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The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients
This study uses a randomized, double-blind, placebo controlled, 3-period cross-over clinical trial design. During a screening epoch patient eligibility will be assessed. The screening epoch will be followed by a 21-day Run-in epoch during which patients will continue their inhaled corticosteroids use but be withdrawn from LABA-treatment and switched to short-acting bronchodilator-rescue medication. After the Run-in period patients will be randomized to one of the 6 treatment sequences and enter the first 7-day study treatment period. Treatment period one is followed by a 10 to 14 days washout period after which patients begin the second 7-day treatment period which is then followed by a second 10 to 14 days washout period followed by the third 7-day treatment period. At the end of each treatment period spirometry will be performed to assess the primary endpoint in terms of trough FEV1. The study population will consist of approximately 144 patients with asthma who have been treated in a stable regimen of ICS/LABA for at least 4 weeks prior to screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1(NVA237 50 ug/NVA237 25 ug/placebo) | Other | Treatment sequence: NVA 237 50 ug, 25 ug and placebo |
|
| 2(NVA237 50 ug/placebo/NVA237 25 ug) | Other | Treatment sequence: NVA 237 50 ug, placebo and 25 ug |
|
| 3 (NVA237 25 ug/NVA237 50 ug/placebo) | Other | Treatment sequence: NVA237 25 ug, 50 ug and placebo |
|
| 4 (NVA237 25 ug/placebo/NVA237 50 ug) | Other | Treatment sequence: NVA 237 25 ug, placebo and 50 ug |
|
| 5 (placebo/NVA237 50 ug/ NVA237 25 ug) | Other | Treatment sequence: Placebo, NVA237 50 ug and 25 ug |
|
| 6 (placebo/ NVA237 25 ug/NVA237 50 ug) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVA237 (glycopyrronium bromide) | Drug | In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 After One Week of Treatment, Point Estimate | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared to placebo in terms of trough FEV1 (mean of 23h 15 min and 23 h 45 min post -dose) following 1 week of treatment in the respective treatment period. Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 15 min and 23h 45 min post dose. | Following 1 week of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 AUC (5 Min-1 h) After One Week of Treatment | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 5min-1h) |
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Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | North Dartmouth | Massachusetts | 02747 | United States | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1(NVA237 50 ug/NVA237 25 ug/Placebo) | Treatment sequence: NVA 237 50 ug, 25 ug and placebo |
| FG001 | 2(NVA237 50 ug/Placebo/NVA237 25 ug) | Treatment sequence: NVA 237 50 ug, placebo and 25 ug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2018 | Dec 7, 2018 |
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| Other |
Treatment sequence: placebo, NVA237 25 ug and 50 ug |
|
| Placebo | Drug | In each treatment arm, patient will receive placebo |
|
| Following 1 week of treatment |
| FEV1 AUC (5 Min-4 h) After One Week of Treatment | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 5min-4h) | Following 1 week of treatment |
| FEV1 AUC (5 Min - 23 h 45 Min) After One Week of Treatment | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day AUC (5 min - 23 h 45 min) | Following 1 week of treatment |
| Peak FEV1 During 4 Hours Post-dose After 1 Week of Treatment | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Peak FEV1 following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect following 1 week of treatment was defined as the maximum FEV1 during the first 4 hour on that day. | Following 1 week of treatment |
| Trough Forced Vital Capacity (FVC) After 1 Week of Treatment | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of FVC following 1 week of treatment in respective treatment period. Trough Forced Vital Capacity (FVC) following 7 Days. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry | Following 1 week of treatment |
| Percent Change From Baseline in FEV1/FVC Ratio | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of FEV1/FVC ratio following 1 week of treatment in respective treatment period | Following 1 week of treatment |
| Mean Morning Peak Expiratory Flow (PEF) Following the 1-week Treatment Period | A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value | Following 1 week of treatment |
| Mean Evening Peak Expiratory Flow Rate (PEF) Following 1-week Treatment | A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits. LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates | Following 1 week of treatment |
| Mean Daily Number of Puffs of Rescue Medication During 1 Week of Treatment | A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. daytime and nighttime (combined) number of puffs is defined as the average of the respective number of puffs. | Following 1 week of treatment |
| St Louis |
| Missouri |
| 63141 |
| United States |
| Novartis Investigative Site | Skillman | New Jersey | 08558 | United States |
| Novartis Investigative Site | Raleigh | North Carolina | 27607 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504 | United States |
| Novartis Investigative Site | El Paso | Texas | 79903 | United States |
| Novartis Investigative Site | Erpent | 5100 | Belgium |
| Novartis Investigative Site | Hasselt | 3500 | Belgium |
| Novartis Investigative Site | Mechelen | 2800 | Belgium |
| Novartis Investigative Site | Berlin | 10119 | Germany |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
| Novartis Investigative Site | Großhansdorf | 22927 | Germany |
| Novartis Investigative Site | Lübeck | 23552 | Germany |
| Novartis Investigative Site | Wiesbaden | 65187 | Germany |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | 169-0073 | Japan |
| Novartis Investigative Site | Toshima-ku | Tokyo | 171-0014 | Japan |
| Novartis Investigative Site | Daugavpils | LVA | LV-5417 | Latvia |
| Novartis Investigative Site | Riga | LV 1002 | Latvia |
| Novartis Investigative Site | Riga | LV-1038 | Latvia |
| Novartis Investigative Site | Klaipėda | LT-92231 | Lithuania |
| Novartis Investigative Site | Klaipėda | LT-92288 | Lithuania |
| FG002 | 3 (NVA237 25 ug/NVA237 50 ug/Placebo) | Treatment sequence: NVA237 25 ug, 50 ug and placebo |
| FG003 | 4 (NVA237 25 ug/Placebo/NVA237 50 ug) | Treatment sequence: NVA 237 25 ug, placebo and 50 ug |
| FG004 | 5 (Placebo/NVA237 50 ug/ NVA237 25 ug) | Treatment sequence: Placebo, NVA237 50 ug and 25 ug |
| FG005 | 6 (Placebo/ NVA237 25 ug/NVA237 50 ug) | Treatment sequence: placebo, NVA237 25 ug and 50 ug |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants randomized to one of six treatment sequences |
| 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 |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Trough FEV1 After One Week of Treatment, Point Estimate | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared to placebo in terms of trough FEV1 (mean of 23h 15 min and 23 h 45 min post -dose) following 1 week of treatment in the respective treatment period. Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 15 min and 23h 45 min post dose. | The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. | Posted | Least Squares Mean | Standard Error | Liters | Following 1 week of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FEV1 AUC (5 Min-1 h) After One Week of Treatment | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 5min-1h) | The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. | Posted | Least Squares Mean | Standard Error | Liters | Following 1 week of treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FEV1 AUC (5 Min-4 h) After One Week of Treatment | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 5min-4h) | The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. | Posted | Least Squares Mean | Standard Error | Liters | Following 1 week of treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FEV1 AUC (5 Min - 23 h 45 Min) After One Week of Treatment | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day AUC (5 min - 23 h 45 min) | The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. | Posted | Least Squares Mean | Standard Error | Liters | Following 1 week of treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak FEV1 During 4 Hours Post-dose After 1 Week of Treatment | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Peak FEV1 following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect following 1 week of treatment was defined as the maximum FEV1 during the first 4 hour on that day. | The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence | Posted | Least Squares Mean | Standard Error | Liters | Following 1 week of treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Forced Vital Capacity (FVC) After 1 Week of Treatment | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of FVC following 1 week of treatment in respective treatment period. Trough Forced Vital Capacity (FVC) following 7 Days. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry | The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence | Posted | Least Squares Mean | Standard Error | Liters | Following 1 week of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in FEV1/FVC Ratio | To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of FEV1/FVC ratio following 1 week of treatment in respective treatment period | The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence | Posted | Mean | Standard Deviation | Percent change | Following 1 week of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Morning Peak Expiratory Flow (PEF) Following the 1-week Treatment Period | A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value | The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence | Posted | Least Squares Mean | Standard Error | L/min | Following 1 week of treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Evening Peak Expiratory Flow Rate (PEF) Following 1-week Treatment | A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits. LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates | The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence | Posted | Least Squares Mean | Standard Error | L/min | Following 1 week of treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Daily Number of Puffs of Rescue Medication During 1 Week of Treatment | A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. daytime and nighttime (combined) number of puffs is defined as the average of the respective number of puffs. | The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence | Posted | Least Squares Mean | Standard Error | Puffs/day | Following 1 week of treatment |
|
|
Following 1 week of treatment
AE additional description
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 | NVA237 50 ug | NVA237 50 ug capsule | 0 | 147 | 1 | 147 | 10 | 147 |
| EG001 | NVA237 25 ug | NVA237 25 ug capsule | 1 | 146 | 1 | 146 | 11 | 146 |
| EG002 | Placebo | Placebo | 0 | 146 | 0 | 146 | 11 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patellofemoral pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 1, 2016 | Dec 7, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| <0.001 |
| Linear Mixed Model (LMM) |
| 0.090 |
| 2-Sided |
| 95 |
| 0.047 |
| 0.132 |
| Other |
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| OG002 | Placebo | Placebo |
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