Trial · NCT03291080
Oral Liquid 13-cis-retinoic Acid (13-CRA)
NCT03291080, Phase 1, Phase 2, Completed, Nova Laboratories Limited; results first posted 2021-10-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Liquid 13-cis-retinoic Acid (13-CRA). Trials, record NCT03291080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03291080
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Liquid 13-cis-retinoic Acid (13-CRA)
- NCT number
- NCT03291080
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Nova Laboratories Limited
- Conditions
- Neuroblastoma
- Interventions
- Liquid 13-Cis Retinoic Acid, Extracted capsules 13-CRA
- First posted
- 2017-09-25
- Last updated
- 2021-10-19
- Results first posted
- 2021-10-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relative Bioavailability | On day 1 and 14 of treatment | Relative bioavailability (Area under the curve) of 13-CRA administered as oral liquid (test) and extracted capsule (reference) formulations. |
| Secondary | Maximum Plasma Concentration (Cmax) | On day 1 and 14 of treatment | Pharmacokinetic parameter for 13 CRA extracted capsules versus oral liquid formulation |
| Secondary | Time to Maximum Concentration (Tmax) | On day 1 and 14 of treatment | Pharmacokinetic parameter for 13 CRA extracted capsules versus oral liquid formulation |
| Secondary | Area Under Plasma Concentration Time Curve (AUC) Metabolite | On day 1 and 14 of treatment | Pharmacokinetic parameter for 13 CRA extracted capsules versus oral liquid formulation- metabolite 4-oxo-13-cisRA |
| Secondary | Cmax (ng/mL)- Metabolite | On day 1 and 14 of treatment | Pharmacokinetic parameter for metabolite 4-oxo-13-cisRA PK |
| Secondary | T Max of Metabolite | On day 1 and 14 of treatment | T max for metabolite -4-oxo-13-cisRA PK |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relative Bioavailability | On day 1 and 14 of treatment | Relative bioavailability - AUC (h.ng/mL) | (h.ng/mL) | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) | On day 1 and 14 of treatment | (ng/mL) | MEAN | |
| SECONDARY | Time to Maximum Concentration (Tmax) | On day 1 and 14 of treatment | (h) | MEAN | |
| SECONDARY | Area Under Plasma Concentration Time Curve (AUC) Metabolite | On day 1 and 14 of treatment | (h*ng/mL) | MEAN | |
| SECONDARY | Cmax (ng/mL)- Metabolite | On day 1 and 14 of treatment | (ng/mL) | MEAN | |
| SECONDARY | T Max of Metabolite | On day 1 and 14 of treatment | (h) | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relative Bioavailability | 13-CRA Oral Liquid | 10009.0 | Standard Deviation 3672.97 | (h.ng/mL) | |
| Relative Bioavailability | 13-CRA Extracted Capsule | 6075.9 | Standard Deviation 2090.66 | (h.ng/mL) | |
| Maximum Plasma Concentration (Cmax) | 13-CRA Oral Liquid | 1237.6 | Standard Deviation 662.67 | (ng/mL) | |
| Maximum Plasma Concentration (Cmax) | 13-CRA Extracted Capsule | 748.2 | Standard Deviation 379.28 | (ng/mL) | |
| Time to Maximum Concentration (Tmax) | 13-CRA Oral Liquid | 3.2 | Standard Deviation 0.76 | (h) | |
| Time to Maximum Concentration (Tmax) | 13-CRA Extracted Capsule | 3.0 | Standard Deviation 0.76 | (h) | |
| Area Under Plasma Concentration Time Curve (AUC) Metabolite | 13-CRA Oral Liquid | 38462.3 | Standard Deviation 18913.60 | (h*ng/mL) | |
| Area Under Plasma Concentration Time Curve (AUC) Metabolite | 13-CRA Extracted Capsule | 23312.7 | Standard Deviation 10947.59 | (h*ng/mL) | |
| Cmax (ng/mL)- Metabolite | 13-CRA Oral Liquid | 3366.2 | Standard Deviation 1648.08 | (ng/mL) | |
| Cmax (ng/mL)- Metabolite | 13-CRA Extracted Capsule | 2039.1 | Standard Deviation 952.23 | (ng/mL) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Cycle (2 Weeks) | STARTED | First Oral Liquid, Then Capsule | 11 | |
| First Cycle (2 Weeks) | STARTED | First Capsule, Then Oral Liquid | 9 | |
| First Cycle (2 Weeks) | COMPLETED | First Oral Liquid, Then Capsule | 11 | |
| First Cycle (2 Weeks) | COMPLETED | First Capsule, Then Oral Liquid | 9 | |
| First Cycle (2 Weeks) | NOT COMPLETED | First Oral Liquid, Then Capsule | 0 | |
| First Cycle (2 Weeks) | NOT COMPLETED | First Capsule, Then Oral Liquid | 0 | |
| Washout (2 Weeks) | STARTED | First Oral Liquid, Then Capsule | 11 | |
| Washout (2 Weeks) | STARTED | First Capsule, Then Oral Liquid | 9 | |
| Washout (2 Weeks) | COMPLETED | First Oral Liquid, Then Capsule | 11 | |
| Washout (2 Weeks) | COMPLETED | First Capsule, Then Oral Liquid | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Febrile neutropenia | Blood and lymphatic system disorders | 13-CRA Oral Liquid | 0 | 20 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | 13-CRA Extracted Capsule | 2 | 20 | 2 |
| other | Dry eye | Eye disorders | 13-CRA Oral Liquid | 3 | 20 | 3 |
| other | Dry eye | Eye disorders | 13-CRA Extracted Capsule | 2 | 20 | 2 |
| other | Chapped Lips | Gastrointestinal disorders | 13-CRA Oral Liquid | 8 | 20 | 9 |
| other | Chapped Lips | Gastrointestinal disorders | 13-CRA Extracted Capsule | 6 | 20 | 6 |
| other | Constipation | Gastrointestinal disorders | 13-CRA Oral Liquid | 3 | 20 | 4 |
| other | Constipation | Gastrointestinal disorders | 13-CRA Extracted Capsule | 3 | 20 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | 13-CRA Oral Liquid | 6 | 20 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | 13-CRA Extracted Capsule | 5 | 20 | 6 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 13-CRA Oral Liquid | 0 | 20 |
| Total, all-cause mortality | 13-CRA Extracted Capsule | 0 | 20 |
| Total, other adverse events | 13-CRA Oral Liquid | 18 | 20 |
| Total, other adverse events | 13-CRA Extracted Capsule | 15 | 20 |
| Total, serious adverse events | 13-CRA Oral Liquid | 10 | 20 |
| Total, serious adverse events | 13-CRA Extracted Capsule | 5 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33919763 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 13-CRA Oral Liquid vs 13-CRA Extracted Capsule: deaths from any cause | Trial comparisons |
| 13-CRA Oral Liquid vs 13-CRA Extracted Capsule: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03291080
GET https://conductscience.org/api/trials/v1/NCT03291080/events?page=2