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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-001870-95 | Registry Identifier | EudraCT |
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The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Vortioxetine: 2.5 mg | Experimental |
| |
| Vortioxetine: 5 mg | Experimental |
| |
| Vortioxetine: 10 mg | Experimental |
| |
| Duloxetine: 60 mg | Other | Active reference |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | capsules; daily; orally |
| |
| Vortioxetine (Lu AA21004) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment | The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. | Baseline and Week 8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22209361 | Result | Baldwin DS, Loft H, Dragheim M. A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD). Eur Neuropsychopharmacol. 2012 Jul;22(7):482-91. doi: 10.1016/j.euroneuro.2011.11.008. Epub 2011 Dec 30. | |
| 32242018 | Derived |
Not provided
Not provided
The study consisted of a Screening Period; an 8-week Core Treatment Period; a 1-week double-blind downtaper period (Week 9); and a 4-week Safety Follow-up Period - the 4-week period after completion/withdrawal (Weeks 9 to 12).
The patients were recruited from psychiatric settings.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | capsules; daily; orally |
| FG001 | Vortioxetine 2.5 mg | encapsulated tablets; orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
2.5 mg/day; encapsulated tablets; orally |
|
|
| Vortioxetine (Lu AA21004) | Drug | 5 mg/day; encapsulated tablets; orally |
|
|
| Vortioxetine (Lu AA21004) | Drug | 10 mg/day; encapsulated tablets; orally |
|
|
| Duloxetine | Drug | 60 mg/day; encapsulated capsules; orally |
|
|
| Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | Week 8 |
| Change in Clinical Status Using CGI-I Score at Week 8 | The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. | Week 8 |
| Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 | Baseline and Week 8 |
| Change From Baseline in SDS Total Score After 8 Weeks of Treatment | The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. | Baseline and Week 8 |
| Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | Week 8 |
| Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment | The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. | Baseline and Week 8 |
| Change From Baseline in CGI-S Score After 8 Weeks of Treatment | The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. | Baseline and Week 8 |
| Change From Baseline in ASEX Total Score After 8 Weeks of Treatment | The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction. | Baseline and Week 8 |
| Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Theroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5. |
| 31818787 | Derived | Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13. |
| 31087825 | Derived | Belzeaux R, Fiori LM, Lopez JP, Boucekine M, Boyer L, Blier P, Farzan F, Frey BN, Giacobbe P, Lam RW, Leri F, MacQueen GM, Milev R, Muller DJ, Parikh SV, Rotzinger S, Soares CN, Uher R, Foster JA, Kennedy SH, Turecki G. Predicting Worsening Suicidal Ideation With Clinical Features and Peripheral Expression of Messenger RNA and MicroRNA During Antidepressant Treatment. J Clin Psychiatry. 2019 May 7;80(3):18m12556. doi: 10.4088/JCP.18m12556. |
| 27780334 | Derived | McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744. |
| FG002 |
| Vortioxetine 5 mg |
encapsulated tablets; orally |
| FG003 | Vortioxetine 10 mg | encapsulated tablets; orally |
| FG004 | Duloxetine 60 mg | encapsulated capsules; orally |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid postbaseline assessment of the primary efficacy variable
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | capsules; daily; orally |
| BG001 | Vortioxetine 2.5 mg | encapsulated tablets; orally |
| BG002 | Vortioxetine 5 mg | encapsulated tablets; orally |
| BG003 | Vortioxetine 10 mg | encapsulated tablets; orally |
| BG004 | Duloxetine 60 mg | encapsulated capsules; orally |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| MADRS | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| HAM-D-24 | The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| CGI-S | The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| SDS | The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| HAM-A | The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. | Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA) | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment | The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. | FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | FAS; LOCF; Logistic Regression | Posted | Number | percentage of patients | Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Clinical Status Using CGI-I Score at Week 8 | The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. | FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 | Patients With Baseline HAM-A Total Score >=20: FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SDS Total Score After 8 Weeks of Treatment | The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. | SDS is a patient-reported outcome. The SDS Total Score is the sum of work, social life, or leisure activities, and home life or family responsibilities. FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | FAS; LOCF; Logistic Regression | Posted | Number | percentage of patients | Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment | The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. | FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CGI-S Score After 8 Weeks of Treatment | The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. | FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in ASEX Total Score After 8 Weeks of Treatment | The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction. | FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
|
Serious Adverse Events: 8-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 8-week double-blind treatment period
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 3 | 148 | 64 | 148 | |||
| EG001 | Vortioxetine 2.5 mg | 1 | 155 | 61 | 155 | |||
| EG002 | Vortioxetine 5 mg | 3 | 157 | 63 | 157 | |||
| EG003 | Vortioxetine 10 mg | 2 | 151 | 62 | 151 | |||
| EG004 | Duloxetine 60 mg | 2 | 155 | 93 | 155 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Middle ear effusion | Ear and labyrinth disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MEDDRA12_1 | Non-systematic Assessment |
| |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA12_1 | Non-systematic Assessment |
| |
| Serotonin syndrome | Nervous system disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDDRA12_1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA12_1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA12_1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA12_1 | Non-systematic Assessment |
|
The main publication has to be published before any sub-publications. H. Lundbeck A/S follows the Vancouver declaration with respect to authorship.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck A/S | H. Lundbeck A/S | +45 3630 1311 | LundbeckClinicalTrials@lundbeck.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints. | ANCOVA | 0.1847 | Since p-value >0.025, hierarchically testing stopped here. | Mean Difference (Final Values) | -1.50 | Standard Error of the Mean | 1.13 | 2-Sided | 95 | -3.73 | 0.72 | To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025. | No | Superiority or Other |
| ANCOVA | 0.2187 | This dose was not in the testing sequence. A nominal p-value is provided. | Mean Difference (Final Values) | -1.38 | Standard Error of the Mean | 1.12 | 2-Sided | 95 | -3.59 | 0.82 | No | Superiority or Other |
| ANCOVA | 0.0741 | This treatment arm was not in the testing sequence. A nominal p-value is provided. | Mean Difference (Final Values) | -2.04 | Standard Error of the Mean | 1.14 | 2-Sided | 95 | -4.27 | 0.20 | No | Superiority or Other |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
encapsulated capsules; orally
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
encapsulated tablets; orally |
| OG004 | Duloxetine 60 mg | encapsulated capsules; orally |
|
|
|
| Participants |
|
|
|
| Duloxetine 60 mg |
encapsulated capsules; orally |
|
|
|
encapsulated capsules; orally
|
|
|
| OG004 | Duloxetine 60 mg | encapsulated capsules; orally |
|
|
|