Trial Outcomes & Findings for Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515) (NCT NCT01212445)

Results Overview

A successful BM was defined as a BM with no straining or hard/lumpy stools.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

154 participants

Primary outcome timeframe

From time of study drug treatment up to 24 hours

Results posted on

2016-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	PEG + E 13.125 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 26.25 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 39.375 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
Overall Study STARTED	52	51	51
Overall Study COMPLETED	52	51	51
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEG + E 13.125 g n=52 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment	PEG + E 26.25 g n=51 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 39.375 g n=51 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	Total n=154 Participants Total of all reporting groups
Age, Continuous	45.9 years STANDARD_DEVIATION 16.31 • n=93 Participants	50.4 years STANDARD_DEVIATION 14.27 • n=4 Participants	43.3 years STANDARD_DEVIATION 13.8 • n=27 Participants	46.5 years STANDARD_DEVIATION 14.85 • n=483 Participants
Sex: Female, Male Female	48 Participants n=93 Participants	44 Participants n=4 Participants	41 Participants n=27 Participants	133 Participants n=483 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	7 Participants n=4 Participants	10 Participants n=27 Participants	21 Participants n=483 Participants

PRIMARY outcome

Timeframe: From time of study drug treatment up to 24 hours

Population: Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.

A successful BM was defined as a BM with no straining or hard/lumpy stools.

Outcome measures

Outcome measures
Measure	PEG + E 13.125 g n=52 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 26.25 g n=51 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 39.375 g n=51 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration	19.2 percentage of participants	31.4 percentage of participants	19.2 percentage of participants

SECONDARY outcome

Timeframe: From time of study drug administration up to 3 Days

Population: Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had a successful bowel movement (no straining or hard/lumpy stools). Participants who reported no successful BMs were censored.

Time to first successful bowel movement was defined as the duration (in days) from the time of first study dose of study treatment until first successful BM (defined as BM without straining and without hard and/or lumpy stool).

Outcome measures

Outcome measures
Measure	PEG + E 13.125 g n=11 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 26.25 g n=16 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 39.375 g n=12 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration Successful BM in 0 days through 0.5 days	4 participants	8 participants	6 participants
Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration Successful BM in >0.5 days through 1.0 days	6 participants	8 participants	4 participants
Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration Successful BM in >1.0 days through 1.5 days	1 participants	0 participants	2 participants

SECONDARY outcome

Timeframe: From time of study drug treatment up to 12 hours

Population: Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.

A successful BM was defined as a BM with no straining or hard/lumpy stools.

Outcome measures

Outcome measures
Measure	PEG + E 13.125 g n=52 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 26.25 g n=51 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 39.375 g n=51 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration	7.7 percentage of participants	15.7 percentage of participants	11.8 percentage of participants

SECONDARY outcome

Timeframe: From time of study drug treatment up to 24 hours

Population: Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.

The VAS is a psychometric response scale which measures responses along a continuum of values. The BM control VAS uses a 100 mm horizontal line with the two ends representing the opposite, extreme limits of the participant's experience of BM control. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. BM Control ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=Calm, not urgent and 100 mm= Not able to hold BM, very urgent. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group

Outcome measures

Outcome measures
Measure	PEG + E 13.125 g n=36 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 26.25 g n=37 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 39.375 g n=39 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
Mean Visual Analog Scale (VAS) Rating for BM Control	31.1 mm Standard Deviation 27.27	23.5 mm Standard Deviation 23.76	29.4 mm Standard Deviation 23.59

SECONDARY outcome

Timeframe: From time of study drug treatment up to 24 hours

Population: Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.

The VAS is a psychometric response scale which measures responses along a continuum of values. The Gas VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related gas. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Gas ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.

Outcome measures

Outcome measures
Measure	PEG + E 13.125 g n=39 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 26.25 g n=40 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 39.375 g n=42 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
Mean VAS Rating for Gas	23.9 mm Standard Deviation 21.87	25.4 mm Standard Deviation 27.14	26.0 mm Standard Deviation 22.93

SECONDARY outcome

Timeframe: From time of study drug treatment up to 24 hours

Population: Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.

The VAS is a psychometric response scale which measures responses along a continuum of values. The Bloating VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related bloating. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Bloating ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.

Outcome measures

Outcome measures
Measure	PEG + E 13.125 g n=39 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 26.25 g n=38 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 39.375 g n=39 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
Mean VAS Rating for Bloating	33.9 mm Standard Deviation 32.39	21.7 mm Standard Deviation 25.10	32.7 mm Standard Deviation 29.55

SECONDARY outcome

Timeframe: From time of study drug treatment up to 24 hours

Population: Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.

The VAS is a psychometric response scale which measures responses along a continuum of values. The Abdominal Discomfort/Cramping VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related abdominal discomfort/cramping. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Abdominal discomfort/cramping ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Painful. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.

Outcome measures

Outcome measures
Measure	PEG + E 13.125 g n=37 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 26.25 g n=38 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 39.375 g n=41 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
Mean VAS Rating for Abdominal Discomfort/Cramping	17.4 mm Standard Deviation 24.91	14.0 mm Standard Deviation 22.56	14.5 mm Standard Deviation 16.89

SECONDARY outcome

Timeframe: From time of study drug administration up to 2 Days

Population: Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.

At the End of Study Visit, the study staff asked the participant to rate their global assessment of the study treatment according to the following categories: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.

Outcome measures

Outcome measures
Measure	PEG + E 13.125 g n=52 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 26.25 g n=51 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.	PEG + E 39.375 g n=51 Participants Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
Mean Participant Global Assessment of Treatment	1.0 units on a scale Standard Deviation 1.15	1.3 units on a scale Standard Deviation 1.26	1.2 units on a scale Standard Deviation 1.20

Adverse Events

PEG + E 13.125 g

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PEG + E 26.25 g

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PEG + E 39.375 g

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

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Schering-Plough HealthCare Products, Inc. reserves all publication and presentation rights.
Publication restrictions are in place

Restriction type: OTHER