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Trial record 81 of 180 for:    ERYTHROMYCIN

Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02481219
Recruitment Status : Completed
First Posted : June 25, 2015
Results First Posted : July 11, 2016
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Colorectal Cancer Screening
Interventions Device: PillCam® COLON 2 procedure-CONTROL
Drug: Senna tablets
Drug: PEG
Drug: Metoclopramide
Drug: Erythromycin
Drug: SUPREP oral sulfate solution
Drug: Bisacodyl
Drug: SUPREP oral sulfate solution with Gastrografin
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test
Hide Arm/Group Description

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Period Title: Overall Study
Started 60 62
Completed 58 61
Not Completed 2 1
Arm/Group Title Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test Total
Hide Arm/Group Description

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Total of all reporting groups
Overall Number of Baseline Participants 60 62 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 122 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
58
  96.7%
56
  90.3%
114
  93.4%
>=65 years
2
   3.3%
6
   9.7%
8
   6.6%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants 62 participants 122 participants
53
(50 to 67)
53
(50 to 68)
53
(50 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 122 participants
Female
31
  51.7%
34
  54.8%
65
  53.3%
Male
29
  48.3%
28
  45.2%
57
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 62 participants 122 participants
60 62 122
1.Primary Outcome
Title Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Hide Description The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).
Time Frame Within two weeks of study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.
Arm/Group Title Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test
Hide Arm/Group Description:

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Overall Number of Participants Analyzed 44 54
Measure Type: Number
Unit of Measure: percentage of particpants
Overall Excellent cleansing 6.8 16.7
Cecum Excellent cleansing 14.0 14.6
Ascending Excellent cleansing 12.2 18.2
Transverse Excellent cleansing 10.6 14.6
Descending Excellent cleansing 9.5 18.5
Rectum Excellent cleansing 0 10
Overall Good cleansing 70.5 59.3
Cecum Good cleansing 54.0 52.7
Ascending Good cleansing 63.3 60.0
Transverse Good cleansing 61.7 60.0
Descending Good cleansing 73.8 63.0
Rectum Good cleansing 56.1 52.0
Overall Fair cleansing 22.7 24.1
Cecum Fair cleansing 30.0 30.9
Ascending Fair cleansing 22.5 21.8
Transverse Fair cleansing 27.7 25.5
Descending Fair cleansing 16.7 18.5
Rectum Fair cleansing 46.5 36.0
Overall Poor cleansing 0 0
Cecum Poor cleansing 2.0 1.8
Ascending Poor cleansing 2.0 0
Transverse Poor cleansing 0 0
Descending Poor cleansing 0 0
Rectum Poor cleansing 2.4 2.0
2.Secondary Outcome
Title Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Hide Description Will be assessed from RAPID video in total and by segment
Time Frame an expected average of 3 weeks from study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.
Arm/Group Title Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test
Hide Arm/Group Description:

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Overall Number of Participants Analyzed 47 55
Measure Type: Number
Unit of Measure: percentage of participants
Overall (any size) 46.8 58.2
Cecum (any size) 6.0 14.6
Ascending (any size) 14.0 9.1
Transverse (any size) 4.3 7.3
Descending (any size) 31.9 29.1
rectum (any size) 24.4 32.0
Overall (polyps ≥6mm) 21.3 36.4
Cecum (polyps ≥6mm) 2.0 12.7
Ascending (polyps ≥6mm) 2.0 3.6
Transverse (polyps ≥6mm) 4.3 7.3
Descending (polyps ≥6mm) 12.8 16.4
Rectum (polyps ≥6mm) 7.3 6.0
Overall (polyps ≥10mm) 8.5 14.6
Cecum Overall (polyps ≥10mm) 0 7.3
Ascending Overall (polyps ≥10mm) 2.0 3.6
Transverse (polyps ≥10mm) 0 1.8
Descending (polyps ≥10mm) 4.3 3.6
Rectum (polyps ≥10mm) 4.9 2.0
3.Secondary Outcome
Title Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE
Hide Description Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment
Time Frame an expected average of 3 weeks from study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.
Arm/Group Title Bowel Preparation Regimen - Control Bowel Preparation Regimen-Test
Hide Arm/Group Description:

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure- Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Overall Number of Participants Analyzed 46 55
Median (Full Range)
Unit of Measure: hours
2.8
(0.4 to 7.5)
2.4
(0 to 5.5)
4.Secondary Outcome
Title Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE
Hide Description Will be assessed from RAPID video in total and by segment
Time Frame an expected average of 3 weeks from study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis set
Arm/Group Title Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test
Hide Arm/Group Description:

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure- Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Overall Number of Participants Analyzed 52 55
Measure Type: Number
Unit of Measure: percentage of participants
76.9 90.9
5.Secondary Outcome
Title Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE
Hide Description Will be assesses by applicable case report form (CRF)
Time Frame an expected average of 3 weeks from study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake <1h and > 2.15h, Morning PEG intake <1h and >2:15 h, Capsule ingestion l<45 min or >75 min after PEG intake , Overall PEG intake volume is less than 3 liters
Arm/Group Title Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test
Hide Arm/Group Description:

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Overall Number of Participants Analyzed 51 55
Measure Type: Number
Unit of Measure: percentage of participants
80.4 90.9
6.Secondary Outcome
Title Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE
Hide Description Will be assesses by applicable CRF
Time Frame Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test
Hide Arm/Group Description:

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Overall Number of Participants Analyzed 59 62
Measure Type: Number
Unit of Measure: percentage of participants with >1 AE
3.4 19.4
Time Frame Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test
Hide Arm/Group Description

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

All-Cause Mortality
Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/59 (0.00%)      1/62 (1.61%)    
Eye disorders     
Chronic Sinusitis  1 [1]  0/59 (0.00%)  0 1/62 (1.61%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
[1]
Subject experienced double vision and swollen eye and was hospitalized. He was scheduled to undergo Functional Endonasal sinus surgery.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bowel Preparation Regimen -Control Bowel Preparation Regimen-Test
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/59 (3.39%)      12/62 (19.35%)    
Ear and labyrinth disorders     
Eye swelling  1  0/59 (0.00%)  0 1/62 (1.61%)  1
Gastrointestinal disorders     
abdominal pain  1  2/59 (3.39%)  3 1/62 (1.61%)  1
Diarrhoea  1  0/59 (0.00%)  0 1/62 (1.61%)  1
Dyspesia  1  0/59 (0.00%)  0 1/62 (1.61%)  1
Haemorrhoids  1  0/59 (0.00%)  0 1/62 (1.61%)  1
Nausea  1  0/59 (0.00%)  0 4/62 (6.45%)  4
Proctalgia  1  0/59 (0.00%)  0 1/62 (1.61%)  1
vomiting  1  0/59 (0.00%)  0 2/62 (3.23%)  3
General disorders     
Irritation  1 [1]  0/59 (0.00%)  0 2/62 (3.23%)  2
Injury, poisoning and procedural complications     
Muscle strain  1 [2]  0/59 (0.00%)  0 1/62 (1.61%)  1
Nervous system disorders     
Haedache  1  1/59 (1.69%)  1 2/62 (3.23%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
[1]
Skin irritation
[2]
Muscle strain
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.
Prior written consent is required for PI to independently publish any study results before a multi-center publication is released. If a multi-center manuscript is not submitted for publication within 1 year after completion of the Trial, PI shall have the right to Publish results. Sponsor shall respond within 45 days and shall have the right to delay the Publication for an additional 90.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Liron Bar Yaakov
Organization: Given Imaging (a Medtronic company)
Phone: +97249097946
EMail: liron.bar-yaakov@covidien.com
Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02481219     History of Changes
Other Study ID Numbers: MA-205
First Submitted: May 19, 2015
First Posted: June 25, 2015
Results First Submitted: March 6, 2016
Results First Posted: July 11, 2016
Last Update Posted: March 7, 2017