Trial Outcomes & Findings for Small Volume Simethicone Before Gastroscopy: Any Benefit? (NCT NCT02555228)

Results Overview

Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score: Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured Total areas covered: (E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

54 participants

Primary outcome timeframe

This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

Results posted on

2016-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Simethicone Premedication Liquid simethicone (1ml volume) in 5mls of water Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.	Placebo Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
Overall Study STARTED	27	27
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Small Volume Simethicone Before Gastroscopy: Any Benefit?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simethicone Premedication n=27 Participants Liquid simethicone (1ml volume) in 5mls of water Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.	Placebo n=27 Participants Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy.	Total n=54 Participants Total of all reporting groups
Age, Customized Age	57.7 years STANDARD_DEVIATION 12.5 • n=5 Participants	52.9 years STANDARD_DEVIATION 15.5 • n=7 Participants	55.3 years STANDARD_DEVIATION 14 • n=5 Participants
Sex/Gender, Customized Male patients	15 participants n=5 Participants	9 participants n=7 Participants	24 participants n=5 Participants
Sex/Gender, Customized Female patients	12 participants n=5 Participants	18 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment Singapore	27 participants n=5 Participants	27 participants n=7 Participants	54 participants n=5 Participants
Mean premedication time (min:sec)	2686 seconds STANDARD_DEVIATION 756 • n=5 Participants	2468 seconds STANDARD_DEVIATION 596 • n=7 Participants	2577 seconds STANDARD_DEVIATION 676 • n=5 Participants

PRIMARY outcome

Timeframe: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score: Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured Total areas covered: (E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus

Outcome measures

Outcome measures
Measure	Simethicone Premedication n=27 Participants Liquid simethicone (1ml volume) in 5mls of water Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.	Placebo n=27 Participants Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
Total Cumulative Mucosal Visibility Score	5.78 units Standard Deviation 1.65	8.89 units Standard Deviation 1.97

SECONDARY outcome

Timeframe: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

* Area E: esophagus * Area D: duodenum * Area A: antrum and angularis * Area B: body and fundus Mc Nally score per area: Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured

Outcome measures

Outcome measures
Measure	Simethicone Premedication n=27 Participants Liquid simethicone (1ml volume) in 5mls of water Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.	Placebo n=27 Participants Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
Mucosal Visibility Score Per Area as Determined by Mc Nally Score: Area E (esopahgus)	1.48 units on a scale Standard Deviation 0.57	1.59 units on a scale Standard Deviation 0.57
Mucosal Visibility Score Per Area as Determined by Mc Nally Score: Area D (duodenum)	1.26 units on a scale Standard Deviation 0.53	2.26 units on a scale Standard Deviation 0.81
Mucosal Visibility Score Per Area as Determined by Mc Nally Score: Area A (antrum and angularis)	1.30 units on a scale Standard Deviation 0.54	2.56 units on a scale Standard Deviation 1.05
Mucosal Visibility Score Per Area as Determined by Mc Nally Score: Area B (body and fundus)	1.74 units on a scale Standard Deviation 0.81	2.44 units on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.

Outcome measures

Outcome measures
Measure	Simethicone Premedication n=27 Participants Liquid simethicone (1ml volume) in 5mls of water Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.	Placebo n=27 Participants Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
Volume of Additional Manual Flushes Required During Endoscopy in Mls	3.89 mls Standard Deviation 11.46	84.81 mls Standard Deviation 110.18

SECONDARY outcome

Timeframe: Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours

Outcome measures

Outcome measures
Measure	Simethicone Premedication n=27 Participants Liquid simethicone (1ml volume) in 5mls of water Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.	Placebo n=27 Participants Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution	0 number of events	0 number of events

Adverse Events

Simethicone Premedication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Song Mingjun

MOHH Holdings

Phone: 86337635

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place