Trial Outcomes & Findings for Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing (NCT NCT01427296)
NCT ID: NCT01427296
Last Updated: 2018-01-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2154 participants
Primary outcome timeframe
6 months
Results posted on
2018-01-18
Participant Flow
Participant milestones
| Measure |
OsmoPrep Tablets
Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
1041
|
1051
|
|
Overall Study
COMPLETED
|
1041
|
1051
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Baseline characteristics by cohort
| Measure |
OsmoPrep Tablets
n=1041 Participants
Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
|
HalfLytely and Bisacodyl Tablet
n=1051 Participants
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
n=2092 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65
|
906 Participants
n=5 Participants
|
932 Participants
n=7 Participants
|
1838 Participants
n=5 Participants
|
|
Age, Customized
>=65
|
135 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
616 Participants
n=5 Participants
|
645 Participants
n=7 Participants
|
1261 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
425 Participants
n=5 Participants
|
406 Participants
n=7 Participants
|
831 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
OsmoPrep Tablets
n=1032 Participants
Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
|
HalfLytely and Bisacodyl Tablet
n=1040 Participants
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
|
|---|---|---|
|
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
Excellent
|
618 Participants
|
243 Participants
|
|
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
Good
|
275 Participants
|
423 Participants
|
|
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
Fair
|
116 Participants
|
286 Participants
|
|
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
Inadequate
|
23 Participants
|
88 Participants
|
Adverse Events
OsmoPrep Tablets
Serious events: 20 serious events
Other events: 443 other events
Deaths: 0 deaths
HalfLytely and Bisacodyl Tablet
Serious events: 19 serious events
Other events: 352 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OsmoPrep Tablets
n=1041 participants at risk
Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
|
HalfLytely and Bisacodyl Tablet
n=1051 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Cardiac disorders
Angina unstable
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Cardiac disorders
Atrial fibrillation
|
0.10%
1/1041
|
0.19%
2/1051
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Cardiac disorders
Coronary artery disease
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Endocrine disorders
Goitre
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Gastrointestinal disorders
Colonic Fistula
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Gastrointestinal disorders
Ileus
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1041
|
0.10%
1/1051
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1041
|
0.10%
1/1051
|
|
General disorders
Pyrexia
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Infections and infestations
Abdominal wall abscess
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Infections and infestations
Diverticulitis
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Infections and infestations
Peritoneal abscess
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Infections and infestations
Pneumonia primary atypical
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Infections and infestations
Sepsis
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the appendix
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell carcinoma of the respiratory tract stage unspecified
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.19%
2/1041
|
0.00%
0/1051
|
|
Nervous system disorders
Cerebrovascular accident
|
0.10%
1/1041
|
0.10%
1/1051
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Nervous system disorders
Migraine
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Renal and urinary disorders
Renal failure acute
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.10%
1/1041
|
0.00%
0/1051
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1041
|
0.10%
1/1051
|
|
Vascular disorders
Thrombosis
|
0.10%
1/1041
|
0.00%
0/1051
|
Other adverse events
| Measure |
OsmoPrep Tablets
n=1041 participants at risk
Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
|
HalfLytely and Bisacodyl Tablet
n=1051 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
12/1041
|
2.0%
21/1051
|
|
Gastrointestinal disorders
Constipation
|
0.96%
10/1041
|
0.57%
6/1051
|
|
Gastrointestinal disorders
Diarrhea
|
0.96%
10/1041
|
1.1%
12/1051
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
21/1041
|
1.0%
11/1051
|
|
Gastrointestinal disorders
Nausea
|
4.0%
42/1041
|
4.8%
50/1051
|
|
Gastrointestinal disorders
Oesophagitis
|
0.96%
10/1041
|
0.67%
7/1051
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
23/1041
|
4.3%
45/1051
|
|
Infections and infestations
Brochitis
|
1.7%
18/1041
|
1.4%
15/1051
|
|
Infections and infestations
Nasopharyngitis
|
0.86%
9/1041
|
1.9%
20/1051
|
|
Infections and infestations
Sinusitis
|
1.7%
18/1041
|
1.8%
19/1051
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
24/1041
|
2.4%
25/1051
|
|
Infections and infestations
Urinary tract infection
|
3.3%
34/1041
|
3.6%
38/1051
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
13.1%
136/1041
|
0.00%
0/1051
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.2%
33/1041
|
1.0%
11/1051
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
13/1041
|
2.0%
21/1051
|
|
Nervous system disorders
Headache
|
1.9%
20/1041
|
1.5%
16/1051
|
|
Renal and urinary disorders
Haematuria
|
0.77%
8/1041
|
1.4%
15/1051
|
|
Renal and urinary disorders
Proteinuria
|
1.3%
14/1041
|
0.86%
9/1051
|
|
Vascular disorders
Hypertension
|
1.4%
15/1041
|
1.0%
11/1051
|
Additional Information
Johnson Varughese
Valeant Pharmaceuticals
Phone: 9089271400
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place