Trial Outcomes & Findings for Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation (MK-8114-003) (NCT NCT01885104)

Last Updated: 2015-03-11

Results Overview

Participants underwent visual examination of the oral muscosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment

Results posted on

2015-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	PEG 3350 Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.	Placebo Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
Overall Study STARTED	31	34
Overall Study COMPLETED	29	33
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	PEG 3350 Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.	Placebo Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
Overall Study Withdrawal of Consent	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	1	0

Baseline Characteristics

Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation (MK-8114-003)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEG 3350 n=31 Participants Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.	Placebo n=34 Participants Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.	Total n=65 Participants Total of all reporting groups
Age, Continuous	44.5 Years STANDARD_DEVIATION 13.87 • n=5 Participants	48.0 Years STANDARD_DEVIATION 15.17 • n=7 Participants	46.4 Years STANDARD_DEVIATION 14.56 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment

Population: Safety Population, which consisted of all participants who received at least 1 dose of PEG 3350 or placebo and had at least 1 postdose safety assessment.

Outcome measures

Outcome measures
Measure	PEG 3350 n=31 Participants Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.	Placebo n=34 Participants Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
Number of Participants With Inflammation of the Oral Mucosa Visit 2: 0=No inflammation	31 Particpants	34 Particpants
Number of Participants With Inflammation of the Oral Mucosa Visit 2: 1=Mild inflammation	0 Particpants	0 Particpants
Number of Participants With Inflammation of the Oral Mucosa Visit 2: 2=Moderate inflammation	0 Particpants	0 Particpants
Number of Participants With Inflammation of the Oral Mucosa Visit 2: 3=Severe inflammation	0 Particpants	0 Particpants
Number of Participants With Inflammation of the Oral Mucosa Visit 2: Not evaluated	0 Particpants	0 Particpants
Number of Participants With Inflammation of the Oral Mucosa Visit 3: 0=No inflammation	29 Particpants	33 Particpants
Number of Participants With Inflammation of the Oral Mucosa Visit 3: 1=Mild inflammation	0 Particpants	0 Particpants
Number of Participants With Inflammation of the Oral Mucosa Visit 3: 2=Moderate inflammation	0 Particpants	0 Particpants
Number of Participants With Inflammation of the Oral Mucosa Visit 3: 3=Severe inflammation	0 Particpants	0 Particpants
Number of Participants With Inflammation of the Oral Mucosa Visit 3: Not evaluated	2 Particpants	1 Particpants

PRIMARY outcome

Timeframe: Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment

Population: Safety Population, which consisted of all participants who received at least 1 dose of PEG 3350 or placebo and had at least 1 postdose safety assessment.

Participants underwent endoscopic examination of the esophageal mucosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).

Outcome measures

Outcome measures
Measure	PEG 3350 n=31 Participants Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.	Placebo n=34 Participants Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
Number of Participants With Inflammation of the Esophageal Mucosa Visit 3: Not evaluated	2 Participants	1 Participants
Number of Participants With Inflammation of the Esophageal Mucosa Visit 2: 0=No inflammation	31 Participants	34 Participants
Number of Participants With Inflammation of the Esophageal Mucosa Visit 2: 1=Mild inflammation	0 Participants	0 Participants
Number of Participants With Inflammation of the Esophageal Mucosa Visit 2: 2=Moderate inflammation	0 Participants	0 Participants
Number of Participants With Inflammation of the Esophageal Mucosa Visit 2: 3=Severe inflammation	0 Participants	0 Participants
Number of Participants With Inflammation of the Esophageal Mucosa Visit 2: Not evaluated	0 Participants	0 Participants
Number of Participants With Inflammation of the Esophageal Mucosa Visit 3: 0=No inflammation	26 Participants	29 Participants
Number of Participants With Inflammation of the Esophageal Mucosa Visit 3: 1=Mild inflammation	2 Participants	1 Participants
Number of Participants With Inflammation of the Esophageal Mucosa Visit 3: 2=Moderate inflammation	1 Participants	3 Participants
Number of Participants With Inflammation of the Esophageal Mucosa Visit 3: 3=Severe inflammation	0 Participants	0 Participants

Adverse Events

PEG 3350

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PEG 3350 n=31 participants at risk Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.	Placebo n=34 participants at risk Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
Gastrointestinal disorders Abdominal pain	12.9% 4/31 • Number of events 4 • Up to 44 days after start of treatment	17.6% 6/34 • Number of events 7 • Up to 44 days after start of treatment
Gastrointestinal disorders Abdominal discomfort	0.00% 0/31 • Up to 44 days after start of treatment	5.9% 2/34 • Number of events 2 • Up to 44 days after start of treatment
Gastrointestinal disorders Abdominal distension	0.00% 0/31 • Up to 44 days after start of treatment	8.8% 3/34 • Number of events 3 • Up to 44 days after start of treatment
Gastrointestinal disorders Diarrhoea	6.5% 2/31 • Number of events 2 • Up to 44 days after start of treatment	2.9% 1/34 • Number of events 1 • Up to 44 days after start of treatment
Gastrointestinal disorders Flatulence	3.2% 1/31 • Number of events 1 • Up to 44 days after start of treatment	11.8% 4/34 • Number of events 4 • Up to 44 days after start of treatment
Gastrointestinal disorders Haemorrhoids	6.5% 2/31 • Number of events 2 • Up to 44 days after start of treatment	0.00% 0/34 • Up to 44 days after start of treatment
Gastrointestinal disorders Nausea	12.9% 4/31 • Number of events 4 • Up to 44 days after start of treatment	5.9% 2/34 • Number of events 2 • Up to 44 days after start of treatment
Metabolism and nutrition disorders Decreased appetite	3.2% 1/31 • Number of events 1 • Up to 44 days after start of treatment	5.9% 2/34 • Number of events 2 • Up to 44 days after start of treatment
Nervous system disorders Dizziness	6.5% 2/31 • Number of events 2 • Up to 44 days after start of treatment	5.9% 2/34 • Number of events 3 • Up to 44 days after start of treatment
Nervous system disorders Headache	19.4% 6/31 • Number of events 8 • Up to 44 days after start of treatment	14.7% 5/34 • Number of events 6 • Up to 44 days after start of treatment

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharpe & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators have agreed to provide the Sponsor with the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication or presentation.
Publication restrictions are in place

Restriction type: OTHER