CIC: SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01053962
• Collaborator: (none)
• Enrollment: 84
• Locations: 14
• Arms: 5
• Duration (Months): 5
• Patients Per Site: 6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation.

Condition or Disease	Intervention/Treatment	Phase
Chronic Idiopathic Constipation	Drug: SP-304 0.3 mg; Drug: SP-304 1.0 mg; Drug: SP-304 3.0 mg; Drug: SP-304 9.0 mg; Drug: Placebo	Phase 2

Detailed Description

This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, PK and PD effects of SP-304 in patients with chronic idiopathic constipation. Patients diagnosed with chronic idiopathic constipation (CIC) will be screened for the anticipated 4 cohorts, to yield 80 randomized patients for enrollment. Four dose cohorts are planned (0.3 mg, 1.0 mg, 3.0mg, and 9.0 mg) with 20 patients per dose cohort [randomization ratio 3:1 (15 receive SP-304:5 receive placebo)]. Patients who continue to meet all the entry criteria and complete the pre-treatment bowel movement (BM) diary will receive, in a double-blind, randomized fashion, SP-304 or matching placebo. It is expected that each patient will complete all 14 days of dosing (including making accurate BM diary entries for all 14 days in the treatment period). All patients receiving at least one dose of SP-304 or matching placebo will be considered evaluable for the safety endpoints. If a patient receives at least 5 doses per treatment week (1 dose per day for 7 days) and has completed BM diary entries for those 5 dosing days in each corresponding treatment week, he/she will be considered evaluable.

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 14-Day Repeat, Oral, Dose Ranging Study to Assess the Safety, Pharmacokinetic and Pharmacodynamic Effects of SP-304 in Patients With Chronic Idiopathic Constipation
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SP-304 0.3 mg SP-304 0.3 mg tablet by mouth once daily for 14 consecutive days.	Drug: SP-304 0.3 mg; SP-304 0.3 mg
Experimental: SP-304 1.0 mg SP-304 1.0 mg tablet by mouth once daily for 14 consecutive days.	Drug: SP-304 1.0 mg; SP-304 1.0 mg
Experimental: SP-304 3.0 mg SP-304 3.0 mg tablet by mouth once daily for 14 consecutive days	Drug: SP-304 3.0 mg; SP-304 3.0 mg
Experimental: SP-304 9.0 mg SP-304 9.0 mg tablet by mouth once daily for 14 consecutive days.	Drug: SP-304 9.0 mg; SP-304 9.0 mg
Placebo Comparator: Placebo Placebo tablet by mouth once daily for 14 consecutive days	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)]

   Incidences of adverse events from Baseline through the end of the Follow-up period.

Secondary Outcome Measures

1. Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM) [Study days 1 through 14]

   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.

2. Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM) [Study Days 1 through 14]

   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.

3. Changes From Baseline Overall in Bristol Stool Form Scale (BSFS) [Study day 1 through 14]

   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.

4. Changes From Baseline Overall in Ease of Passage (Straining) [Study Days 1 through 14]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act [HIPAA]).

• Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.

• Subject has a body mass index (BMI) between 18 and 35 kg/m2.

• Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.

Exclusion Criteria:

• Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.

• Subjects who meet the Rome III criteria for IBS.

• Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novara Clinical Research	Mesa	Arizona	United States	85206
2	Genova Clinical Research	Tucson	Arizona	United States	85741
3	Advanced Clinical Research	Anaheim	California	United States	92801
4	Advanced Clinical Research	Orange	California	United States	92869
5	A.G.A. Clinical Trials	Hialeah	Florida	United States	33012
6	Miami Ressearch and Associates	Miami	Florida	United States	33143
7	Lee Research Institute	Shawnee Mission	Kansas	United States	66218
8	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan	United States	48047
9	Universtiy of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
10	Wake Research Associates	Raleigh	North Carolina	United States	27612
11	Memphis Gastroenterology Group	Germantown	Tennessee	United States	38138
12	Nashville Medical Research Institute	Nashville	Tennessee	United States	37205
13	DCOL Center for Clinical Research	Longview	Texas	United States	75605
14	Pioneer Research Solutions	Sugar Land	Texas	United States	77479

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Gary S Jacob, Ph.D., Synergy Pharmaceuticals Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT01053962
• Other Study ID Numbers: SP-SP304201-09
• First Posted: Jan 22, 2010
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Keywords provided by Bausch Health Americas, Inc.: Chronic Idiopathic Constipation; Constipation; Irritable Bowel Syndrome
• Additional relevant MeSH terms: Constipation; Plecanatide

Study Results

Participant Flow

Recruitment Details	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].
Pre-assignment Detail	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.

Arm/Group Title	SP-304 0.3 mg	SP-304 1.0 mg	SP-304 3.0 mg	SP-304 9.0 mg	Placebo
Arm/Group Description	Subjects receiving SP-304 0.3 mg for 14 consecutive days.	Subjects receiving SP-304 1.0 mg for 14 consecutive days	Subjects receiving SP-304 3.0 mg for 14 consecutive days	Subjects receiving SP-304 9.0 mg for 14 consecutive days	Subjects receiving Placebo for 14 consecutive days
Period Title: Pretreatment Period
STARTED	14	15	16	17	22
COMPLETED	14	14	15	15	20
NOT COMPLETED	0	1	1	2	2
Period Title: Pretreatment Period
STARTED	14	14	15	15	20
COMPLETED	13	14	15	15	17
NOT COMPLETED	1	0	0	0	3
Period Title: Pretreatment Period
STARTED	13	14	15	15	17
COMPLETED	13	14	15	15	17
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	SP-304 1.0 mg	SP-304 3.0 mg	SP-304 9.0 mg	Placebo	SP-304 0.3 mg	Total
Arm/Group Description	Subjects receiving SP-304 1.0 mg for 14 consecutive days	Subjects receiving SP-304 3.0 mg for 14 consecutive days	Subjects receiving SP-304 9.0 mg for 14 consecutive days	Subjects receiving Placebo for 14 consecutive days	Subjects receiving SP-304 0.3 mg for 14 consecutive days.	Total of all reporting groups
Overall Participants	14	15	15	20	14	78
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	12 85.7%	11 73.3%	14 93.3%	17 85%	11 78.6%	65 83.3%
>=65 years	2 14.3%	4 26.7%	1 6.7%	3 15%	3 21.4%	13 16.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.5 (10.6)	48.5 (16.17)	47.3 (12.71)	47.7 (14.64)	51.1 (11.95)	48.9 (13.24)
Sex: Female, Male (Count of Participants)
Female	14 100%	13 86.7%	12 80%	18 90%	12 85.7%	69 88.5%
Male	0 0%	2 13.3%	3 20%	2 10%	2 14.3%	9 11.5%
Region of Enrollment (participants) [Number]
United States	14 100%	15 100%	15 100%	20 100%	14 100%	78 100%
Complete Spontaneous Bowel Movement Frequency (CSBMs per week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [CSBMs per week]	0.6 (0.74)	0.5 (0.92)	0.4 (0.54)	0.3 (0.53)	0.4 (0.53)	0.4 (0.66)
Spontaneous Bowel Movement Frequency (events per week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [events per week]	2.2 (0.99)	2.1 (0.93)	1.9 (0.75)	2.0 (1.01)	2.2 (1.12)	2.1 (0.95)
Stool Consistency (Bristol Stool Form Scale) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.6 (0.84)	1.8 (0.69)	2.7 (1.56)	2.6 (1.28)	2.5 (0.81)	2.4 (1.13)
Ease of Passage (Straining) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.8 (0.79)	2.7 (0.61)	3.0 (0.89)	3.0 (0.67)	3.1 (0.64)	2.9 (0.72)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	Incidences of adverse events from Baseline through the end of the Follow-up period.
Time Frame	21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)

Outcome Measure Data

Analysis Population Description

Safety Population: all patients who received at least one dose of the study medication.

Arm/Group Title	SP-304 0.3 mg	SP-304 1.0 mg	SP-304 3.0 mg	SP-304 9.0 mg	Placebo
Arm/Group Description	Subjects receiving SP-304 0.3 mg for 14 consecutive days.	Subjects receiving SP-304 1.0 mg for 14 consecutive days	Subjects receiving SP-304 3.0 mg for 14 consecutive days	Subjects receiving SP-304 9.0 mg for 14 consecutive days	Subjects receiving Placebo for 14 consecutive days
Measure Participants	14	14	15	15	20
Count of Participants [Participants]	3 21.4%	6 40%	2 13.3%	6 30%	4 28.6%

2. Secondary Outcome

Title	Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)
Description	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.
Time Frame	Study days 1 through 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SP-304 0.3 mg	SP-304 1.0 mg	SP-304 3.0 mg	SP-304 9.0 mg	Placebo
Arm/Group Description	Subjects receiving SP-304 0.3 mg for 14 consecutive days. SP-304 0.3 mg: Subjects receiving SP-304 0.3 mg for 14 consecutive	Subjects receiving SP-304 1.0 mg for 14 consecutive days SP-304: Subjects receiving SP-304 1.0 mg for 14 consecutive days	Subjects receiving SP-304 3.0 mg for 14 consecutive days SP-304: Subjects receiving SP-304 3.0 mg for 14 consecutive days	Subjects receiving SP-304 9.0 mg for 14 consecutive days SP-304: Subjects receiving SP-304 9.0 mg for 14 consecutive days	Subjects receiving Placebo for 14 consecutive days Placebo: Subjects receiving Placebo for 14 consecutive days
Measure Participants	13	14	15	15	20
Mean (Standard Deviation) [CSBMs per week]	1.7 (2.30)	3.3 (2.85)	1.8 (3.75)	2.7 (2.89)	2.0 (3.02)

3. Secondary Outcome

Title	Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)
Description	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.
Time Frame	Study Days 1 through 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SP-304 0.3 mg	SP-304 1.0 mg	SP-304 3.0 mg	SP-304 9.0 mg	Placebo
Arm/Group Description	Subjects receiving SP-304 0.3 mg for 14 consecutive days.	Subjects receiving SP-304 1.0 mg for 14 consecutive days	Subjects receiving SP-304 3.0 mg for 14 consecutive days	Subjects receiving SP-304 9.0 mg for 14 consecutive days	Subjects receiving Placebo for 14 consecutive days
Measure Participants	14	14	15	15	20
Mean (Standard Deviation) [SBMs per week]	2.4 (2.21)	4.1 (4.1)	2.4 (3.39)	4.2 (2.88)	2.4 (2.67)

4. Secondary Outcome

Title	Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)
Description	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.
Time Frame	Study day 1 through 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SP-304 0.3 mg	SP-304 1.0 mg	SP-304 3.0 mg	SP-304 9.0 mg	Placebo
Arm/Group Description	Subjects receiving SP-304 0.3 mg for 14 consecutive days.	Subjects receiving SP-304 1.0 mg for 14 consecutive days	Subjects receiving SP-304 3.0 mg for 14 consecutive days	Subjects receiving SP-304 9.0 mg for 14 consecutive days	Subjects receiving Placebo for 14 consecutive days
Measure Participants	13	14	15	15	20
Mean (Standard Deviation) [units on a scale]	1.1 (1.23)	1.8 (1.18)	1.6 (1.53)	1.8 (1.56)	0.9 (1.23)

5. Secondary Outcome

Title	Changes From Baseline Overall in Ease of Passage (Straining)
Description	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
Time Frame	Study Days 1 through 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SP-304 0.3 mg	SP-304 1.0 mg	SP-304 3.0 mg	SP-304 9.0 mg	Placebo
Arm/Group Description	Subjects receiving SP-304 0.3 mg for 14 consecutive days.	Subjects receiving SP-304 1.0 mg for 14 consecutive days	Subjects receiving SP-304 3.0 mg for 14 consecutive days	Subjects receiving SP-304 9.0 mg for 14 consecutive days	Subjects receiving Placebo for 14 consecutive days
Measure Participants	13	14	15	15	20
Mean (Standard Deviation) [units on a scale]	0.9 (1.05)	1.6 (1.04)	1.3 (1.17)	1.2 (1.06)	0.5 (1.12)

Adverse Events

Time Frame	21 Days
Adverse Event Reporting Description	Baseline through 14 consecutive days of treatment plus 7 post-treatment days
Arm/Group Title	SP-304 0.3 mg		SP-304 1.0 mg		SP-304 3.0 mg		SP-304 9.0 mg		Placebo
Arm/Group Description	Subjects receiving SP-304 0.3 mg for 14 consecutive days.		Subjects receiving SP-304 1.0 mg for 14 consecutive days		Subjects receiving SP-304 3.0 mg for 14 consecutive days		Subjects receiving SP-304 9.0 mg for 14 consecutive days		Subjects receiving Placebo for 14 consecutive days
All Cause Mortality
	SP-304 0.3 mg		SP-304 1.0 mg		SP-304 3.0 mg		SP-304 9.0 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	SP-304 0.3 mg		SP-304 1.0 mg		SP-304 3.0 mg		SP-304 9.0 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
Renal and urinary disorders
Pyelonephritis	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	SP-304 0.3 mg		SP-304 1.0 mg		SP-304 3.0 mg		SP-304 9.0 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/14 (21.4%)		6/14 (42.9%)		2/15 (13.3%)		6/15 (40%)		4/20 (20%)
Endocrine disorders
Hyperglycemia	0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/15 (0%)		0/20 (0%)
Gastrointestinal disorders
Bloating	0/14 (0%)		0/14 (0%)		0/15 (0%)		1/15 (6.7%)		0/20 (0%)
Gastritis	1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		0/20 (0%)
Hiatus Hernia	1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		0/20 (0%)
Nausea	1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		0/20 (0%)
Tingling Feeling in Mouth	0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/15 (0%)		0/20 (0%)
Upset Stomach	0/14 (0%)		0/14 (0%)		0/15 (0%)		1/15 (6.7%)		0/20 (0%)
Abdominal Cramping	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
Abdominal Pain	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
Diarrhea	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
Excessive Flatulence	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
Flatulence	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
General disorders
Tiredness	0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/15 (0%)		0/20 (0%)
Malaise	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
Immune system disorders
Rhinitis (Due To Pollen)	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
Infections and infestations
Bronchitis	0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/15 (0%)		0/20 (0%)
Urinary Tract Infection	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
Injury, poisoning and procedural complications
Low Back Strain	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
Investigations
Elevated Amylase	1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		0/20 (0%)
Elevated Lipase	0/14 (0%)		2/14 (14.3%)		1/15 (6.7%)		1/15 (6.7%)		0/20 (0%)
Weight Loss	0/14 (0%)		0/14 (0%)		0/15 (0%)		1/15 (6.7%)		0/20 (0%)
Musculoskeletal and connective tissue disorders
Back Pain	0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/15 (0%)		0/20 (0%)
Intermittent Right Hand Pain	0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/15 (0%)		0/20 (0%)
Neck Pain	0/14 (0%)		0/14 (0%)		0/15 (0%)		1/15 (6.7%)		0/20 (0%)
One Episode of Neck Muscle Spasm Left Side	0/14 (0%)		0/14 (0%)		0/15 (0%)		1/15 (6.7%)		0/20 (0%)
Nervous system disorders
Headache	1/14 (7.1%)		0/14 (0%)		0/15 (0%)		2/15 (13.3%)		0/20 (0%)
Head Pressure	1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		0/20 (0%)
Intermittent Headache	0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/15 (0%)		0/20 (0%)
Renal and urinary disorders
Hydronephrosis	0/14 (0%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		1/20 (5%)
Vascular disorders
Dizziness	1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/15 (0%)		0/20 (0%)

Limitations/Caveats

This Phase 2a study was not sized to evaluate efficacy.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.