Comparison · NCT04754802-016bb1a9
PH94B vs Placebo: Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. PH94B vs Placebo: Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment). Trial comparisons, record NCT04754802-016bb1a9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04754802-016bb1a9
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.306 | 0.228 | 0.397 | wilson | |
| Risk in group 2 | 0.321 | 0.242 | 0.413 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0151 | -0.135 | 0.106 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.953 | 0.646 | 1.41 | log | |
| Odds ratio, group 1 over group 2 | 0.932 | 0.529 | 1.64 | log | |
| Number needed to treat, for one fewer participant with the outcome on PH94B than on Placebo | 66.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PH94B | 3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time~PH94B Nasal Spray: Nasal spray delivered 20 minutes before the public speaking stressor | 34 | 111 | OG000 |
| Group 2 | Placebo | Placebo intranasal spray (100 microliters to each nostril) one time~Placebo Nasal Spray: Nasal spray delivered 20 minutes before the public speaking stressor | 36 | 112 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment)
- Description
The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item scored from 1 (Very much less anxious) to 7 (Very much more anxious) with 4 being no change. Subjects are considered CGI-I responders with scores of 1 (Very much less anxious) or 2 (Much less anxious
- Time frame
- Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)
- Population
- Although the population of analysis included n=112, one subject had no CGI-I value. No imputation was done for secondary endpoints, resulting in n=111 in the denominator.
Source ClinicalTrials.gov
Trial
- Title
- PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
- NCT number
- NCT04754802
- Phases
- PHASE3
- Conditions
- Social Anxiety Disorder
- Interventions
- PH94B Nasal Spray, Placebo Nasal Spray
- Lead sponsor
- VistaGen Therapeutics, Inc.
- Results first posted
- 2025-09-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04754802?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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