Trial · NCT02820519
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Loxapine dosage with the lowest incidence of events. | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | The primary endpoint is defined as the first occurrence of a (serious) adverse event ((S)AE) leading to dose reduction or withdrawal of loxapine ("event"). The loxapine dosage with the lowest incidence of events will be identified. |
| Secondary | Number, type, and severity of (serious) adverse events ((S)AEs) | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Number, type, and severity of (serious) adverse events ((S)AEs) |
| Secondary | Cumulative incidence rates for (S)AE pattern of study participants | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Cumulative incidence rates for (S)AE pattern of study participants |
| Secondary | Individual (study participant-related) incidence of individual (S)AEs | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Individual (study participant-related) incidence of individual (S)AEs |
| Secondary | Individual (study participant-related) changes in pain severity (NRS scale) | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Individual (study participant-related) changes in pain severity (measured by using 11-point numeric pain rating scale) in relation to treatment phase and loxapine dosage |
| Secondary | Association between event pattern and individual pain level (NRS scale) | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Assessment of the association between the pattern of events (Primary endpoint) related to the individual pain level (clinically relevant pain reduction is defined by an at least 30% decrease or an absolute decrease of two scale units compared to baseline using 11-point numeric pain rating scale. |
| Secondary | Individual (study participant-related) changes in pain severity (painDETECT) | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Individual (study participant-related) changes in pain severity (measured by painDETECT questionnaire) in relation to treatment phase and loxapine dosage |
| Secondary | Association between event pattern and individual pain level (painDETECT) | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Assessment of the association between the pattern of events (Primary endpoint) related to the individual changes in pain severity / characteristics measured by painDETECT questionnaire |
| Secondary | Individual (study participant-related) changes in QoL (SF-12v2) | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Individual (study participant-related) changes in the quality of life (12-item Short Form Health Survey (SF-12v2)) in relation to treatment phase and loxapine dosage |
| Secondary | Association between event pattern and QoL (SF-12v2) | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Assessment of the association between the pattern of events (Primary endpoint) related to the individual quality of life changes changes (12-item Short Form Health Survey (SF-12v2)) |
| Secondary | Individual (study participant-related) changes in anxiety and depression (HADS-D scale) | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Individual (study participant-related) changes in anxiety and depression (HADS-D scale) in relation to treatment phase and loxapine dosage |
| Secondary | Association between event pattern and anxiety and depression (HADS-D scale) | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Assessment of the association between the pattern of events (Primary endpoint) related to the individual changes in anxiety and depression (HADS-D scale) |
| Secondary | Association between event pattern and analgesic co-medication | After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57) | Assessment of the association between the pattern of events (Primary endpoint) related to the individual changes in analgesic co-medication |
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
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