Trial · NCT01829321
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of adverse events | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of the number of adverse events reported |
| Primary | Changes in physical exam measures | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of the changes in physical exam measures reported |
| Primary | Changes in vital signs as measured by heart rate, blood pressure and oral temperature | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of the changes in vital signs as measured by heart rate, blood pressure and oral temperature reported |
| Primary | Changes in 12-lead ECG measures | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of the changes in 12-lead ECG measures reported |
| Primary | Changes in blood safety lab parameters | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of changes in blood safety lab parameters reported |
| Primary | Changes in urine safety lab parameters | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of changes in urine safety lab parameters reported |
| Secondary | Changes in (partial) Mayo clinical disease activity score | From Day 1 to Day 29 | To evaluate the efficacy of GLPG0974 in terms of changes in (partial) Mayo clinical disease activity score reported |
| Secondary | Changes in histopathological clinical activity score in colon biopsies | Day 1 and Day 29 | To evaluate the efficacy of GLPG0974 in terms of changes in histopathological clinical activity score (Geboes score) in colon biopsies reported |
| Secondary | The amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 | Day 8, Day 15 and Day 29 | To evaluate the amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 - pharmacokinetics (PK) in ulcerative colitis patients |
| Secondary | Changes in the levels of faecal calprotectin over time after multiple oral doses of GLPG0974 | Screening up to Day 29 | To evaluate the changes in the levels of calprotectin in faeces over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients |
| Secondary | Changes in the levels of C-reactive protein in serum over time after multiple oral doses of GLPG0974 | Screening up to Day 29 | To evaluate the changes in the levels of C-reactive protein in serum over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients |
| Secondary | Changes in the levels of myeloperoxidase (MPO) in colon biopsies over time after multiple oral doses of GLPG0974 | Day 1 and Day 29 | To evaluate the changes in the levels of MPO in colon biopsies over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients |
| Secondary | Changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974 | Day 1 and Day 29 | To evaluate the changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients |
| Secondary | Changes in the levels of predominant microbiota in colon biopsies over time after multiple oral doses of GLPG0974 | Day 1 and Day 29 | To evaluate the changes in the levels of predominant microbiota in colon biopsies over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients |
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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GET https://conductscience.org/api/trials/v1/NCT01829321/registered