Trial · NCT04043455
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12 | Baseline and Week 12 | Main Study Full Analysis Set. Only those participants with data available at the specified timepoints were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 14 Weeks | Main Study Safety Set comprises of participants randomly assigned to study treatment and who took at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | LTE Period: Number of Participants With TEAEs and SAEs | Up to 54 Weeks | LTE Period Safety Set comprises of participants randomly assigned to study treatment and who took at least one dose of study treatment in the LTE Period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Main Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters | Baseline to Week 14 | Main Study Safety Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters | Baseline to Week 54 (of LTE) | LTE Safety Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Main Study: Number of Participants With Clinically Significant Abnormal Vital Signs | Baseline to Week 14 | Main Study Safety Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs | Baseline to Week 54 (of LTE) | LTE Safety Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at Week 12 | Baseline and Week 12 | Main Study Full Analysis Set. | Percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving a >= 30% Improvement in AAPS From Baseline for at Least 6 of the 12 Weeks | Baseline and Week 12 | Main Study Full Analysis Set. | Percentage of participants | NUMBER |
| SECONDARY | Main Study: Percent Change From Baseline in AAPS at Week 12 | Baseline and Week 12 | Main Study Full Analysis Set. Only those participants with data available at the specified timepoints were analyzed. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Main Study: Change From Baseline in Number of Pain-Free Days at Week 12 | Baseline and Week 12 | Main Study Full Analysis Set. Only those participants with data available at the specified timepoints were analyzed. | Days per week | LEAST_SQUARES_MEAN |
| SECONDARY | Main Study: Maximum Concentration (Cmax) of Olorinab | On Day 1: Pre-dose and 0.5, 1, 2, 4, and 8 hours post dose and Week 4: Pre-dose and 0.5, 1 and 2 hours post dose | Main Study PK Analysis Set comprises of all participants in the Full Analysis Set with at least one post-dose PK parameter. Only those participants with data available at the specified timepoints were analyzed. | Nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Main Study: Time of Maximum Concentration After Drug Administration (Tmax) of Olorinab | On Day 1: Pre-dose and 0.5, 1, 2, 4, and 8 hours post dose and Week 4: Pre-dose and 0.5, 1 and 2 hours post dose | Main Study PK Analysis Set. Only those participants with data available at the specified timepoints were analyzed. Sampling times reflected timeframe based on actual time and not planned nominal time. | Hours | MEDIAN |
| SECONDARY | Main Study: Plasma Trough Concentrations (Ctrough) of Olorinab | Pre dose on Day 1, Day 2 and Weeks 2, 4, 8, 10 and 12 | Main Study PK Analysis Set. Only those participants with data available at the specified timepoints were analyzed. | ng/mL | GEOMETRIC_MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04043455/outcomes