Trial Outcomes & Findings for Effects of Open-label vs Double-blind Treatment in IBS (NCT NCT02802241)
NCT ID: NCT02802241
Last Updated: 2024-01-22
Results Overview
Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
340 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-01-22
Participant Flow
Participant milestones
| Measure |
Open-label Placebo
placebo
|
Double-blind Placebo
placebo
|
Double-blind Peppermint Oil
peppermint oil
|
no Pill Control
control
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
89
|
87
|
46
|
86
|
|
Overall Study
Planned Analysis
|
89
|
87
|
46
|
86
|
|
Overall Study
COMPLETED
|
68
|
71
|
30
|
72
|
|
Overall Study
NOT COMPLETED
|
21
|
16
|
16
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Open-label vs Double-blind Treatment in IBS
Baseline characteristics by cohort
| Measure |
Open-label Placebo
n=89 Participants
placebo
|
Double-blind Placebo
n=87 Participants
placebo
|
no Pill Control
n=86 Participants
control
|
Double-blind Peppermint Oil
n=46 Participants
peppermint oil
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 17.6 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 19.2 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 17.7 • n=5 Participants
|
41.0 years
STANDARD_DEVIATION 17.4 • n=4 Participants
|
42.0 years
STANDARD_DEVIATION 18.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
224 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
255 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
IBS-SSS
|
286.0 units on a scale
STANDARD_DEVIATION 62 • n=5 Participants
|
285.8 units on a scale
STANDARD_DEVIATION 69.0 • n=7 Participants
|
274.4 units on a scale
STANDARD_DEVIATION 71.1 • n=5 Participants
|
283.5 units on a scale
STANDARD_DEVIATION 71.7 • n=4 Participants
|
282.1 units on a scale
STANDARD_DEVIATION 67.4 • n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Double-blind peppermint oil data was not part of the planned analysis. While the data was collected, the results were analyzed with a modified intention to treat which differs from the primary analysis of intention to treat. The outcome results data are not an accurate comparision.
Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms
Outcome measures
| Measure |
Open-label Placebo
n=89 Participants
placebo
|
Double-blind Placebo
n=87 Participants
placebo
|
no Pill Control
n=86 Participants
control
|
Double-blind Peppermint Oil
n=46 Participants
peppermint oil
|
|---|---|---|---|---|
|
Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
intention to treat
|
74.6 score on a scale
Interval 47.3 to 101.8
|
94.6 score on a scale
Interval 71.8 to 117.4
|
56.4 score on a scale
Interval 31.4 to 81.4
|
90.8 score on a scale
Interval 45.0 to 102.0
|
|
Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
planned analysis
|
90.6 score on a scale
Interval 68.6 to 112.6
|
100.3 score on a scale
Interval 78.7 to 121.8
|
52.3 score on a scale
Interval 30.8 to 73.7
|
90.8 score on a scale
Interval 75.3 to 110.0
|
Adverse Events
Open-label Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Double-blind Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Double-blind Peppermint Oil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
no Pill Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-label Placebo
n=96 participants at risk
placebo
|
Double-blind Placebo
n=97 participants at risk
placebo
|
Double-blind Peppermint Oil
peppermint oil
|
no Pill Control
n=98 participants at risk
control
|
|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
5.2%
5/96 • Number of events 5 • 6 weeks
Participants are not at risk for adverse events or mortality since they were not given an active medication. Double-blind peppermint oil data was not collected as part of this study.
|
5.2%
5/97 • Number of events 5 • 6 weeks
Participants are not at risk for adverse events or mortality since they were not given an active medication. Double-blind peppermint oil data was not collected as part of this study.
|
—
0/0 • 6 weeks
Participants are not at risk for adverse events or mortality since they were not given an active medication. Double-blind peppermint oil data was not collected as part of this study.
|
0.00%
0/98 • 6 weeks
Participants are not at risk for adverse events or mortality since they were not given an active medication. Double-blind peppermint oil data was not collected as part of this study.
|
|
Gastrointestinal disorders
heartburn
|
1.0%
1/96 • Number of events 1 • 6 weeks
Participants are not at risk for adverse events or mortality since they were not given an active medication. Double-blind peppermint oil data was not collected as part of this study.
|
6.2%
6/97 • Number of events 6 • 6 weeks
Participants are not at risk for adverse events or mortality since they were not given an active medication. Double-blind peppermint oil data was not collected as part of this study.
|
—
0/0 • 6 weeks
Participants are not at risk for adverse events or mortality since they were not given an active medication. Double-blind peppermint oil data was not collected as part of this study.
|
0.00%
0/98 • 6 weeks
Participants are not at risk for adverse events or mortality since they were not given an active medication. Double-blind peppermint oil data was not collected as part of this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place