A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01371721
• Collaborator: (none)
• Enrollment: 269
• Locations: 35
• Arm: 1
• Duration (Months): 44
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (DVS SR) in the treatment of child and adolescent outpatients with major depressive disorder (MDD).

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: DVS SR	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 269 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 6 Month, Open Label, Multi Center, Flexible Dose Extension Study To The B2061014 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Desvenlafaxine Succinate Sustained-Release	Drug: DVS SR; Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Experiencing a Treatment Emergent Adverse Event [Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study]

Secondary Outcome Measures

1. Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases [Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study]

   Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.

2. Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases [Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study]

   A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.

3. Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26 [Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study]

   A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.

4. Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases [Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study]

   Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.

5. Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases [Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study]

   A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Completed study B2061014 and who in the investigator's opinion would benefit from long term treatment with DVS SR

• Willingness and ability to comply with scheduled visits, treatment plan and procedures

Exclusion Criteria:

• Subject requires precaution against suicide

• Subject not in a generally healthy condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harmonex Neuroscience Research, Inc.	Dothan	Alabama	United States	36303
2	Dedicated Clinical Research	Goodyear	Arizona	United States	85395
3	University of Arizona Clinical and Translational Science Center (CATS)	Tucson	Arizona	United States	85724
4	University of Arizona College of Medicine Dept of Psychiatry	Tucson	Arizona	United States	85724
5	Arkansas Psychiatric Clinic Clinical Research Trials, P.A.	Little Rock	Arkansas	United States	72211
6	ATP Clinical Research, Incorporated	Costa Mesa	California	United States	92626
7	Behavioral Research Specialists, LLC	Glendale	California	United States	91206
8	Synergy Clinical Research Center	National City	California	United States	91950
9	Neuropsychiatric Research Center of Orange County	Orange	California	United States	92868
10	Pacific Clinical Research Medical Group	Orange	California	United States	92868
11	Elite Clinical Trials, Incorporated	Wildomar	California	United States	92595
12	Children's Hospital Colorado	Aurora	Colorado	United States	80045
13	Amedica Research Institute, Incorporated	Hialeah	Florida	United States	33013
14	Clinical Neuroscience Solutions, Inc.	Orlando	Florida	United States	32801
15	Kolin Research Group	Winter Park	Florida	United States	32789-3747
16	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
17	Institute for Behavioral Medicine, LLC	Smyrna	Georgia	United States	30080
18	Psychiatric Associates	Overland Park	Kansas	United States	66211
19	Lake Charles Clinical Trials,	Lake Charles	Louisiana	United States	70629
20	Precise Research Centers	Flowood	Mississippi	United States	39232
21	St. Charles Psychiatric Associates - Midwest Research Group	St. Charles	Missouri	United States	63303
22	Center for Psychiatry and Behavioral Medicine, Incorporated	Las Vegas	Nevada	United States	89128
23	North Star Medical Research, LLC	Middleburg Heights	Ohio	United States	44130
24	IPS Research Company	Oklahoma City	Oklahoma	United States	73103
25	Cutting Edge Research Group	Oklahoma City	Oklahoma	United States	73116
26	Paradigm Research Professionals, LLC	Oklahoma City	Oklahoma	United States	73118
27	Summit Research Network (Oregon), Incorporated	Portland	Oregon	United States	97210
28	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee	United States	38119
29	Focus & Balance, LLC	San Antonio	Texas	United States	78229
30	Grayline Clinical Drug Trials	Witchita Falls	Texas	United States	76309
31	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
32	Summit Research Network (Seattle) LLC	Seattle	Washington	United States	98104
33	Rogers Center for Research and Training, Incorporated	Milwaukee	Wisconsin	United States	53227
34	Hospital Aranda de la Parra, S.A. de C.V.	Leon	Guanajuato	Mexico	37000
35	CIT-Neuropsique, S.C.	Monterrey	Nuevo Leon	Mexico	64010

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01371721
• Other Study ID Numbers: B2061031; 3151A6-3357; 2008-002064-34
• First Posted: Jun 13, 2011
• Last Update Posted: Feb 8, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by Pfizer: Major Depressive Disorder; MDD; Depression
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

Participant Flow

Recruitment Details	Participants who completed the 8-week, double-blind treatment phase of Desvenlafaxine Succinate Sustained Release (DVS SR B2061014 NCT01372150) and completed the 1-week transition phase (week 9) of the short-term study were eligible to participate in this study (DVS SR B2061031).

Arm/Group Title	Placebo / DVS SR	Fluoxetine / DVS SR	Desvenlafaxine Succinate Sustained Release / DVS SR
Arm/Group Description	Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
Period Title: Overall Study
STARTED	88	89	92
Treated	87	89	92
COMPLETED	59	65	62
NOT COMPLETED	29	24	30

Baseline Characteristics

Arm/Group Title	Placebo / DVS SR	Fluoxetine / DVS SR	Desvenlafaxine Succinate Sustained Release / DVS SR	Total
Arm/Group Description	Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Total of all reporting groups
Overall Participants	87	89	92	268
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	12.5 (2.90)	12.4 (3.01)	12.8 (3.14)	12.6 (3.01)
Gender (Count of Participants)
Female	47 54%	39 43.8%	49 53.3%	135 50.4%
Male	40 46%	50 56.2%	43 46.7%	133 49.6%

Outcome Measures

1. Secondary Outcome

Title	Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases
Description	Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Time Frame	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Outcome Measure Data

Analysis Population Description

ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.

Arm/Group Title	Placebo / DVS SR	Fluoxetine / DVS SR	Desvenlafaxine Succinate Sustained Release / DVS SR	Combination
Arm/Group Description	Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
Measure Participants	55	61	56	172
Mean (Standard Deviation) [Score on a Scale]	-5.55 (10.80)	-6.41 (11.50)	-5.32 (7.29)	-5.78 (10.03)

2. Secondary Outcome

Title	Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases
Description	A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
Time Frame	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Outcome Measure Data

Analysis Population Description

ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.

Arm/Group Title	Placebo / DVS SR	Fluoxetine / DVS SR	Desvenlafaxine Succinate Sustained Release / DVS SR	Combination
Arm/Group Description	Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
Measure Participants	55	61	56	172
Mean (Standard Deviation) [Score on a Scale]	-0.78 (1.23)	-0.77 (1.16)	-0.82 (0.92)	-0.79 (1.10)

3. Secondary Outcome

Title	Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26
Description	A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time Frame	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Outcome Measure Data

Analysis Population Description

ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.

Arm/Group Title	Placebo / DVS SR	Fluoxetine / DVS SR	Desvenlafaxine Succinate Sustained Release / DVS SR	Combination
Arm/Group Description	Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
Measure Participants	55	61	56	172
Number [Percentage of Participants]	90.9 104.5%	93.4 104.9%	92.9 101%	92.4 34.5%

4. Secondary Outcome

Title	Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases
Description	Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Time Frame	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Outcome Measure Data

Analysis Population Description

ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.

Arm/Group Title	Placebo / DVS SR	Fluoxetine / DVS SR	Desvenlafaxine Succinate Sustained Release / DVS SR	Combination
Arm/Group Description	Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
Measure Participants	55	61	56	172
Number [Percentage of Participants]	74.5 85.6%	78.7 88.4%	73.2 79.6%	75.6 28.2%

5. Primary Outcome

Title	Percentage of Participants Experiencing a Treatment Emergent Adverse Event
Time Frame	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Outcome Measure Data

Analysis Population Description

Safety Population-includes all treatment-assigned participants who took at least one dose of investigational product in the period of study B2061031.

Arm/Group Title	Placebo / DVS SR	Fluoxetine / DVS SR	Desvenlafaxine Succinate Sustained Release / DVS SR	Combination
Arm/Group Description	Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
Measure Participants	87	89	92	268
Number [Percentage of Participants]	70.1 80.6%	75.3 84.6%	73.9 80.3%	73.1 27.3%

6. Secondary Outcome

Title	Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
Description	A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Outcome Measure Data

Analysis Population Description

ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.

Arm/Group Title	Placebo / DVS SR	Fluoxetine / DVS SR	Desvenlafaxine Succinate Sustained Release / DVS SR	Combination
Arm/Group Description	Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
Measure Participants	55	61	56	172
Very Much Improved	63.6 73.1%	63.9 71.8%	57.1 62.1%	61.6 23%
Much Improved	27.3 31.4%	29.5 33.1%	35.7 38.8%	30.8 11.5%
Minimally Improved	3.6 4.1%	3.3 3.7%	5.4 5.9%	4.1 1.5%
No Change	3.6 4.1%	1.6 1.8%	1.8 2%	2.3 0.9%
Minimally Worse	0.0 0%	1.6 1.8%	0.0 0%	0.6 0.2%
Much Worse	1.8 2.1%	0.0 0%	0.0 0%	0.6 0.2%
Very Much Worse	0.0 0%	0.0 0%	0.0 0%	0.0 0%

Adverse Events

Time Frame	Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Adverse Event Reporting Description	Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
Arm/Group Title	Placebo / DVS SR		Fluoxetine / DVS SR		Desvenlafaxine Succinate Sustained Release / DVS SR		Combination
Arm/Group Description	Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031		Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031		DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031		Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
All Cause Mortality
	Placebo / DVS SR		Fluoxetine / DVS SR		Desvenlafaxine Succinate Sustained Release / DVS SR		Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo / DVS SR		Fluoxetine / DVS SR		Desvenlafaxine Succinate Sustained Release / DVS SR		Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/87 (5.7%)		2/89 (2.2%)		3/92 (3.3%)		10/268 (3.7%)
Infections and infestations
Appendicitis	0/87 (0%)		0/89 (0%)		1/92 (1.1%)		1/268 (0.4%)
Psychiatric disorders
Aggression	1/87 (1.1%)		0/89 (0%)		0/92 (0%)		1/268 (0.4%)
Frustration	1/87 (1.1%)		0/89 (0%)		0/92 (0%)		1/268 (0.4%)
Hallucination, auditory	1/87 (1.1%)		0/89 (0%)		0/92 (0%)		1/268 (0.4%)
Irritability	1/87 (1.1%)		0/89 (0%)		0/92 (0%)		1/268 (0.4%)
Self injurious behaviour	1/87 (1.1%)		0/89 (0%)		0/92 (0%)		1/268 (0.4%)
Suicide attempt	3/87 (3.4%)		1/89 (1.1%)		1/92 (1.1%)		5/268 (1.9%)
Reproductive system and breast disorders
Ovarian cyst	0/87 (0%)		0/89 (0%)		1/92 (1.1%)		1/268 (0.4%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/87 (0%)		1/89 (1.1%)		0/92 (0%)		1/268 (0.4%)
Other (Not Including Serious) Adverse Events
	Placebo / DVS SR		Fluoxetine / DVS SR		Desvenlafaxine Succinate Sustained Release / DVS SR		Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/87 (54%)		61/89 (68.5%)		62/92 (67.4%)		170/268 (63.4%)
Gastrointestinal disorders
Abdominal discomfort	3/87 (3.4%)		3/89 (3.4%)		3/92 (3.3%)		9/268 (3.4%)
Abdominal pain upper	7/87 (8%)		8/89 (9%)		7/92 (7.6%)		22/268 (8.2%)
Constipation	2/87 (2.3%)		3/89 (3.4%)		1/92 (1.1%)		6/268 (2.2%)
Diarrhoea	3/87 (3.4%)		5/89 (5.6%)		2/92 (2.2%)		10/268 (3.7%)
Dyspepsia	2/87 (2.3%)		0/89 (0%)		3/92 (3.3%)		5/268 (1.9%)
Gastrooesophageal reflux disease	0/87 (0%)		1/89 (1.1%)		3/92 (3.3%)		4/268 (1.5%)
Nausea	9/87 (10.3%)		14/89 (15.7%)		8/92 (8.7%)		31/268 (11.6%)
Vomiting	5/87 (5.7%)		9/89 (10.1%)		6/92 (6.5%)		20/268 (7.5%)
General disorders
Fatigue	2/87 (2.3%)		3/89 (3.4%)		3/92 (3.3%)		8/268 (3%)
Infections and infestations
Bronchitis	0/87 (0%)		1/89 (1.1%)		4/92 (4.3%)		5/268 (1.9%)
Gastroenteritis	2/87 (2.3%)		3/89 (3.4%)		2/92 (2.2%)		7/268 (2.6%)
Gastroenteritis viral	4/87 (4.6%)		3/89 (3.4%)		5/92 (5.4%)		12/268 (4.5%)
Influenza	5/87 (5.7%)		1/89 (1.1%)		1/92 (1.1%)		7/268 (2.6%)
Nasopharyngitis	11/87 (12.6%)		4/89 (4.5%)		6/92 (6.5%)		21/268 (7.8%)
Pharyngitis	1/87 (1.1%)		2/89 (2.2%)		4/92 (4.3%)		7/268 (2.6%)
Pharyngitis streptococcal	2/87 (2.3%)		2/89 (2.2%)		3/92 (3.3%)		7/268 (2.6%)
Sinusitis	2/87 (2.3%)		3/89 (3.4%)		3/92 (3.3%)		8/268 (3%)
Upper respiratory tract infection	7/87 (8%)		9/89 (10.1%)		8/92 (8.7%)		24/268 (9%)
Viral infection	0/87 (0%)		3/89 (3.4%)		1/92 (1.1%)		4/268 (1.5%)
Injury, poisoning and procedural complications
Accidental overdose	0/87 (0%)		2/89 (2.2%)		3/92 (3.3%)		5/268 (1.9%)
Fall	0/87 (0%)		3/89 (3.4%)		2/92 (2.2%)		5/268 (1.9%)
Ligament sprain	0/87 (0%)		2/89 (2.2%)		3/92 (3.3%)		5/268 (1.9%)
Investigations
Blood pressure increased	0/87 (0%)		3/89 (3.4%)		3/92 (3.3%)		6/268 (2.2%)
Weight increased	7/87 (8%)		11/89 (12.4%)		12/92 (13%)		30/268 (11.2%)
Metabolism and nutrition disorders
Decreased appetite	3/87 (3.4%)		1/89 (1.1%)		1/92 (1.1%)		5/268 (1.9%)
Increased appetite	1/87 (1.1%)		2/89 (2.2%)		3/92 (3.3%)		6/268 (2.2%)
Musculoskeletal and connective tissue disorders
Back pain	2/87 (2.3%)		2/89 (2.2%)		3/92 (3.3%)		7/268 (2.6%)
Myalgia	4/87 (4.6%)		0/89 (0%)		2/92 (2.2%)		6/268 (2.2%)
Nervous system disorders
Dizziness	5/87 (5.7%)		5/89 (5.6%)		8/92 (8.7%)		18/268 (6.7%)
Headache	12/87 (13.8%)		16/89 (18%)		19/92 (20.7%)		47/268 (17.5%)
Psychiatric disorders
Insomnia	2/87 (2.3%)		5/89 (5.6%)		0/92 (0%)		7/268 (2.6%)
Irritability	3/87 (3.4%)		3/89 (3.4%)		2/92 (2.2%)		8/268 (3%)
Reproductive system and breast disorders
Dysmenorrhoea	1/87 (1.1%)		0/89 (0%)		5/92 (5.4%)		6/268 (2.2%)
Respiratory, thoracic and mediastinal disorders
Cough	6/87 (6.9%)		1/89 (1.1%)		4/92 (4.3%)		11/268 (4.1%)
Epistaxis	1/87 (1.1%)		3/89 (3.4%)		1/92 (1.1%)		5/268 (1.9%)
Oropharyngeal pain	6/87 (6.9%)		3/89 (3.4%)		1/92 (1.1%)		10/268 (3.7%)
Sinus congestion	0/87 (0%)		0/89 (0%)		3/92 (3.3%)		3/268 (1.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI must remove any previously undisclosed Confidential Information (other than the Study results themselves) before public release.