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This study was terminated early due to company decision. Part B was never conducted.
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This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Part A: Placebo every 12 hours for 4 weeks |
|
| AGN 203818 3 mg | Experimental | Part A: 3 mg AGN 203818 every 12 hours for 4 weeks |
|
| AGN 203818 20 mg | Experimental | Part A: 20 mg AGN 203818 every 12 hours for 4 weeks |
|
| AGN 203818 60 mg | Experimental | Part A: 60 mg AGN 203818 every 12 hours for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Part A: Placebo every 12 hours for 4 weeks |
| |
| AGN 203818 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Daily-Average-Pain Score at Week 4 | Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement). | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Change from baseline in the SF-BPI average pain question score at week 4. The SF-BPI is a patient-rated questionnaire that assesses certain aspects of pain including location, intensity, and interference with certain daily activities. The "average pain" question was rated on an 11-point scale (where 0=no pain and 10=worst pain imaginable). A negative number change from baseline indicates a reduction in average pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canton | Ohio | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Part A: Placebo every 12 hours for 4 weeks |
| FG001 | AGN 203818 3 mg | Part A: 3 mg AGN 203818 every 12 hours for 4 weeks |
| FG002 | AGN 203818 20 mg | Part A: 20 mg AGN 203818 every 12 hours for 4 weeks |
| FG003 | AGN 203818 60 mg | Part A: 60 mg AGN 203818 every 12 hours for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Part A: Placebo every 12 hours for 4 weeks |
| BG001 | AGN 203818 3 mg | Part A: 3 mg AGN 203818 every 12 hours for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Mean Daily-Average-Pain Score at Week 4 | Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement). | Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 4 |
|
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The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Part A: Placebo every 12 hours for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
This study was terminated early due to company decision. Only Part A results are presented; Part B was never conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Drug |
Part A: AGN 203818 3 mg every 12 hours for 4 weeks |
|
| AGN 203818 | Drug | Part A: AGN 203818 20 mg every 12 hours for 4 weeks |
|
| AGN 203818 | Drug | Part A: AGN 203818 60 mg every 12 hours for 4 weeks |
|
| Baseline, Week 4 |
| Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Change from baseline in FIQ total score of physical impairment at week 4. The FIQ is a disease-specific questionnaire consisting of 10 questions and visual analog scales regarding functional disability, pain intensity, sleep function, stiffness, anxiety, depression, and overall sense of wellbeing. Each question is scored from 0 to 10 with 0 = no impairment (best) and 10 indicates maximum impairment (worst), for a minimum possible score (best) of 0 and a maximum possible (worst) total score of 100. A negative number change from baseline indicates improvement. | Baseline, Week 4 |
| Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | PGIC status for fibromyalgia syndrome at week 4. The PGIC consists of a self-evaluation by the patient of the overall change of their fibromyalgia syndrome since the beginning of the study, rated on a 7-point scale (score of 1-3 = very much improved to minimally improved; 4= no change; 5-7 = minimally worse to very much worse). Results are presented for the percentage of patients reporting each status: "improved"= score of 1-3; "no change"=score of 4; and "worse"=score of 5-7. | Week 4 |
| Geneva |
| Switzerland |
| Stanmore | United Kingdom |
| BG002 | AGN 203818 20 mg | Part A: 20 mg AGN 203818 every 12 hours for 4 weeks |
| BG003 | AGN 203818 60 mg | Part A: 60 mg AGN 203818 every 12 hours for 4 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| AGN 203818 3 mg |
Part A: 3 mg AGN 203818 every 12 hours for 4 weeks |
| OG002 | AGN 203818 20 mg | Part A: 20 mg AGN 203818 every 12 hours for 4 weeks |
| OG003 | AGN 203818 60 mg | Part A: 60 mg AGN 203818 every 12 hours for 4 weeks |
|
|
| Secondary | Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Change from baseline in the SF-BPI average pain question score at week 4. The SF-BPI is a patient-rated questionnaire that assesses certain aspects of pain including location, intensity, and interference with certain daily activities. The "average pain" question was rated on an 11-point scale (where 0=no pain and 10=worst pain imaginable). A negative number change from baseline indicates a reduction in average pain. | Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 4 |
|
|
|
| Secondary | Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Change from baseline in FIQ total score of physical impairment at week 4. The FIQ is a disease-specific questionnaire consisting of 10 questions and visual analog scales regarding functional disability, pain intensity, sleep function, stiffness, anxiety, depression, and overall sense of wellbeing. Each question is scored from 0 to 10 with 0 = no impairment (best) and 10 indicates maximum impairment (worst), for a minimum possible score (best) of 0 and a maximum possible (worst) total score of 100. A negative number change from baseline indicates improvement. | Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 4 |
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | PGIC status for fibromyalgia syndrome at week 4. The PGIC consists of a self-evaluation by the patient of the overall change of their fibromyalgia syndrome since the beginning of the study, rated on a 7-point scale (score of 1-3 = very much improved to minimally improved; 4= no change; 5-7 = minimally worse to very much worse). Results are presented for the percentage of patients reporting each status: "improved"= score of 1-3; "no change"=score of 4; and "worse"=score of 5-7. | Modified Intent-To-Treat (m-ITT). The m-ITT population included all randomized patients who started study (randomized) and who received the study medication with at least one post-treatment mean daily-average-pain score. | Posted | Number | Percentage of Patients | Week 4 |
|
|
|
| 0 |
| 52 |
| 36 |
| 52 |
| EG001 | AGN 203818 3 mg | Part A: 3 mg AGN 203818 every 12 hours for 4 weeks | 0 | 53 | 37 | 53 |
| EG002 | AGN 203818 20 mg | Part A: 20 mg AGN 203818 every 12 hours for 4 weeks | 1 | 52 | 34 | 52 |
| EG003 | AGN 203818 60 mg | Part A: 60 mg AGN 203818 every 12 hours for 4 weeks | 2 | 52 | 38 | 52 |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
A disclosure restriction on the PI is that 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| D009422 |
| Nervous System Diseases |
| Change from Baseline at Week 4 |
|
| Change from Baseline at Week 4 |
|
| No Change |
|
| Worse |
|