An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

• Sponsor: Otsuka Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00463151
• Collaborator: (none)
• Enrollment: 124
• Locations: 5
• Arms: 4
• Duration (Months): 14
• Patients Per Site: 24.8
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative	Drug: rebamipide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 0mg rebamipide	Drug: rebamipide; 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
Experimental: 2 60mg rebamipide	Drug: rebamipide; 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
Experimental: 3 150mg rebamipide	Drug: rebamipide; 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
Experimental: 4 300mg rebamipide	Drug: rebamipide; 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon

Outcome Measures

Primary Outcome Measures

1. Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) [Week 6]

   Definition of clinical improvement: a decrease of Disease Activity Index [DAI] score for "rectal bleeding" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "findings on endoscopy" from the baseline

Secondary Outcome Measures

1. Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) [Week 6]

   Definition of remission: a decrease of the total DAI scores for "rectal bleeding" and "findings on endoscopy" to 0 points

2. Mean Change From Baseline in Total DAI Score [Baseline and Week 6]

   DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement.

3. Percentage of Subjects Showing Improvement in Each DAI Subscore [Baseline and week 6]

   DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change from baseline indicates improvement.

4. Mean Change From Baseline in Total Endoscopic Index (EI) Score [Baseline and Week 6]

   The index consisted of 4 subscales: granulation scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage. Each subscale was scored on a scale of 0 to 4 and the total score (the sum of all 4 subscores) ranges from 0 to 12, higher scores indicate more severe disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with active ulcerative colitis

2. Patients having an insufficient response to ASA oral formulation: (1) Patients whose ongoing use of ASA oral formulation from ≥2 weeks prior to the day before registration is fixed at mesalazine ≥2 g/day or salazosulfapyridine 3-6 g/day, (2) Patients with continuous bloody stools from ≥2 weeks prior to the day before registration, (3) Patients whose DAI subscores are ≥2 points for "bloody stools" and ≥2 points for "endoscopic findings"

3. Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure)

4. Outpatients

Exclusion Criteria:

1. Patients who have a history of intestinal resection (other than appendiceal resection)

2. Patients who have a complication of malignant tumor

3. Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period

4. Patients who have complications of serious cardiac, hepatic or renal impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Chubu Region		Japan
2		Chugoku Region		Japan
3		Hokkaido region		Japan
4		Kinki Region		Japan
5		Kyushu Region		Japan

Sponsors and Collaborators

• Otsuka Pharmaceutical Co., Ltd.

Investigators

• Study Director: Katsuhisa Saito, Division of New Product Evaluation and Development

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00463151
• Other Study ID Numbers: 037-06-001; JapicCTI-070399
• First Posted: Apr 20, 2007
• Last Update Posted: Jul 20, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by , ,: Rebamipide; Enema; Ulcerative Colitis
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Rebamipide

Study Results

Participant Flow

Arm/Group Title	Rebamipide 60 mg	Rebamipide 150 mg	Rebamipide 300 mg	Placebo
Arm/Group Description	Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Once daily intracolonial administration of placebo for 6 weeks
Period Title: Overall Study
STARTED	35	29	29	31
COMPLETED	33	24	26	24
NOT COMPLETED	2	5	3	7

Baseline Characteristics

Arm/Group Title	Rebamipide 60 mg	Rebamipide 150 mg	Rebamipide 300 mg	Placebo	Total
Arm/Group Description	Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Once daily intracolonial administration of placebo for 6 weeks	Total of all reporting groups
Overall Participants	35	29	27	30	121
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	34 97.1%	26 89.7%	25 92.6%	28 93.3%	113 93.4%
>=65 years	1 2.9%	3 10.3%	2 7.4%	2 6.7%	8 6.6%
Sex: Female, Male (Count of Participants)
Female	14 40%	16 55.2%	8 29.6%	14 46.7%	52 43%
Male	21 60%	13 44.8%	19 70.4%	16 53.3%	69 57%
Region of Enrollment (Count of Participants)
Japan	35 100%	29 100%	27 100%	30 100%	121 100%

Outcome Measures

1. Primary Outcome

Title	Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100)
Description	Definition of clinical improvement: a decrease of Disease Activity Index [DAI] score for "rectal bleeding" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "findings on endoscopy" from the baseline
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

Arm/Group Title	Rebamipide 60 mg	Rebamipide 150 mg	Rebamipide 300 mg	Placebo
Arm/Group Description	Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Once daily intracolonial administration of placebo for 6 weeks
Measure Participants	35	29	27	30
Number (95% Confidence Interval) [percentage of participants]	31.4 89.7%	24.1 83.1%	44.4 164.4%	30.0 100%

2. Secondary Outcome

Title	Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100)
Description	Definition of remission: a decrease of the total DAI scores for "rectal bleeding" and "findings on endoscopy" to 0 points
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

Arm/Group Title	Rebamipide 60 mg	Rebamipide 150 mg	Rebamipide 300 mg	Placebo
Arm/Group Description	Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Once daily intracolonial administration of placebo for 6 weeks
Measure Participants	35	29	27	30
Number (95% Confidence Interval) [percentage of participants]	2.9 8.3%	0.0 0%	18.5 68.5%	3.3 11%

3. Secondary Outcome

Title	Mean Change From Baseline in Total DAI Score
Description	DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement.
Time Frame	Baseline and Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

Arm/Group Title	Rebamipide 60 mg	Rebamipide 150 mg	Rebamipide 300 mg	Placebo
Arm/Group Description	Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Once daily intracolonial administration of placebo for 6 weeks
Measure Participants	33	26	26	27
Mean (Standard Deviation) [score on a scale]	-2.5 (2.5)	-1.6 (2.6)	-3.0 (3.0)	-2.0 (2.1)

4. Secondary Outcome

Title	Percentage of Subjects Showing Improvement in Each DAI Subscore
Description	DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change from baseline indicates improvement.
Time Frame	Baseline and week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

Arm/Group Title	Rebamipide 60 mg	Rebamipide 150 mg	Rebamipide 300 mg	Placebo
Arm/Group Description	Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Once daily intracolonial administration of placebo for 6 weeks
Measure Participants	35	29	27	30
Stool frequency	48.6 138.9%	31.0 106.9%	59.3 219.6%	10.0 33.3%
Rectal bleeding	65.7 187.7%	51.7 178.3%	66.7 247%	63.3 211%
Findings on endoscopy	39.4 112.6%	26.9 92.8%	53.8 199.3%	48.1 160.3%
Physician's global assessment	48.6 138.9%	31.0 106.9%	51.9 192.2%	36.70 122.3%

5. Secondary Outcome

Title	Mean Change From Baseline in Total Endoscopic Index (EI) Score
Description	The index consisted of 4 subscales: granulation scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage. Each subscale was scored on a scale of 0 to 4 and the total score (the sum of all 4 subscores) ranges from 0 to 12, higher scores indicate more severe disease.
Time Frame	Baseline and Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

Arm/Group Title	Rebamipide 60 mg	Rebamipide 150 mg	Rebamipide 300 mg	Placebo
Arm/Group Description	Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Once daily intracolonial administration of placebo for 6 weeks
Measure Participants	33	26	26	27
Mean (Standard Deviation) [score on a scale]	-1.6 (2.2)	-1.2 (2.5)	-2.4 (2.9)	-1.9 (2.4)

Adverse Events

Time Frame	Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks
Adverse Event Reporting Description	Safety Set comprised subjects who received the study drug at least once.
Arm/Group Title	Rebamipide 60 mg		Rebamipide 150 mg		Rebamipide 300 mg		Placebo
Arm/Group Description	Once daily intracolonial administration at a dose of 60 mg for 6 weeks		Once daily intracolonial administration at a dose of 150 mg for 6 weeks		Once daily intracolonial administration at a dose of 300 mg for 6 weeks		Once daily intracolonial administration of placebo for 6 weeks
All Cause Mortality
	Rebamipide 60 mg		Rebamipide 150 mg		Rebamipide 300 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Serious Adverse Events
	Rebamipide 60 mg		Rebamipide 150 mg		Rebamipide 300 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		2/29 (6.9%)		0/29 (0%)		1/31 (3.2%)
Ear and labyrinth disorders
Vertigo positional	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Gastrointestinal disorders
Colitis ulcerative	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		1/31 (3.2%)
Infections and infestations
Necrotising fasciitis	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Rebamipide 60 mg		Rebamipide 150 mg		Rebamipide 300 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/35 (62.9%)		20/29 (69%)		18/29 (62.1%)		22/31 (71%)
Blood and lymphatic system disorders
Iron deficiency anaemia	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Thrombocytopenia	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Cardiac disorders
Tachycardia	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Eye disorders
Asthenopia	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Gastrointestinal disorders
Abdominal distension	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		1/31 (3.2%)
Abdominal pain upper	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Cheilitis	0/35 (0%)		0/29 (0%)		0/29 (0%)		2/31 (6.5%)
Colitis ulcerative	2/35 (5.7%)		6/29 (20.7%)		1/29 (3.4%)		1/31 (3.2%)
Constipation	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Diarrhoea	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Gastritis	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Pancreatitis	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Rectal haemorrhage	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Stomach discomfort	2/35 (5.7%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Anal haemorrhage	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Haemorrhoidal haemorrhage	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Rectal tenesmus	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		3/31 (9.7%)
Gastrointestinal motility disorder	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Gastrointestinal inflammation	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		1/31 (3.2%)
General disorders
Feeling hot	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Malaise	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Pyrexia	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Hepatobiliary disorders
Hepatic function abnormal	1/35 (2.9%)		3/29 (10.3%)		1/29 (3.4%)		1/31 (3.2%)
Immune system disorders
Food allergy	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Seasonal allergy	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Infections and infestations
Furuncle	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Herpes simplex	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Hordeolum	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Nasopharyngitis	4/35 (11.4%)		3/29 (10.3%)		3/29 (10.3%)		4/31 (12.9%)
Upper respiratory tract infection	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Urinary tract infection	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Enteritis infectious	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Injury, poisoning and procedural complications
Contusion	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Investigations
Alanine aminotransferase increased	0/35 (0%)		0/29 (0%)		3/29 (10.3%)		1/31 (3.2%)
Aspartate aminotransferase increased	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		2/31 (6.5%)
Basophil count increased	0/35 (0%)		2/29 (6.9%)		0/29 (0%)		0/31 (0%)
Blood albumin decreased	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Blood cholesterol increased	1/35 (2.9%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Blood lactate dehydrogenase increased	1/35 (2.9%)		1/29 (3.4%)		0/29 (0%)		2/31 (6.5%)
Blood potassium decreased	0/35 (0%)		0/29 (0%)		0/29 (0%)		2/31 (6.5%)
Blood potassium increased	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Blood pressure increased	1/35 (2.9%)		2/29 (6.9%)		1/29 (3.4%)		2/31 (6.5%)
Blood triglycerides increased	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Blood urea decreased	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Blood uric acid increased	2/35 (5.7%)		0/29 (0%)		1/29 (3.4%)		1/31 (3.2%)
Eosinophil count decreased	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		1/31 (3.2%)
Eosinophil count increased	1/35 (2.9%)		3/29 (10.3%)		0/29 (0%)		1/31 (3.2%)
Gamma-glutamyltransferase increased	0/35 (0%)		1/29 (3.4%)		1/29 (3.4%)		0/31 (0%)
Glucose urine present	1/35 (2.9%)		1/29 (3.4%)		1/29 (3.4%)		1/31 (3.2%)
Haematocrit decreased	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Blood urine present	0/35 (0%)		1/29 (3.4%)		2/29 (6.9%)		0/31 (0%)
Haemoglobin decreased	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Liver function test abnormal	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Lymphocyte count abnormal	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Lymphocyte count decreased	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Monocyte count increased	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Neutrophil count decreased	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Neutrophil count increased	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Red blood cell count decreased	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Red blood cell count increased	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
White blood cell count decreased	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
White blood cell count increased	3/35 (8.6%)		3/29 (10.3%)		0/29 (0%)		4/31 (12.9%)
White blood cells urine positive	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Platelet count increased	2/35 (5.7%)		2/29 (6.9%)		1/29 (3.4%)		2/31 (6.5%)
Protein urine present	1/35 (2.9%)		2/29 (6.9%)		1/29 (3.4%)		1/31 (3.2%)
Urine ketone body present	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Blood alkaline phosphatase increased	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		1/31 (3.2%)
Metabolism and nutrition disorders
Diabetes mellitus	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Decreased appetite	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Musculoskeletal and connective tissue disorders
Sacroiliitis	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Muscle tightness	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Nervous system disorders
Dizziness	1/35 (2.9%)		0/29 (0%)		0/29 (0%)		0/31 (0%)
Dysgeusia	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Headache	3/35 (8.6%)		0/29 (0%)		3/29 (10.3%)		0/31 (0%)
Migraine	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Somnolence	0/35 (0%)		0/29 (0%)		1/29 (3.4%)		0/31 (0%)
Psychiatric disorders
Depression	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Insomnia	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Respiratory, thoracic and mediastinal disorders
Cough	0/35 (0%)		0/29 (0%)		0/29 (0%)		2/31 (6.5%)
Pharyngeal erythema	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Skin and subcutaneous tissue disorders
Acne	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Eczema asteatotic	0/35 (0%)		0/29 (0%)		0/29 (0%)		1/31 (3.2%)
Night sweats	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)
Urticaria	0/35 (0%)		1/29 (3.4%)		0/29 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.