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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8435-002 | Other Identifier | Merck Protocol | |
| Org 172012 | Other Identifier | Organon Protocol |
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The purpose of this study is to evaluate the effectiveness of Org 25935 vs. placebo given in combination with cognitive-behavioral therapy (CBT) to reduce the symptoms of panic disorder. It is hypothesized that treatment with Org 25935 at a dose of 4 mg or 12 mg will differ significantly from placebo with respect to the Panic Disorder Severity Scale (PDSS) total score over 3 weeks of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg Org 25935 | Experimental | Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. |
|
| 12 mg Org 25935 | Experimental | Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. |
|
| Placebo | Placebo Comparator | Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioral therapy | Behavioral | Participants underwent 5 weekly CBT session (sessions were 60-90 minutes in duration). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT) | The mean change in PDSS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity). | Screening and Day 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PDSS Score From Baseline to Visit 4 | The mean change in PDSS score from baseline (Screening) to Visit 4 (Day 22) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22394471 | Derived | Nations KR, Smits JA, Tolin DF, Rothbaum BO, Hofmann SG, Tart CD, Lee A, Schipper J, Sjogren M, Xue D, Szegedi A, Otto MW. Evaluation of the glycine transporter inhibitor Org 25935 as augmentation to cognitive-behavioral therapy for panic disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2012 May;73(5):647-53. doi: 10.4088/JCP.11m07081. Epub 2012 Feb 21. |
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Adult (18 to 65 years of age) male and female participants with a diagnosis of current panic disorder (PD; with or without agoraphobia [AGP]) were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 mg Org 25935 | Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. |
| FG001 | 12 mg Org 25935 | Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. |
| FG002 | Placebo | Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 mg Org 25935 | Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. |
| BG001 | 12 mg Org 25935 | Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT) | The mean change in PDSS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity). | The Intent-to-Treat (ITT) population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS assessments at Screening and EOT. | Posted | Mean | Standard Deviation | PDSS Score | Screening and Day 36 |
|
Up to 59 days
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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 | Org 25935 4 mg | Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Develpment | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| C520612 | N-methyl-N-(6-methoxy-1-phenyl-1,2,3,4-tetrahydronaphthalen-2-ylmethyl)aminomethylcarboxylic acid |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Org 25935 | Drug | 4 mg Org 25935 is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period. |
|
| Org 25935 | Drug | 12 mg Org 25935 is given in tablet form, a single dose two hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a two-week period. |
|
| Placebo | Drug | Placebo is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period. |
|
| Screening and Visit 4 (Day 22) |
| Change in PDSS Score From Baseline to Follow-Up | The mean change in PDSS score from baseline (Screening) to Follow-Up (Day 59) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity). | Screening and Follow-Up (Day 59) |
| Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening | The SCID-I/P with Psy Screen, Panic Disorder Module was used to score participants' PD (with [w] or without [w/o] AGP) as being current (full criteria for the disorder met), in full remission (IFR) [there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder], or in partial remission (IPR) [full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain] at baseline (Screening). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders. | Screening |
| SCID-I/P With Psy Screen Score at EOT | The SCID-I/P with Psy Screen, Panic Disorder Module, was used to score participants' PD (w or w/o AP) as being current (full criteria for the disorder are met), IFR (there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder), or IPR (full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain) at EOT (Day 36). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders. | Day 36 |
| Change in Clinical Global Impression-Severity (CGI-S) Score | The mean change in CGI-S score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The CGI-S is a clinician-rated instrument used to assess global severity of general anxiety symptoms. The instrument consists of a 7-point scale that the clinician uses to rate the severity of the patient's illness, from 1 (normal, not at all ill) to 7 (extremely ill). | Screening and Day 36 |
| Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score | The mean change in SIGH-A score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The SIGH-A is a 14-item scale to assess anxiety in a clinical population. Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of zero to a maximum of 56 (higher scores indicate greater anxiety severity). | Screening and Day 36 |
| Change in Anxiety Sensitivity Index (ASI) Score | The mean change in ASI score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The ASI is a 16-item self-report questionnaire that assesses fear of anxiety sensations. Each item is scored on a 5-point Likert scale (0 to 4) with total score ranging from a minimum of 0 to a maximum of 64 (higher scores indicate greater fear of anxiety sensations). | Screening and Day 36 |
| Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score | The mean change in MADRS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The MADRS is a 10-item clinical-administered scale designed to assess severity of depression. Each item is rated from 0 to 6, with total score ranging from 0 to 60 (higher MADRS scores indicate more severe depression). | Screening and Day 36 |
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score | The mean change in Q-LES-Q score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The Q-LES-Q is a self-report questionnaire rating 16 aspects of quality of life, including physical health and mood. Scores range from 0 ("very poor") to 5 ("very good"), with total score ranging from 0 to 80 (higher O-LES-Q scores indicate greater quality of life). | Screening and Day 36 |
| Number of Participants Experiencing an Adverse Event (AE) | The number of participants experiencing one or more AEs throughout the study period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to 59 days |
| Number of Participants Discontinuing Study Therapy Due to AEs | The number of participants withdrawing from study treatment during the treatment period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to 2 weeks |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | Placebo | Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 12 mg Org 25935 | Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. |
| OG002 | Placebo | Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period. |
|
|
|
| Secondary | Change in PDSS Score From Baseline to Visit 4 | The mean change in PDSS score from baseline (Screening) to Visit 4 (Day 22) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity). | The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and PDSS scores at Screening and Visit 4. | Posted | Mean | Standard Deviation | PDSS Score | Screening and Visit 4 (Day 22) |
|
|
|
|
| Secondary | Change in PDSS Score From Baseline to Follow-Up | The mean change in PDSS score from baseline (Screening) to Follow-Up (Day 59) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity). | The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS scores at Screening and Follow-Up. | Posted | Mean | Standard Deviation | PDSS Score | Screening and Follow-Up (Day 59) |
|
|
|
|
| Secondary | Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening | The SCID-I/P with Psy Screen, Panic Disorder Module was used to score participants' PD (with [w] or without [w/o] AGP) as being current (full criteria for the disorder met), in full remission (IFR) [there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder], or in partial remission (IPR) [full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain] at baseline (Screening). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders. | The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at Screening. | Posted | Number | Participants | Screening |
|
|
|
| Secondary | SCID-I/P With Psy Screen Score at EOT | The SCID-I/P with Psy Screen, Panic Disorder Module, was used to score participants' PD (w or w/o AP) as being current (full criteria for the disorder are met), IFR (there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder), or IPR (full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain) at EOT (Day 36). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders. | The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at EOT. | Posted | Number | Participants | Day 36 |
|
|
|
| Secondary | Change in Clinical Global Impression-Severity (CGI-S) Score | The mean change in CGI-S score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The CGI-S is a clinician-rated instrument used to assess global severity of general anxiety symptoms. The instrument consists of a 7-point scale that the clinician uses to rate the severity of the patient's illness, from 1 (normal, not at all ill) to 7 (extremely ill). | The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had CGI-S scores at Screening and EOT. | Posted | Mean | Standard Deviation | CGI-S Score | Screening and Day 36 |
|
|
|
| Secondary | Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score | The mean change in SIGH-A score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The SIGH-A is a 14-item scale to assess anxiety in a clinical population. Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of zero to a maximum of 56 (higher scores indicate greater anxiety severity). | The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SIGH-A scores at Screening and EOT. | Posted | Mean | Standard Deviation | SIGH-A Score | Screening and Day 36 |
|
|
|
|
| Secondary | Change in Anxiety Sensitivity Index (ASI) Score | The mean change in ASI score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The ASI is a 16-item self-report questionnaire that assesses fear of anxiety sensations. Each item is scored on a 5-point Likert scale (0 to 4) with total score ranging from a minimum of 0 to a maximum of 64 (higher scores indicate greater fear of anxiety sensations). | The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had ASI scores at Screening and EOT. | Posted | Mean | Standard Deviation | ASI Score | Screening and Day 36 |
|
|
|
|
| Secondary | Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score | The mean change in MADRS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The MADRS is a 10-item clinical-administered scale designed to assess severity of depression. Each item is rated from 0 to 6, with total score ranging from 0 to 60 (higher MADRS scores indicate more severe depression). | The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had MADRS scores at Screening and EOT. | Posted | Mean | Standard Deviation | MADRS score | Screening and Day 36 |
|
|
|
|
| Secondary | Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score | The mean change in Q-LES-Q score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The Q-LES-Q is a self-report questionnaire rating 16 aspects of quality of life, including physical health and mood. Scores range from 0 ("very poor") to 5 ("very good"), with total score ranging from 0 to 80 (higher O-LES-Q scores indicate greater quality of life). | The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had Q-LES-Q scores at Screening and EOT. | Posted | Mean | Standard Deviation | Q-LES-Q Score | Screening and Day 36 |
|
|
|
|
| Secondary | Number of Participants Experiencing an Adverse Event (AE) | The number of participants experiencing one or more AEs throughout the study period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All treated participants are included in the safety analysis. | Posted | Number | Participants | Up to 59 days |
|
|
|
| Secondary | Number of Participants Discontinuing Study Therapy Due to AEs | The number of participants withdrawing from study treatment during the treatment period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All treated participants are included in the safety analysis. | Posted | Number | Participants | Up to 2 weeks |
|
|
|
| 0 |
| 11 |
| 8 |
| 11 |
| EG001 | Org 25935 12 mg | Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. | 0 | 15 | 12 | 15 |
| EG002 | Placebo | Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period. | 0 | 14 | 5 | 14 |
| Palpitations | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mydriasis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Visual brightness | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Feeling jittery | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Derealisation | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dissociation | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thinking abnormal | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
Not provided
Not provided
|
| Visit 4 - Screening (4 mg O n= 9; 12 mg O n=12) |
|
| Mean Difference (Final Values) |
| -0.4414 |
| 2-Sided |
| 95 |
| -3.5952 |
| 2.7124 |
| Superiority or Other |
|
| Follow-Up - Screening (12 mg O, Placebo n=12) |
|
| Mean Difference (Final Values) |
| 3.1317 |
| 2-Sided |
| 95 |
| -0.4518 |
| 6.7152 |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| PD w AGP: IPR |
|
| PD w/o AGP: Current |
|
| PD w/o AGP: IFR |
|
| PD w/o AGP: IPR |
|
|
| EOT - Screening (Placebo n=12) |
|
|
| EOT - Screening (12 mg O n=13; Placebo n=12) |
|
| Mean Difference (Final Values) |
| 2.0417 |
| 2-Sided |
| 95 |
| -2.5526 |
| 6.6360 |
| Superiority or Other |
|
| EOT - Screening (Placebo n=11) |
|
| Mean Difference (Final Values) |
| 2.0291 |
| 2-Sided |
| 95 |
| -7.2132 |
| 11.2714 |
| Superiority or Other |
|
| EOT - Screening (12 mg O n=13, Placebo n=12) |
|
| Mean Difference (Final Values) |
| 1.5260 |
| 2-Sided |
| 95 |
| -3.5495 |
| 6.6015 |
| Superiority or Other |
|
| EOT - Screening (12 mg O n=11, Placebo n=11) |
|
| Mean Difference (Final Values) |
| -6.1867 |
| 2-Sided |
| 95 |
| -11.5864 |
| -0.7869 |
| Superiority or Other |