Trial Outcomes & Findings for A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome (NCT NCT00977197)
NCT ID: NCT00977197
Last Updated: 2016-10-28
Results Overview
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
COMPLETED
PHASE2
85 participants
weeks 9-12
2016-10-28
Participant Flow
Participant milestones
| Measure |
Pregabalin
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
Pregabalin: Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
Subjects randomized to this arm will receive placebo matching the study drug.
Placebo: A matching placebo will be administered twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
44
|
|
Overall Study
COMPLETED
|
32
|
35
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
Pregabalin
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
Pregabalin: Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
Subjects randomized to this arm will receive placebo matching the study drug.
Placebo: A matching placebo will be administered twice a day
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Nonadherence
|
1
|
1
|
Baseline Characteristics
A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
Baseline characteristics by cohort
| Measure |
Pregabalin
n=41 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=44 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
44 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Number of Subjects with Fibromyalgia at Baseline
Fibromyalgia - No
|
31 participants
n=5 Participants
|
37 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Number of Subjects with Fibromyalgia at Baseline
Fibromyalgia - Yes
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weeks 9-12Population: Intent to treat analysis
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=41 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=44 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)
|
25.3 units on a scale
Standard Deviation 16.0
|
42.0 units on a scale
Standard Deviation 26.6
|
SECONDARY outcome
Timeframe: weeks 9-12Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=29 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=35 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)
|
26.5 units on a scale
Standard Deviation 15.2
|
42.2 units on a scale
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: Weeks 9-12Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=29 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=35 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)
|
25.8 units on a scale
Standard Deviation 26.8
|
22.4 units on a scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: Weeks 9-12Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=29 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=35 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
|
16.9 units on a scale
Standard Deviation 18.4
|
31.8 units on a scale
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: Weeks 9-12)Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=29 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=35 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
|
29.3 units on a scale
Standard Deviation 23.3
|
43.6 units on a scale
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: Weeks 9-12Population: Intent to treat analysis
One of the weekly questions asked of subjects was, "Did you have adequate relief of your IBS symptoms over the last week?" Possible answers were Yes or No.
Outcome measures
| Measure |
Pregabalin
n=41 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=44 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy
Adequate Relief (Yes)
|
19 participants
|
16 participants
|
|
Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy
Inadequate Relief (No)
|
22 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=29 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=34 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Mean Pain BSS Score at Week 12
|
26.1 units on a scale
Standard Deviation 18.8
|
43.3 units on a scale
Standard Deviation 30
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=29 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=34 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Mean Overall Severity BSS Score at Week 12
|
28.5 units on a scale
Standard Deviation 20.2
|
44.2 units on a scale
Standard Deviation 28.8
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=29 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=34 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Mean Constipation BSS Score at Week 12
|
26.1 units on a scale
Standard Deviation 30.4
|
23.6 units on a scale
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=29 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=34 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Mean Diarrhea BSS Score at Week 12
|
15.6 units on a scale
Standard Deviation 19.8
|
34.4 units on a scale
Standard Deviation 29.7
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=29 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=34 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Mean Bloating BSS Score at Week 12
|
26.3 units on a scale
Standard Deviation 24.4
|
45.0 units on a scale
Standard Deviation 32.0
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Intent to Treat analysis
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Outcome measures
| Measure |
Pregabalin
n=41 Participants
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=44 Participants
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score
Yes, >= 30 point change
|
26 participants
|
20 participants
|
|
Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score
No, >= 30 point change
|
15 participants
|
24 participants
|
Adverse Events
Pregabalin
Placebo
Serious adverse events
| Measure |
Pregabalin
n=41 participants at risk
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=44 participants at risk
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
Social circumstances
External Trauma
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
Other adverse events
| Measure |
Pregabalin
n=41 participants at risk
Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
|
Placebo
n=44 participants at risk
Subjects randomized to this arm will receive placebo matching the study drug.
|
|---|---|---|
|
General disorders
Insomnia
|
2.4%
1/41 • Number of events 1 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
14.6%
6/41 • Number of events 7 • 1 year
|
15.9%
7/44 • Number of events 11 • 1 year
|
|
General disorders
Tired
|
14.6%
6/41 • Number of events 9 • 1 year
|
11.4%
5/44 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in lower chest
|
9.8%
4/41 • Number of events 4 • 1 year
|
0.00%
0/44 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Cramping right side
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
2.4%
1/41 • Number of events 1 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
14.6%
6/41 • Number of events 6 • 1 year
|
11.4%
5/44 • Number of events 5 • 1 year
|
|
Nervous system disorders
Dizzy
|
31.7%
13/41 • Number of events 20 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
Eye disorders
Blurred Vision
|
14.6%
6/41 • Number of events 6 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
31.7%
13/41 • Number of events 15 • 1 year
|
29.5%
13/44 • Number of events 17 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
9.8%
4/41 • Number of events 4 • 1 year
|
11.4%
5/44 • Number of events 6 • 1 year
|
|
Nervous system disorders
Migraine
|
4.9%
2/41 • Number of events 2 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Upset stomach
|
9.8%
4/41 • Number of events 7 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Infections and infestations
Flu like symptoms
|
2.4%
1/41 • Number of events 1 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Cardiac disorders
Heart racing
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
22.0%
9/41 • Number of events 11 • 1 year
|
9.1%
4/44 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Mucus in bowel movement
|
4.9%
2/41 • Number of events 4 • 1 year
|
0.00%
0/44 • 1 year
|
|
General disorders
Weight gain
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
General disorders
Restless at night
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.9%
2/41 • Number of events 2 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
14.6%
6/41 • Number of events 6 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
General disorders
Body aches
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
General disorders
Chills
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
Abdominal gas
|
9.8%
4/41 • Number of events 4 • 1 year
|
9.1%
4/44 • Number of events 5 • 1 year
|
|
General disorders
Stress
|
2.4%
1/41 • Number of events 1 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
Nervous system disorders
Feeling of being high or tipsy
|
9.8%
4/41 • Number of events 6 • 1 year
|
0.00%
0/44 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • Number of events 1 • 1 year
|
6.8%
3/44 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Paresthesia (tingling) of the fingers
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
Fullness in the abdomen
|
4.9%
2/41 • Number of events 2 • 1 year
|
0.00%
0/44 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
2/41 • Number of events 2 • 1 year
|
0.00%
0/44 • 1 year
|
|
Skin and subcutaneous tissue disorders
Itch
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
General disorders
Fever
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptoms
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
2.4%
1/41 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
Burping
|
2.4%
1/41 • Number of events 1 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Eye disorders
Dry eyes
|
2.4%
1/41 • Number of events 2 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
More bowel movements than usual
|
4.9%
2/41 • Number of events 2 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Loss of appetite
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
No libido
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in upper right chest
|
0.00%
0/41 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Excessive thirst
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Cardiac disorders
Blood pressure increased
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle pain rib cage right side
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
General disorders
Pain over all body
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain lower left side
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Fingers swelling
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Urgency to defecate
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Foot peripheral edema
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Gout in arches of feet
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Infections and infestations
Bladder infection
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
General disorders
Increased hunger
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching in upper back
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Change in appearance of stool
|
0.00%
0/41 • 1 year
|
6.8%
3/44 • Number of events 3 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
General disorders
Vivid dreams
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Nerve pain down arms and legs
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 2 • 1 year
|
|
General disorders
Loss of nails
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place