Trial Outcomes & Findings for Study Comparing PEG 3350 Laxative to Placebo in the Treatment of Occasional Constipation (Study CL2007-12)(P08216) (NCT NCT00770432)
NCT ID: NCT00770432
Last Updated: 2018-10-02
Results Overview
A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
203 participants
Primary outcome timeframe
24 hours to 3 days after last dose of seven day treatment period.
Results posted on
2018-10-02
Participant Flow
Participant milestones
| Measure |
Polyethylene Glycol 3350 Powder for Solution
MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
|
Placebo
MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
101
|
|
Overall Study
COMPLETED
|
98
|
94
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Polyethylene Glycol 3350 Powder for Solution
MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
|
Placebo
MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
|
|---|---|---|
|
Overall Study
Other
|
4
|
6
|
|
Overall Study
Non-compliance
|
0
|
1
|
Baseline Characteristics
Study Comparing PEG 3350 Laxative to Placebo in the Treatment of Occasional Constipation (Study CL2007-12)(P08216)
Baseline characteristics by cohort
| Measure |
Polyethylene Glycol 3350 Powder for Solution
n=102 Participants
MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
|
Placebo
n=101 Participants
MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 12.52 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 14.15 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours to 3 days after last dose of seven day treatment period.Population: Per-Protocol Population
A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Powder for Solution
n=98 Participants
MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
|
Placebo
n=94 Participants
MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
|
|---|---|---|
|
Number of Participants With a Complete Resolution at the Final Visit
|
36 Participants
|
23 Participants
|
Adverse Events
Polyethylene Glycol 3350 Powder for Solution
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Polyethylene Glycol 3350 Powder for Solution
n=102 participants at risk
MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
|
Placebo
n=101 participants at risk
MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.8%
11/102 • Number of events 14
|
10.9%
11/101 • Number of events 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER