Trial Outcomes & Findings for The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome (NCT NCT02431533)

NCT ID: NCT02431533

Last Updated: 2020-06-12

Results Overview

For each patient stool frequency was measured as a number of bowel movements per day. To compare stool frequency before and after the treatment, the average for the first 2 run-in weeks (day 1 - day 14) and the last 2 weeks (day 78 - day 91) was calculated. A higher mean score indicates a better outcome, a greater reduction in bowel movements/day and is a positive change. Placebo group- min: -.43 max: 1.43 Study group- min: -.43 max: 1.50

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)
• Results posted on: 2020-06-12

Participant Flow

Participant milestones

Measure	Probiotic PX0612 PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Overall Study STARTED	25	25
Overall Study COMPLETED	23	22
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Probiotic PX0612 PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Overall Study Withdrawal by Subject	1	3
Overall Study Developed Exclusionary criteria	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Probiotic PX0612 n=25 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=25 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate	Total n=50 Participants Total of all reporting groups
Age, Customized >18 and <65 years of age	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
Sex: Female, Male Female	13 Participants n=25 Participants	14 Participants n=25 Participants	27 Participants n=50 Participants
Sex: Female, Male Male	12 Participants n=25 Participants	11 Participants n=25 Participants	23 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Bowel Movements Per Day	2.35 bowel movements/day n=25 Participants	2.39 bowel movements/day n=25 Participants	2.37 bowel movements/day n=50 Participants
Functional Bowel Disorder Severity Index	272 units on a scale n=25 Participants	234 units on a scale n=25 Participants	253 units on a scale n=50 Participants
Abdominal Pain- higher the number, greater the pain	1.34 units on a scale n=25 Participants	1.2 units on a scale n=25 Participants	1.27 units on a scale n=50 Participants
Stool Consistency	5.08 units on a scale n=25 Participants	4.73 units on a scale n=25 Participants	4.91 units on a scale n=50 Participants
Short Form 36 Health Survey	48.92 units on a scale STANDARD_DEVIATION 7.38 • n=25 Participants	50.49 units on a scale STANDARD_DEVIATION 7.44 • n=25 Participants	49.71 units on a scale STANDARD_DEVIATION 7.41 • n=50 Participants

PRIMARY outcome

Timeframe: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)

Population: The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.

For each patient stool frequency was measured as a number of bowel movements per day. To compare stool frequency before and after the treatment, the average for the first 2 run-in weeks (day 1 - day 14) and the last 2 weeks (day 78 - day 91) was calculated.

A higher mean score indicates a better outcome, a greater reduction in bowel movements/day and is a positive change.

Placebo group- min: -.43 max: 1.43

Study group- min: -.43 max: 1.50

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=21 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.	.46 bowel movements/day Interval 0.25 to 0.67	.21 bowel movements/day Interval -0.04 to 0.46

SECONDARY outcome

Timeframe: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)

Mean change in heartburn between baseline (days 1-14) and weeks 10 and 11 (days 78-91) between the two groups.

A higher mean value indicates a greater reduction in heartburn, better outcome.

Analog Scale from 0-4 was used by participants to rate upper GI symptoms of heartburn (0= no heartburn, 4= incapacitating).

Placebo group- Min: -2.00 Max: 3.00

Treatment group- Min: -2.00 Max: 2.00

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=22 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Differences in Upper Gastrointestinal Symptoms Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.	.09 units on a scale Interval -0.3 to 0.48	-.09 units on a scale Interval -0.48 to 0.29

SECONDARY outcome

Timeframe: Baseline compared to Week 12

vomit scale used was from 0-4, the higher the number, the worse the outcome Mean change in vomiting between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in vomiting, better outcome.

Analog Scale from 0-4 was used by participants to rate upper GI symptoms of vomiting(0= none, 4= incapacitating).

Placebo group- Min: 0 Max: 0

Treatment group- Min: -3.00 Max: 0

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=22 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Differences in Upper Gastrointestinal Symptoms- Vomiting Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.	-.22 units on a scale Interval -0.51 to 0.07	0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline compared to Week 12 (end of study)

Population: The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.

Differences in quality of life phusical component score using SF-36 between the 'intervention' group and the 'placebo' group over the study period. Baseline PCS scores were compared to the end of the study time point. The mean difference between the 2 time points was measured.

The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. Scoring is based on software program.

Placebo group- Min: -16.16 Max: 6.25

Treatment group- Min: -16.42 Max: 5.46

The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study.

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=21 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Changes in the Patient's Assessment of Their Quality of Life Using Short Form(SF)-36 Health Survey PCS (Physical Component Score)	-2.27 units on a scale Interval -4.35 to -0.19	-2.05 units on a scale Interval -4.53 to 0.43

SECONDARY outcome

Timeframe: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)

Population: The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.

Outcome measure is the mean change of abdominal pain, on a scale of 0-4 (0= no pain, 4= incapacitating pain), between baseline and Weeks 10 and 11. A larger change in average abdominal pain indicates a greater reduction in mean abdominal pain score, better outcome.

Min=-.067 for treatment group Min= -.99 for placebo group Max= 1.14 for treatment group Max= 1.63 for placebo group The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study.

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=21 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Differences in Abdominal Pain/Discomfort Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.	0.35 units on a scale Interval 0.13 to 0.56	0.44 units on a scale Interval 0.16 to 0.72

SECONDARY outcome

Timeframe: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)

Population: The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.

The stool consistency before and after the treatment was compared, the average for the first 2 run-in weeks (day 1 - day 14) and the last 2 weeks (day 78 - day 91) was calculated. A higher mean outcome indicates a greater reduction in loose stool/diarrhea (better outcome).

Bristol Stool Chart (1=severe constipation to 7 =severe diarrhea) was the scale used for measurement. The participant reported outcomes were averaged at above time points for comparison.

Min for placebo group: -.70 Max for treatment group: 2.57 Max for placebo group: 1.88

The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study.

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=21 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Differences in Stool Consistency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.	0.51 units on a scale Interval 0.16 to 0.86	0.46 units on a scale Interval 0.14 to 0.78

SECONDARY outcome

Timeframe: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)

Population: The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.

Number of stools/day

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=21 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Differences in Stool Frequency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.	2.35 stools/day Interval 1.96 to 2.73	2.39 stools/day Interval 1.87 to 2.73

SECONDARY outcome

Timeframe: Baseline compared to Week 12

Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Change in rate of early satiety on a scale from 0-4 (higher the score, the worse the outcome) Mean change in early satiety between baseline and week 12 between the two groups.

A higher mean value indicates a greater reduction in early satiety, better outcome.

Analog Scale from 0-4 was used by participants to rate upper GI symptoms of early satiety (0= none, 4= incapacitating).

Placebo group- Min: -2.00 Max: 1.00

Treatment group- Min: -2.00 Max: 2.00

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=22 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Differences in Upper Gastrointestinal Symptoms- Early Satiety	.26 units on a scale Interval -0.13 to 0.66	-.27 units on a scale Interval -0.66 to 0.12

SECONDARY outcome

Timeframe: Baseline compared to Week 12

Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in postprandial fullness between baseline and week 12 between the two groups.

A higher mean value indicates a greater reduction in a postprandial fullness, better outcome.

Analog Scale from 0-4 was used by participants to rate upper GI symptoms of postprandial fullness (0= no postprandial fullness, 4= incapacitating postprandial fullness).

Placebo group- Min: -1.00 Max: 2.00

Treatment group- Min: -1.00 Max: 2.00

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=22 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
The Difference in Change of Postprandial Fullness Severity	.22 units on a scale Interval -0.1 to 0.54	.18 units on a scale Interval -0.22 to 0.58

SECONDARY outcome

Timeframe: Baseline compared to Week 12

Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in prolonged digestion between baseline and week 12 between the two groups.

A higher mean value indicates a greater reduction in prolonged digestion, better outcome.

Analog Scale from 0-4 was used by participants to rate upper GI symptoms of prolonged digestion (0= none, 4= incapacitating).

Placebo group- Min: -2.00 Max: 1.00

Treatment group- Min: -1.00 Max: 3.00

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=22 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Upper Gastrointestinal Symptoms of Prolonged Digestion	.35 units on a scale Interval -0.03 to 0.73	-.05 units on a scale Interval -0.42 to 0.33

SECONDARY outcome

Timeframe: Baseline and Week 12

Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in nausea between baseline and week 12 between the two groups.

A higher mean value indicates a greater reduction in nausea, better outcome.

Analog Scale from 0-4 was used by participants to rate upper GI symptoms of nausea(0= none, 4= incapacitating).

Placebo group- Min: 0.00 Max: 2.00

Treatment group- Min: -1.00 Max: 1.00

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=22 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Upper Gastrointestinal Symptom of Nausea	.09 units on a scale Interval -0.2 to 0.38	.32 units on a scale Interval 0.03 to 0.6

SECONDARY outcome

Timeframe: Baseline compared to Week 12

Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in FBDSI score between baseline and week 12 between the two groups.

A higher mean value indicates a greater reduction in bowel disease severity, better outcome.

Functional Bowel Disease Severity Index was the scale used to determine this outcome. The range on this scale is from 0-500, with 500 indicating the most severe functional bowel disease.

Placebo group- Min: -10.00 Max: 350.00

Treatment group- Min: 0 Max: 300.00

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=22 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
FBDSI (Functional Bowel Disease Severity Index)	96.26 units on a scale Interval 66.04 to 126.48	133.41 units on a scale Interval 93.22 to 173.6

POST_HOC outcome

Timeframe: Baseline assessment compared to visit 5 assessment

Population: The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.

Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in FBDSI score between baseline and week 12 between the two groups.

A higher mean value indicates a greater reduction in bowel disease severity, better outcome.

Functional Bowel Disease Severity Index was the scale used to determine this outcome. The range on this scale is from 0-500, with 500 indicating the most severe functional bowel disease.

This measure represents the total number of participants that had a 30% or greater reduction in FBDSI score.

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=22 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Participants With 30% or More Reduction in Functional Bowel Disease Severity Index (FBDSI)	10 Participants	3 Participants

POST_HOC outcome

Timeframe: Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)

Population: The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.

Percentage of participants with a greater than 30% reduction in the number of stools/day.

Outcome measures

Measure	Probiotic PX0612 n=23 Participants PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=22 Participants Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Unplanned Analysis- Participants With 30% or Greater Reduction in Stool Frequency/Day	35 percentage of participants Interval 18.0 to 56.0	9 percentage of participants Interval 2.1 to 31.0

Adverse Events

Probiotic PX0612

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Di-Calcium Phosphate

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Probiotic PX0612 n=25 participants at risk PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule.	Di-Calcium Phosphate n=25 participants at risk Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Gastrointestinal disorders Heartburn	12.0% 3/25 • Number of events 3 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	4.0% 1/25 • Number of events 1 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
Gastrointestinal disorders increased bloating/gas	4.0% 1/25 • Number of events 3 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	8.0% 2/25 • Number of events 3 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
Skin and subcutaneous tissue disorders Hives	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	4.0% 1/25 • Number of events 1 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
Respiratory, thoracic and mediastinal disorders Upper respiratory symptoms	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	4.0% 1/25 • Number of events 1 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
Nervous system disorders Increased Restless Leg Syndrome	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	4.0% 1/25 • Number of events 1 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
General disorders Lower back pain	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	8.0% 2/25 • Number of events 2 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
General disorders Migraine/headache	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	4.0% 1/25 • Number of events 1 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
Endocrine disorders Thyroiditis	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	12.0% 3/25 • Number of events 3 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
Gastrointestinal disorders Vomiting	12.0% 3/25 • Number of events 3 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
General disorders Weight gain	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	4.0% 1/25 • Number of events 1 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
General disorders Ear pain/dizziness	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	4.0% 1/25 • Number of events 1 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
Psychiatric disorders Anxiety	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	4.0% 1/25 • Number of events 1 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards
General disorders Chest pain	0.00% 0/25 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards	4.0% 1/25 • Number of events 1 • Adverse events were collected during study participation over a 14 week period for each participant. Reporting was performed as per GCP standards

Additional Information

Mark Cobb

Pharmabiotix, Inc

Phone: 214-327-4712

Email: cobbcoinc@aol.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place