Trial · NCT02649751
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of increasing doses of Roscovitine | 3 months | The primary objective of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects who carrying 2 Cystic Fibrosis causing mutations with at least F508del mutation |
| Secondary | Change in the concentration of Pseudomonas Aeruginosa | 3 months | Change in the concentration (CFU/mL) of Pseudomonas aeruginosa in the sputum at each visit from V1 (Screening) up to V7 (Completion Visit). |
| Secondary | PK parameters | 3 months | PK parameters: Maximum Concentration (Cmax), Time to reach Cmax (Tmax), Area Under Curve (AUCt and AUCInf), Half-life (t1/2) for roscovitine and its M3 metabolite. |
| Secondary | Pro- and anti-inflammatory cytokines | 3 months | Monitoring the levels of pro- and anti-inflammatory cytokines, in particular: interleukin (IL)-17A, IL-5, IFN-γ, IL-1 receptor antagonist, IL-4, IL-6, IL-10, tumor necrosis factor-alpha, and IL-18 on V2, V3 and V7 (Completion Visit) |
| Secondary | C-reactive protein | 3 months | Change in C-reactive protein (CRP) at each visit from V1 (Screening) up to V7 (Completion) |
| Secondary | Cystic Fibrosis Questionnaire-Revised | 3 months | Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) at each visit from V1 up to V8 (Safety Follow-up) |
| Secondary | Body Mass Index | 3 months | Change in body mass index (BMI) at each visit from V1 (Screening) up to V7 (Completion Visit) |
| Secondary | Forced expiratory volume in 1 second | 3 months | Change in forced expiratory volume in 1 second (FEV1) at each visit from V1 (Screening) up to V7 (Completion Visit) |
| Secondary | Sweat Chloride Concentration | 3 months | Change in Sweat Chloride Concentration at V2, V3, V5 and V7 (Completion) |
| Secondary | Nasal Potential Difference | 3 months | Change in Nasal Potential Difference (NPD) at V1 (Screening) and V6 (for patients included in Paris Cochin CF Center) |
| Secondary | Pain questionnaire | 3 months | Evaluate of the pain and of the impact of the pain in patients with cystic fibrosis |
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/NCT02649751/registered