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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-HMGW | Other Identifier | Eli Lilly and Company | |
| CTRI/2011/07/001866 | Registry Identifier | Clinical Trials Registry India |
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The purpose of this study is to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).
This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental | Blinded treatment period: 30mg or 60mg once daily for 13 weeks Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks Taper period: 30mg Duloxetine or placebo once daily for 1 week. |
|
| Placebo | Placebo Comparator | Blinded treatment period:Placebo once daily for 13 weeks Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks Taper period: 30mg Duloxetine or placebo once daily for 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item | Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means. | Baseline, 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items | The Brief Pain Inventory (BPI) - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work. MMRM model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce LS means. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NoesisPharma | Phoenix | Arizona | 85032 | United States | ||
| Loma Linda University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31138224 | Derived | Upadhyaya HP, Arnold LM, Alaka K, Qiao M, Williams D, Mehta R. Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a randomized controlled trial. Pediatr Rheumatol Online J. 2019 May 28;17(1):27. doi: 10.1186/s12969-019-0325-6. |
| Label | URL |
|---|---|
| Click here for more information about this study: A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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13 week Double-Blind Treatment Phase (Acute Phase), followed by 26 week Open-Label Extension Treatment Phase (Extension Phase), followed by 1 week Taper/Discontinuation Phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine/Duloxetine | Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase). Participants who received higher doses of Duloxetine in acute & extension phase received gradually lower doses of duloxetine & participants on lower doses of Duloxetine in acute phase received placebo during 1-week tapering phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Treatment (Acute Phase) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Protocol | Oct 25, 2010 | Mar 27, 2018 |
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| Placebo | Drug | Administered orally |
|
| Baseline, 13 weeks |
| Maintenance Effect in Acute Phase Responders on the Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item | Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function.Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Acute phase responders: Participants with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase. | Baseline (Extension Phase), 39 weeks |
| Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks | Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF). | 13 weeks |
| Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks | Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF). | 13 weeks |
| Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores | Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | Baseline, 13 weeks |
| Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score | Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value. | Baseline, 13 weeks |
| Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score | Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value. | Baseline, 13 weeks |
| Change From Baseline in Functional Disability Inventory Child Form (FDI-Child) | Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | Baseline, 13 weeks |
| Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent) | Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | Baseline, 13 weeks |
| Change From Baseline in Children's Depression Inventory (CDI) | Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | Baseline, 13 weeks |
| Change From Baseline in Multidimensional Anxiety Scale for Children (MASC) | Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | Baseline, 13 weeks |
| Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items | The BPI - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | Baseline (extension phase), 39 weeks |
| Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores | Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | Baseline (extension phase), 39 weeks |
| Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score | Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value. | Baseline (extension phase), 39 weeks |
| Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score | Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value. | Baseline (extension phase), 39 weeks |
| Change From Baseline in Functional Disability Inventory Child Form (FDI-child) | Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | Baseline (extension phase), 39 weeks |
| Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent) | Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | Baseline (extension phase), 39 weeks |
| Change From Baseline in Children's Depression Inventory (CDI) | Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | Baseline (extension phase), 39 weeks |
| Change From Baseline in Multidimensional Anxiety Scale for Children (MASC) | Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.ANCOVA model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | Baseline (extension phase), 39 weeks |
| Loma Linda |
| California |
| 92354 |
| United States |
| Synergy Clinical Research | National City | California | 91950 | United States |
| Connecticut Clinical Trials LLC | Cromwell | Connecticut | 06416 | United States |
| Associated Neurologists of Southern Connecticut | Fairfield | Connecticut | 06824 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Institute for Behavioral Medicine | Smyrna | Georgia | 30080 | United States |
| Riley Hosptial for Children | Indianapolis | Indiana | 46202 | United States |
| Kentucky Medical Research Center | Lexington | Kentucky | 40504 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Healthy Perspectives Innovative Mental Health Services, PL | Nashua | New Hampshire | 03060 | United States |
| Albuquerque Neurosciences | Albuquerque | New Mexico | 87109 | United States |
| Bioscience Research, LLC | Mount Kisco | New York | 10549 | United States |
| Richmond Behavorial Associates | Staten Island | New York | 10312 | United States |
| Neurobehavioral Clinical Research | Canton | Ohio | 44718 | United States |
| Univ of Cincinnati College of Medicine | Cincinnati | Ohio | 45219 | United States |
| North Star Research | Middleburg Heights | Ohio | 44130 | United States |
| Neuropsychiatric Center | Oklahoma City | Oklahoma | 73109 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| CRI Lifetree | Philadelphia | Pennsylvania | 19139 | United States |
| Holston Medical Group Clinical Research | Kingsport | Tennessee | 37660 | United States |
| Arthritis and Osteoporosis Center of South Texas | San Antonio | Texas | 78232 | United States |
| Bateman Horne Center of Excellence | Salt Lake City | Utah | 84102 | United States |
| NeuroScience, Inc. | Herndon | Virginia | 20170-2613 | United States |
| Advanced Pain Management | Virginia Beach | Virginia | 23505 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007-4209 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Miguel de Tucumán | T4000AXL | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chennai | 600003 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyderabad | 500034 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mysore | 570004 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Raipur | 492001 | India |
| Centro de Investigaciones Clinicas | San Juan | 00912 | Puerto Rico |
| Centro Pediatrico Paseos | San Juan | 00926 | Puerto Rico |
| FG001 | Placebo/Duloxetine | Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase). Participants who received placebo in acute phase received placebo & participants who received higher doses of Duloxetine in extension phase received gradually lower doses of duloxetine during1-week tapering phase. |
| Received at Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Open Label Treatment (Extension Phase) |
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| Taper Phase |
|
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine | Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase). Participants who received higher doses of Duloxetine in acute & extension phase received gradually lower doses of duloxetine & participants on lower doses of Duloxetine in acute phase received placebo during 1-week tapering phase. |
| BG001 | Placebo | Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase). Participants who received placebo in acute phase received placebo & participants who received higher doses of Duloxetine in extension phase received gradually lower doses of duloxetine during 1-week tapering phase. |
| BG002 | 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 | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Brief Pain Inventory (BPI) Modified short form (SF) Adolescent version (AV) | BPI Modified SF AV is a scale that measures severity & interference of pain. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). 4 questions assessing severity for worst pain, least pain, average pain in past 24 hours, & pain right now.Interference scores range from 0 (does not interfere) to 10 (completely interferes).7 questions assessing interference of pain in past 24 hours on general activity, mood, walking ability, normal work, relations with other people, sleep, & enjoyment of life. Adolescent Version has 8th question for interference of pain on school work. | All randomized participants who had baseline BPI score. | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Pediatric Pain Questionnaire (PPQ) | Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 millimeter (mm) VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain). | All randomized participants who had baseline PPQ score. | Mean | Standard Deviation | mm |
| |||||||||||||
| Clinical Global Impression (CGI) Severity: Mental Illness | Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill). | All randomized participants who had baseline CGI mental illness score. | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Clinical Global Impression (CGI) Severity: Overall Illness | Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of Juvenile Primary Fibromyalgia Syndrome (JPFS), including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit. | All randomized participants who had baseline CGI overall illness score. | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Functional Disability Inventory (FDI) Child score | Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. | All randomized participants who had baseline FDI child score. | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Functional Disability Inventory (FDI) Parent Score | Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. | All randomized participants who had baseline FDI parent score. | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Children's Depression Inventory (CDI) | Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression. | All randomized participants who had baseline CDI score. | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Multidimensional Anxiety Scale for Children (MASC) | MASC consists of 39 items that comprise 4 factors. Each item is scored on a 0 to 3-point scale (0-never to 3-often).
| All randomized participants who had baseline MASC score. | 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 to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item | Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means. | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 13 weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items | The Brief Pain Inventory (BPI) - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work. MMRM model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce LS means. | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI severity & interferences items score. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 13 weeks |
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| Secondary | Maintenance Effect in Acute Phase Responders on the Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item | Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function.Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Acute phase responders: Participants with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase. | All randomized participants in duloxetine only arm with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Extension Phase), 39 weeks |
|
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| Secondary | Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks | Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF). | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score. | Posted | Count of Participants | Participants | 13 weeks |
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| Secondary | Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks | Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF). | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score. | Posted | Count of Participants | Participants | 13 weeks |
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| Secondary | Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores | Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline PPQ score. | Posted | Least Squares Mean | Standard Error | mm | Baseline, 13 weeks |
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| Secondary | Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score | Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CGI-S overall illness score. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 13 weeks |
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| Secondary | Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score | Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CGI-S mental illness score. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 13 weeks |
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| Secondary | Change From Baseline in Functional Disability Inventory Child Form (FDI-Child) | Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline FDI child scale score. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 13 weeks |
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| Secondary | Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent) | Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline FDI-parent scale score. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 13 weeks |
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| Secondary | Change From Baseline in Children's Depression Inventory (CDI) | Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CDI score. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 13 weeks |
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| Secondary | Change From Baseline in Multidimensional Anxiety Scale for Children (MASC) | Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline MASC score. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 13 weeks |
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| Secondary | Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items | The BPI - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline BPI severity & interferences items scores. Baseline for extension phase is defined as the last non-missing value in acute phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (extension phase), 39 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores | Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline PPQ measurement. Baseline for extension phase is defined as the last non-missing value in acute phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (extension phase), 39 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score | Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CGI overall illness measurement. Baseline for extension phase is defined as the last non-missing value in acute phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (extension phase), 39 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score | Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CGI mental Illness measurement. Baseline for extension phase is defined as the last non-missing value in acute phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (extension phase), 39 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Disability Inventory Child Form (FDI-child) | Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline FDI-child measurement. Baseline for extension phase is defined as the last non-missing value in acute phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (extension phase), 39 weeks |
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| Secondary | Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent) | Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline FDI-parent measurement. Baseline for extension phase is defined as the last non-missing value in acute phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (extension phase), 39 weeks |
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| Secondary | Change From Baseline in Children's Depression Inventory (CDI) | Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CDI measurement. Baseline for extension phase is defined as the last non-missing value in acute phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (extension phase), 39 weeks |
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| Secondary | Change From Baseline in Multidimensional Anxiety Scale for Children (MASC) | Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.ANCOVA model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. | All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline MASC measurement. Baseline for extension phase is defined as the last non-missing value in acute phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (extension phase), 39 weeks |
|
up to 39 weeks
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 | Duloxetine - Acute | Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks during Acute phase. | 0 | 91 | 2 | 91 | 74 | 91 |
| EG001 | Placebo - Acute | Participants received Placebo orally once daily (QD) for 13 weeks during Acute phase. | 0 | 93 | 0 | 93 | 58 | 93 |
| EG002 | Duloxetine/Duloxetine - Extension | Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase). | 0 | 74 | 3 | 74 | 52 | 74 |
| EG003 | Placebo/Duloxetine - Extension | Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase). | 0 | 75 | 3 | 75 | 54 | 75 |
| EG004 | Duloxetine 60/Duloxetine 30 - Taper | Participants who received 60mg Duloxetine in acute & extension phase received 30mg of Duloxetine in taper phase. | 0 | 77 | 0 | 77 | 7 | 77 |
| EG005 | Placebo/Placebo - Taper | Participants who received placebo or 30mg Duloxetine in acute phase received placebo in Taper phase. | 0 | 3 | 0 | 3 | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment (a) | Jul 13, 2011 | Mar 27, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2017 | Mar 27, 2018 | SAP_002.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment (b) | Apr 24, 2013 | Mar 27, 2018 | Prot_003.pdf |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Lack of Efficacy |
|
| Parent/Guardian Decision |
|
| Withdrawal by Subject |
|
| Sponsor Decision |
|
| Physician Decision |
|
| Lack of Efficacy |
|
| Parent/Guardian Decision |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
|
|
|
|
| Argentina |
|
|
| United States |
|
|
| India |
|
|
|
| Worst Pain |
|
|
| Least Pain |
|
|
| Pain Right Now |
|
|
| General Activity |
|
|
| Mood |
|
|
| Walking Ability |
|
|
| Normal Work |
|
|
| Relations with other people |
|
|
| Sleep |
|
|
| Enjoyment of Life |
|
|
| School Work |
|
|
|
| Worst Pain |
|
|
| pain now |
|
|
|
|
|
|
|
|
| Harm Avoidance |
|
|
| Social Anxiety |
|
|
| Separation/Panic |
|
|
| Total Score |
|
|
Participants received Placebo orally once daily (QD) for 13 weeks. |
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
| Placebo - Acute |
Participants received Placebo orally once daily (QD) for 13 weeks. |
|
|
|
| OG001 | Placebo/Duloxetine - Extension Phase | Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase). |
|
|
|
|
Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
|
|
|
|
Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
|
|
|
|
|
|
| OG001 | Placebo/Duloxetine - Extension Phase | Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase). |
|
|