected37 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Haematoma	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected37 at risk
Superior vena caval stenosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected37 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Blood and Lymphatic System Disorders	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment		EG00010 events5 affected51 at risk EG0015 events3 affected37 at risk
Gastrointestinal Disorders	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	Includes abdominal pain, nausea, abdominal distension, diarrhea, flatulence, vomiting, abdominal pain upper, dyspepsia, abdominal discomfort, constipation, faecal volume increased, intestinal obstruction, abdominal pain lower, and others.	EG000148 events34 affected51 at risk EG00168 events20 affected37 at risk
General Disorders, and Administration Site Conditions	General disorders	MedDRA (12.0)	Systematic Assessment		EG000100 events27 affected51 at risk EG00140 events15 affected37 at risk
Hepatobiliary Disorders	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment		EG00010 events8 affected51 at risk EG0012 events2 affected37 at risk
Infections and Infestations	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG00097 events31 affected51 at risk EG00162 events26 affected37 at risk
Injury, Poisoning, and Procedural Complications	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG00039 events19 affected51 at risk EG00139 events13 affected37 at risk
Investigations	Investigations	MedDRA (12.0)	Systematic Assessment		EG00062 events22 affected51 at risk EG00131 events19 affected37 at risk
Metabolism and Nutrition Disorder	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment		EG00044 events14 affected51 at risk EG00133 events14 affected37 at risk
Musculoskeletal and Connective Tissue Disorders	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG00037 events11 affected51 at risk EG00123 events13 affected37 at risk
Nervous System Disorders	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG00060 events10 affected51 at risk EG00118 events10 affected37 at risk
Psychiatric Disorders	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG00011 events8 affected51 at risk EG0012 events2 affected37 at risk
Renal and Urinary Disorders	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment		EG00017 events6 affected51 at risk EG00117 events4 affected37 at risk
Respiratory, Thoracic, and Mediastinal Disorders	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG00020 events10 affected51 at risk EG0019 events7 affected37 at risk
Vascular Disorder	Vascular disorders	MedDRA (12.0)	Systematic Assessment		EG00018 events14 affected51 at risk EG00116 events6 affected37 at risk

ID	Term
D012778	Short Bowel Syndrome
D006963	Hyperphagia

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NT,PBO/TED	No treatment or placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial			32	51	49	51
EG001	TED/TED	0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial			24	37	35	37