Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytel... | NCT01427296

Official Title

A Phase 4, Randomized, Active Comparator, Open-Label, Multicenter Study to Assess the Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
OsmoPrep Tablets	Active Comparator		Drug: Oral sodium phosphate solution
HalfLytely and Bisacodyl Tablet	Active Comparator		Drug: Polyethylene glycol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polyethylene glycol	Drug	HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L

Outcomes Module

Measure	Description	Time Frame
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.		6 months

Eligibility Module

Contacts/Locations Module

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	OsmoPrep Tablets	Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
FG001	HalfLytely and Bisacodyl Tablet

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L

Arm/Group Information

ID	Title	Description
BG000	OsmoPrep Tablets	Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
BG001	HalfLytely and Bisacodyl Tablet	Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0001041 BG0011051 BG0022092

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Excellent	OG000618 OG001243
Good	OG000275

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	OsmoPrep Tablets	Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L			20	1,041	443	1,041
EG001	HalfLytely and Bisacodyl Tablet	Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L			19	1,051	352	1,051

Serious Adverse Events

Term	Organ System	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Angina unstable	Cardiac disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Atrial fibrillation	Cardiac disorders	EG0001 affected1,041 at risk EG0012 affected1,051 at risk
Cardiac failure congestive	Cardiac disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Coronary artery disease	Cardiac disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Ventricular tachycardia	Cardiac disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Goitre	Endocrine disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Abdominal pain	Gastrointestinal disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Abdominal pain lower	Gastrointestinal disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Colitis ischaemic	Gastrointestinal disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Colitis ulcerative	Gastrointestinal disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Colonic Fistula	Gastrointestinal disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Ileus	Gastrointestinal disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Rectal haemorrhage	Gastrointestinal disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Umbilical hernia	Gastrointestinal disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Non-cardiac chest pain	General disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Pyrexia	General disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Abdominal wall abscess	Infections and infestations	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Diverticulitis	Infections and infestations	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Gastroenteritis	Infections and infestations	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Peritoneal abscess	Infections and infestations	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Pneumonia	Infections and infestations	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Pneumonia primary atypical	Infections and infestations	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Sepsis	Infections and infestations	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Tonsillitis	Infections and infestations	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Humerus Fracture	Injury, poisoning and procedural complications	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Postoperative fever	Injury, poisoning and procedural complications	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Carcinoid tumour of the appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Large cell carcinoma of the respiratory tract stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0002 affected1,041 at risk EG0010 affected1,051 at risk
Cerebrovascular accident	Nervous system disorders	EG0001 affected1,041 at risk EG0011 affected1,051 at risk
Haemorrhagic stroke	Nervous system disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Migraine	Nervous system disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Bladder perforation	Renal and urinary disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Renal failure acute	Renal and urinary disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Angioedema	Skin and subcutaneous tissue disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Deep vein thrombosis	Vascular disorders	EG0000 affected1,041 at risk EG0011 affected1,051 at risk
Thrombosis	Vascular disorders	EG0001 affected1,041 at risk EG0010 affected1,051 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Abdominal pain	Gastrointestinal disorders	EG00012 affected1,041 at risk EG00121 affected1,051 at risk
Constipation	Gastrointestinal disorders	EG00010 affected1,041 at risk EG0016 affected1,051 at risk
Diarrhea	Gastrointestinal disorders	EG00010 affected1,041 at risk EG00112 affected1,051 at risk
Gastritis	Gastrointestinal disorders	EG00021 affected1,041 at risk EG00111 affected1,051 at risk
Nausea	Gastrointestinal disorders	EG00042 affected1,041 at risk EG00150 affected1,051 at risk
Oesophagitis	Gastrointestinal disorders	EG00010 affected1,041 at risk EG0017 affected1,051 at risk
Vomiting	Gastrointestinal disorders	EG00023 affected1,041 at risk EG00145 affected1,051 at risk
Brochitis	Infections and infestations	EG00018 affected1,041 at risk EG00115 affected1,051 at risk
Nasopharyngitis	Infections and infestations	EG0009 affected1,041 at risk EG00120 affected1,051 at risk
Sinusitis	Infections and infestations	EG00018 affected1,041 at risk EG00119 affected1,051 at risk
Upper respiratory tract infection	Infections and infestations	EG00024 affected1,041 at risk EG00125 affected1,051 at risk
Urinary tract infection	Infections and infestations	EG00034 affected1,041 at risk EG00138 affected1,051 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	EG000136 affected1,041 at risk EG0010 affected1,051 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG00033 affected1,041 at risk EG00111 affected1,051 at risk
Back pain	Musculoskeletal and connective tissue disorders	EG00013 affected1,041 at risk EG00121 affected1,051 at risk
Headache	Nervous system disorders	EG00020 affected1,041 at risk EG00116 affected1,051 at risk
Haematuria	Renal and urinary disorders	EG0008 affected1,041 at risk EG00115 affected1,051 at risk
Proteinuria	Renal and urinary disorders	EG00014 affected1,041 at risk EG0019 affected1,051 at risk
Hypertension	Vascular disorders	EG00015 affected1,041 at risk EG00111 affected1,051 at risk

Title	Organization	Phone	Extension	Email
Johnson Varughese	Valeant Pharmaceuticals	9089271400

Ancestor Terms

ID	Term
D005026	Ethylene Glycols
D006018	Glycols
D000438	Alcohols
D009930	Organic Chemicals
D011108	Polymers
D046911	Macromolecular Substances
D001697	Biomedical and Dental Materials
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture

Facility	Status	City	State	ZIP	Country	Contacts
		San Carlos	California		United States