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Trial record 8 of 413 for:    sodium phosphate

Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing

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ClinicalTrials.gov Identifier: NCT01427296
Recruitment Status : Completed
First Posted : September 1, 2011
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colon Cleansing
Interventions Drug: Polyethylene glycol
Drug: Oral sodium phosphate solution
Enrollment 2154
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OsmoPrep Tablets HalfLytely and Bisacodyl Tablet
Hide Arm/Group Description Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L 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
Period Title: Overall Study
Started 1041 1051
Completed 1041 1051
Not Completed 0 0
Arm/Group Title OsmoPrep Tablets HalfLytely and Bisacodyl Tablet Total
Hide Arm/Group Description Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L 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 Total of all reporting groups
Overall Number of Baseline Participants 1041 1051 2092
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1041 participants 1051 participants 2092 participants
<65
906
  87.0%
932
  88.7%
1838
  87.9%
>=65
135
  13.0%
119
  11.3%
254
  12.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1041 participants 1051 participants 2092 participants
Female
616
  59.2%
645
  61.4%
1261
  60.3%
Male
425
  40.8%
406
  38.6%
831
  39.7%
1.Primary Outcome
Title Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OsmoPrep Tablets HalfLytely and Bisacodyl Tablet
Hide Arm/Group Description:
Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
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
Overall Number of Participants Analyzed 1032 1040
Measure Type: Count of Participants
Unit of Measure: Participants
Excellent
618
  59.9%
243
  23.4%
Good
275
  26.6%
423
  40.7%
Fair
116
  11.2%
286
  27.5%
Inadequate
23
   2.2%
88
   8.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OsmoPrep Tablets HalfLytely and Bisacodyl Tablet
Hide Arm/Group Description Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L 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
All-Cause Mortality
OsmoPrep Tablets HalfLytely and Bisacodyl Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OsmoPrep Tablets HalfLytely and Bisacodyl Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   20/1041 (1.92%)   19/1051 (1.81%) 
Blood and lymphatic system disorders     
ANAEMIA  1/1041 (0.10%)  0/1051 (0.00%) 
Cardiac disorders     
Angina unstable  1/1041 (0.10%)  0/1051 (0.00%) 
Atrial fibrillation  1/1041 (0.10%)  2/1051 (0.19%) 
Cardiac failure congestive  0/1041 (0.00%)  1/1051 (0.10%) 
Coronary artery disease  1/1041 (0.10%)  0/1051 (0.00%) 
Ventricular tachycardia  0/1041 (0.00%)  1/1051 (0.10%) 
Endocrine disorders     
Goitre  1/1041 (0.10%)  0/1051 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  0/1041 (0.00%)  1/1051 (0.10%) 
Abdominal pain lower  0/1041 (0.00%)  1/1051 (0.10%) 
Colitis ischaemic  1/1041 (0.10%)  0/1051 (0.00%) 
Colitis ulcerative  1/1041 (0.10%)  0/1051 (0.00%) 
Colonic Fistula  1/1041 (0.10%)  0/1051 (0.00%) 
Gastrointestinal haemorrhage  0/1041 (0.00%)  1/1051 (0.10%) 
Ileus  1/1041 (0.10%)  0/1051 (0.00%) 
Mesenteric vein thrombosis  1/1041 (0.10%)  0/1051 (0.00%) 
Rectal haemorrhage  0/1041 (0.00%)  1/1051 (0.10%) 
Umbilical hernia  0/1041 (0.00%)  1/1051 (0.10%) 
General disorders     
Non-cardiac chest pain  0/1041 (0.00%)  1/1051 (0.10%) 
Pyrexia  0/1041 (0.00%)  1/1051 (0.10%) 
Infections and infestations     
Abdominal wall abscess  1/1041 (0.10%)  0/1051 (0.00%) 
Diverticulitis  1/1041 (0.10%)  0/1051 (0.00%) 
Gastroenteritis  1/1041 (0.10%)  0/1051 (0.00%) 
Peritoneal abscess  1/1041 (0.10%)  0/1051 (0.00%) 
Pneumonia  0/1041 (0.00%)  1/1051 (0.10%) 
Pneumonia primary atypical  1/1041 (0.10%)  0/1051 (0.00%) 
Sepsis  1/1041 (0.10%)  0/1051 (0.00%) 
Tonsillitis  0/1041 (0.00%)  1/1051 (0.10%) 
Injury, poisoning and procedural complications     
Abdominal wound dehiscence  1/1041 (0.10%)  0/1051 (0.00%) 
Gastrointestinal anastomotic leak  1/1041 (0.10%)  0/1051 (0.00%) 
Humerus Fracture  0/1041 (0.00%)  1/1051 (0.10%) 
Postoperative fever  0/1041 (0.00%)  1/1051 (0.10%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1/1041 (0.10%)  0/1051 (0.00%) 
Hypokalaemia  0/1041 (0.00%)  1/1051 (0.10%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  0/1041 (0.00%)  1/1051 (0.10%) 
Osteoarthritis  1/1041 (0.10%)  0/1051 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  0/1041 (0.00%)  1/1051 (0.10%) 
Carcinoid tumour of the appendix  1/1041 (0.10%)  0/1051 (0.00%) 
Colon adenoma  1/1041 (0.10%)  0/1051 (0.00%) 
Large cell carcinoma of the respiratory tract stage unspecified  0/1041 (0.00%)  1/1051 (0.10%) 
Non-small cell lung cancer  0/1041 (0.00%)  1/1051 (0.10%) 
Ovarian adenoma  0/1041 (0.00%)  1/1051 (0.10%) 
Renal cell carcinoma  2/1041 (0.19%)  0/1051 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1/1041 (0.10%)  1/1051 (0.10%) 
Haemorrhagic stroke  1/1041 (0.10%)  0/1051 (0.00%) 
Migraine  0/1041 (0.00%)  1/1051 (0.10%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1/1041 (0.10%)  0/1051 (0.00%) 
Renal and urinary disorders     
Bladder perforation  0/1041 (0.00%)  1/1051 (0.10%) 
Renal failure acute  1/1041 (0.10%)  0/1051 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1/1041 (0.10%)  0/1051 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax  0/1041 (0.00%)  1/1051 (0.10%) 
Pulmonary embolism  0/1041 (0.00%)  1/1051 (0.10%) 
Skin and subcutaneous tissue disorders     
Angioedema  0/1041 (0.00%)  1/1051 (0.10%) 
Vascular disorders     
Deep vein thrombosis  0/1041 (0.00%)  1/1051 (0.10%) 
Thrombosis  1/1041 (0.10%)  0/1051 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
OsmoPrep Tablets HalfLytely and Bisacodyl Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   443/1041 (42.56%)   352/1051 (33.49%) 
Gastrointestinal disorders     
Abdominal pain  12/1041 (1.15%)  21/1051 (2.00%) 
Constipation  10/1041 (0.96%)  6/1051 (0.57%) 
Diarrhea  10/1041 (0.96%)  12/1051 (1.14%) 
Gastritis  21/1041 (2.02%)  11/1051 (1.05%) 
Nausea  42/1041 (4.03%)  50/1051 (4.76%) 
Oesophagitis  10/1041 (0.96%)  7/1051 (0.67%) 
Vomiting  23/1041 (2.21%)  45/1051 (4.28%) 
Infections and infestations     
Brochitis  18/1041 (1.73%)  15/1051 (1.43%) 
Nasopharyngitis  9/1041 (0.86%)  20/1051 (1.90%) 
Sinusitis  18/1041 (1.73%)  19/1051 (1.81%) 
Upper respiratory tract infection  24/1041 (2.31%)  25/1051 (2.38%) 
Urinary tract infection  34/1041 (3.27%)  38/1051 (3.62%) 
Metabolism and nutrition disorders     
Hyperphosphataemia  136/1041 (13.06%)  0/1051 (0.00%) 
Hypokalaemia  33/1041 (3.17%)  11/1051 (1.05%) 
Musculoskeletal and connective tissue disorders     
Back pain  13/1041 (1.25%)  21/1051 (2.00%) 
Nervous system disorders     
Headache  20/1041 (1.92%)  16/1051 (1.52%) 
Renal and urinary disorders     
Haematuria  8/1041 (0.77%)  15/1051 (1.43%) 
Proteinuria  14/1041 (1.34%)  9/1051 (0.86%) 
Vascular disorders     
Hypertension  15/1041 (1.44%)  11/1051 (1.05%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Johnson Varughese
Organization: Valeant Pharmaceuticals
Phone: 9089271400
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01427296     History of Changes
Other Study ID Numbers: OSBP4011
First Submitted: August 30, 2011
First Posted: September 1, 2011
Results First Submitted: December 20, 2017
Results First Posted: January 18, 2018
Last Update Posted: January 18, 2018