Trial Outcomes & Findings for SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation (NCT NCT01053962)
NCT ID: NCT01053962
Last Updated: 2020-01-02
Results Overview
Incidences of adverse events from Baseline through the end of the Follow-up period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)
Results posted on
2020-01-02
Participant Flow
This study was conducted between 3 March 2010 and 26 August 2010 at 14 study centers in the United States. Four dose cohorts were planned (0.3 mg, 1.0 mg, 3.0 mg, and 9.0 mg with 20 patients per dose cohort randomized in a 3:1 ratio \[15 pts receive SP-304, 5 pts receive placebo\].
During the pre-treatment period (Study Days -14 though -1), 84 eligible patients completed daily bowel movement diaries to obtain baseline data. Of these, 78 patients (58 and 20 patients for the SP-304 and placebo treatment groups, respectively) received at least one dose of study drug.
Participant milestones
| Measure |
SP-304 0.3 mg
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
SP-304 1.0 mg
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
SP-304 3.0 mg
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
SP-304 9.0 mg
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Placebo
Subjects receiving Placebo for 14 consecutive days
|
|---|---|---|---|---|---|
|
Pretreatment Period
STARTED
|
14
|
15
|
16
|
17
|
22
|
|
Pretreatment Period
COMPLETED
|
14
|
14
|
15
|
15
|
20
|
|
Pretreatment Period
NOT COMPLETED
|
0
|
1
|
1
|
2
|
2
|
|
Treatment Period
STARTED
|
14
|
14
|
15
|
15
|
20
|
|
Treatment Period
COMPLETED
|
13
|
14
|
15
|
15
|
17
|
|
Treatment Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
3
|
|
Follow-up Period
STARTED
|
13
|
14
|
15
|
15
|
17
|
|
Follow-up Period
COMPLETED
|
13
|
14
|
15
|
15
|
17
|
|
Follow-up Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
SP-304 0.3 mg
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
SP-304 1.0 mg
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
SP-304 3.0 mg
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
SP-304 9.0 mg
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Placebo
Subjects receiving Placebo for 14 consecutive days
|
|---|---|---|---|---|---|
|
Pretreatment Period
Withdrew Consent (Patient/PI)
|
0
|
0
|
0
|
1
|
2
|
|
Pretreatment Period
Venipuncture Failure
|
0
|
0
|
1
|
0
|
0
|
|
Pretreatment Period
Failed Urine drug screen Day 1
|
0
|
1
|
0
|
0
|
0
|
|
Pretreatment Period
Abnormal Lab values Exl 16
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Noncompliance with protocol
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
Baseline characteristics by cohort
| Measure |
SP-304 1.0 mg
n=14 Participants
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
SP-304 3.0 mg
n=15 Participants
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
SP-304 9.0 mg
n=15 Participants
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Placebo
n=20 Participants
Subjects receiving Placebo for 14 consecutive days
|
SP-304 0.3 mg
n=14 Participants
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
65 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 16.17 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 14.64 • n=4 Participants
|
51.1 years
STANDARD_DEVIATION 11.95 • n=21 Participants
|
48.9 years
STANDARD_DEVIATION 13.24 • n=10 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
69 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
20 participants
n=4 Participants
|
14 participants
n=21 Participants
|
78 participants
n=10 Participants
|
|
Complete Spontaneous Bowel Movement Frequency
|
0.6 CSBMs per week
STANDARD_DEVIATION 0.74 • n=5 Participants
|
0.5 CSBMs per week
STANDARD_DEVIATION 0.92 • n=7 Participants
|
0.4 CSBMs per week
STANDARD_DEVIATION 0.54 • n=5 Participants
|
0.3 CSBMs per week
STANDARD_DEVIATION 0.53 • n=4 Participants
|
0.4 CSBMs per week
STANDARD_DEVIATION 0.53 • n=21 Participants
|
0.4 CSBMs per week
STANDARD_DEVIATION 0.66 • n=10 Participants
|
|
Spontaneous Bowel Movement Frequency
|
2.2 events per week
STANDARD_DEVIATION 0.99 • n=5 Participants
|
2.1 events per week
STANDARD_DEVIATION 0.93 • n=7 Participants
|
1.9 events per week
STANDARD_DEVIATION 0.75 • n=5 Participants
|
2.0 events per week
STANDARD_DEVIATION 1.01 • n=4 Participants
|
2.2 events per week
STANDARD_DEVIATION 1.12 • n=21 Participants
|
2.1 events per week
STANDARD_DEVIATION 0.95 • n=10 Participants
|
|
Stool Consistency (Bristol Stool Form Scale)
|
2.6 units on a scale
STANDARD_DEVIATION 0.84 • n=5 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 0.69 • n=7 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 1.56 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 1.28 • n=4 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.81 • n=21 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.13 • n=10 Participants
|
|
Ease of Passage (Straining)
|
2.8 units on a scale
STANDARD_DEVIATION 0.79 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.61 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.89 • n=5 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.67 • n=4 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 0.64 • n=21 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 0.72 • n=10 Participants
|
PRIMARY outcome
Timeframe: 21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)Population: Safety Population: all patients who received at least one dose of the study medication.
Incidences of adverse events from Baseline through the end of the Follow-up period.
Outcome measures
| Measure |
SP-304 0.3 mg
n=14 Participants
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
SP-304 1.0 mg
n=14 Participants
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
SP-304 3.0 mg
n=15 Participants
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
SP-304 9.0 mg
n=15 Participants
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Placebo
n=20 Participants
Subjects receiving Placebo for 14 consecutive days
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Study days 1 through 14Population: Modified-Intent-to-Treat population: All patients who received at least one dose of study medication and had at least one post-baseline diary assessment. One participant in the SP-304 0.3 mg group did not have information about complete evacuation post-baseline.
Using a Daily Diary, patients recorded the number of spontaneous bowel movements having the sensation of complete evacuation (Complete Spontaneous Bowel Movement - CSBM). The total number of spontaneous bowel movements associated with a feeling of complete evacuation were summed and divided by 2 (the number of weeks in treatment). Change was calculated as the difference between the number of the CSBMs at the completion of the 2-week treatment period, versus the 14-day pretreatment baseline.
Outcome measures
| Measure |
SP-304 0.3 mg
n=13 Participants
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
SP-304 1.0 mg
n=14 Participants
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
SP-304 3.0 mg
n=15 Participants
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
SP-304 9.0 mg
n=15 Participants
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Placebo
n=20 Participants
Subjects receiving Placebo for 14 consecutive days
|
|---|---|---|---|---|---|
|
Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)
|
1.7 CSBMs per week
Standard Deviation 2.30
|
3.3 CSBMs per week
Standard Deviation 2.85
|
1.8 CSBMs per week
Standard Deviation 3.75
|
2.7 CSBMs per week
Standard Deviation 2.89
|
2.0 CSBMs per week
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Study Days 1 through 14Population: Modified-Intent-to-Treat population: All patients who received at least one dose of study medication and had at least one post-baseline diary assessment.
Using a Daily Diary, patients recorded the number of spontaneous bowel movements (SBM). The overall weekly frequency was calculated as the total number of SBMs divided by 2 (the number weeks of treatment). Change was calculated as the difference between the number of the SBMs at the completion of the 2-week treatment period, versus the 14-day pretreatment baseline.
Outcome measures
| Measure |
SP-304 0.3 mg
n=14 Participants
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
SP-304 1.0 mg
n=14 Participants
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
SP-304 3.0 mg
n=15 Participants
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
SP-304 9.0 mg
n=15 Participants
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Placebo
n=20 Participants
Subjects receiving Placebo for 14 consecutive days
|
|---|---|---|---|---|---|
|
Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)
|
2.4 SBMs per week
Standard Deviation 2.21
|
4.1 SBMs per week
Standard Deviation 4.1
|
2.4 SBMs per week
Standard Deviation 3.39
|
4.2 SBMs per week
Standard Deviation 2.88
|
2.4 SBMs per week
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: Study day 1 through 14Population: Modified-Intent-to-Treat population: All patients who received at least one dose of study medication and had at least one post-baseline diary assessment. One participant in the SP-304 0.3 mg group did not have post-baseline results.
Using a Daily Diary, patients recorded Stool Consistency using the 7-point Bristol Stool Form Scale (BSFS) (1 = separate hard lumps, like nuts; 2 sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges; 6 = fluffy pieces with ragged edges, a mushy stool; 7 = watery, no solid pieces, entirely liquid). Changes in mean BSFS were assessed from the average 14-day pretreatment baseline to the average during the 2-week treatment period.
Outcome measures
| Measure |
SP-304 0.3 mg
n=13 Participants
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
SP-304 1.0 mg
n=14 Participants
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
SP-304 3.0 mg
n=15 Participants
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
SP-304 9.0 mg
n=15 Participants
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Placebo
n=20 Participants
Subjects receiving Placebo for 14 consecutive days
|
|---|---|---|---|---|---|
|
Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)
|
1.1 units on a scale
Standard Deviation 1.23
|
1.8 units on a scale
Standard Deviation 1.18
|
1.6 units on a scale
Standard Deviation 1.53
|
1.8 units on a scale
Standard Deviation 1.56
|
0.9 units on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Study Days 1 through 14Population: Modified-Intent-to-Treat population: All patients who received at least one dose of study medication and had at least one post-baseline diary assessment. One participant in the SP-304 0.3 mg group did not have post-baseline results.
Using a Daily Diary, patients recorded Ease of Passage (Straining) using the 7-point Ease-of-Passage Scale (1 = manual disimpaction/enema needed, 2 = severe straining, 3 = moderate straining, 4 = mild straining, 5 = no straining, 6 = urgency, 7 = incontinent). Changes in overall ease of passage (Straining) were assessed from the average 14-day pretreatment baseline to average during the 2-week treatment period
Outcome measures
| Measure |
SP-304 0.3 mg
n=13 Participants
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
SP-304 1.0 mg
n=14 Participants
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
SP-304 3.0 mg
n=15 Participants
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
SP-304 9.0 mg
n=15 Participants
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Placebo
n=20 Participants
Subjects receiving Placebo for 14 consecutive days
|
|---|---|---|---|---|---|
|
Changes From Baseline Overall in Ease of Passage (Straining)
|
0.9 units on a scale
Standard Deviation 1.05
|
1.6 units on a scale
Standard Deviation 1.04
|
1.3 units on a scale
Standard Deviation 1.17
|
1.2 units on a scale
Standard Deviation 1.06
|
0.5 units on a scale
Standard Deviation 1.12
|
Adverse Events
SP-304 0.3 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SP-304 1.0 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SP-304 3.0 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SP-304 9.0 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SP-304 0.3 mg
n=14 participants at risk
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
SP-304 1.0 mg
n=14 participants at risk
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
SP-304 3.0 mg
n=15 participants at risk
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
SP-304 9.0 mg
n=15 participants at risk
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Placebo
n=20 participants at risk
Subjects receiving Placebo for 14 consecutive days
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • Number of events 1 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
Other adverse events
| Measure |
SP-304 0.3 mg
n=14 participants at risk
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
SP-304 1.0 mg
n=14 participants at risk
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
SP-304 3.0 mg
n=15 participants at risk
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
SP-304 9.0 mg
n=15 participants at risk
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Placebo
n=20 participants at risk
Subjects receiving Placebo for 14 consecutive days
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
13.3%
2/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
6.7%
1/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Hiatus Hernia
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Tingling Feeling in Mouth
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
6.7%
1/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Upset Stomach
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
6.7%
1/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
General disorders
Tiredness
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
6.7%
1/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Investigations
Elevated Amylase
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Investigations
Elevated Lipase
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
14.3%
2/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
6.7%
1/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
6.7%
1/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Investigations
Weight Loss
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
6.7%
1/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Musculoskeletal and connective tissue disorders
Intermittent Right Hand Pain
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
6.7%
1/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Musculoskeletal and connective tissue disorders
One Episode of Neck Muscle Spasm Left Side
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
6.7%
1/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Nervous system disorders
Head Pressure
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Nervous system disorders
Intermittent Headache
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Vascular disorders
Dizziness
|
7.1%
1/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Abdominal Cramping
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Excessive Flatulence
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
General disorders
Malaise
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Immune system disorders
Rhinitis (Due To Pollen)
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Injury, poisoning and procedural complications
Low Back Strain
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/14 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
0.00%
0/15 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
5.0%
1/20 • 21 Days
Baseline through 14 consecutive days of treatment plus 7 post-treatment days
|
Additional Information
Dr. Laura Barrow/Senior Vice President Clinical Development
Synergy Pharmaceuticals Inc
Phone: 212-297-0020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the results, either in part or in total (e.g., articles in journals or newspapers, oral presentations, abstracts) by the Investigator(s) or their representative(s), shall require prior notification, review, within a reasonable time frame, and written approval by the Sponsor. Additionally such publications cannot be made in violation of the Sponsor's confidentiality restrictions or to the detriment of the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER