Trial · NCT03500159
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean) | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the maximum daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary) |
| Secondary | Change From Baseline to Week 12 in NIH-CPSI | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) pain subscale and all domains total score |
| Secondary | Change From Baseline to Week 12 in IIEF-EF | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in Male sexual health as measured using the International Index of Erectile Function Questionnaire, Erectile Function Domain (IIEF-EF) |
| Secondary | Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary), | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the average daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary) |
| Secondary | Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the average and maximum pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded on paper-based questionnaire at clinic visits. |
| Secondary | Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary) | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in voiding frequency as recorded by electronic diary (eDiary) |
| Secondary | Time Course of Effects From Baseline Through to Week 16: AQX-1125 200 mg Compared to Placebo for Each of the Pain and Symptom Scale Endpoints | 16 Weeks | Change from Baseline at each clinic visit for AQX-1125 200 mg compared to placebo for; Mean of maximum daily pelvic pain score (eDiary), NIH-CPSI pain subscale and all domains total score, IIEF-EF, Mean of average daily pelvic pain scores (eDiary), average and maximum pelvic pain (Paper-based NRS in clinic), and 24-hour voiding frequency (eDiary) |
| Secondary | Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA | 12 Weeks | AQX-1125 200 mg compared to placebo as measured by the Global Response Assessment (GRA) at Week 12 |
| Secondary | Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C | 12 Weeks | AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Change Scale (PGI-C) at Week 12 |
| Secondary | Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S | 12 Weeks | AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Severity Scale (PGI-S) at Week 12 |
| Secondary | The Proportion of Subjects With ≥30% and ≥50% Improvement in Maximum Daily Pelvic Pain Compared to Placebo | 12 Weeks | Comparison between AQX-1125 200 mg and placebo in proportion of subjects with ≥30% and ≥50% improvement in maximum daily pelvic pain (mean) based on a standardized 11-point numeric rating scale (NRS) recorded by eDiary at Week 6 and 12 |
| Secondary | The Proportion of Subjects With ≥30% and ≥50% Improvement in NIH-CPSI Pain Subscale Compared to Placebo | 12 Weeks | Comparison between AQX-1125 200 mg and placebo in proportion of subjects with ≥30% and ≥50% improvement NIH-CPSI subscale at Week 6 and 12 |
| Secondary | Response to Treatment | 12 Weeks | Response to treatment as defined by a decrease in maximum daily pelvic pain (eDiary) at Week 12 with a decrease or no change to concomitant analgesic medication use. |
| Secondary | Discontinuation of Study Medication Due to Treatment Failure | 12 Weeks | |
| Secondary | Frequency and Severity of Adverse Events (AEs) | 12 Weeks |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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