Trial · NCT00434213
Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
NCT00434213, Phase 4, Completed, Noven Therapeutics; results first posted 2009-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA. Trials, record NCT00434213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00434213
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
- NCT number
- NCT00434213
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 309 participants, actual
- Lead sponsor
- Noven Therapeutics
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Daytrana
- First posted
- 2007-02-13
- Last updated
- 2017-04-26
- Results first posted
- 2009-03-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dermal Reactions | 7 weeks | Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles. |
| Secondary | Contact Sensitization to Methylphenidate | 7 weeks | Contact sensitization to methylphenidate through skin patch testing. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dermal Reactions | 7 weeks | Safety population | Participants | NUMBER |
| SECONDARY | Contact Sensitization to Methylphenidate | 7 weeks | Safety population | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dermal Reactions | Daytrana | 0 (no evidence of irritation) | 46 | Participants | |
| Dermal Reactions | Daytrana | 1 (minimal erythema) | 97 | Participants | |
| Dermal Reactions | Daytrana | 2 (definite eythema) | 151 | Participants | |
| Dermal Reactions | Daytrana | 3 (erythema and papules) | 6 | Participants | |
| Dermal Reactions | Daytrana | 4 (definite edema) | 3 | Participants | |
| Dermal Reactions | Daytrana | 5 (erythema, edema, and papules) | 0 | Participants | |
| Dermal Reactions | Daytrana | 6 (vesicular eruption) | 0 | Participants | |
| Dermal Reactions | Daytrana | 7 (strong reaction beyond test site) | 0 | Participants | |
| Dermal Reactions | Daytrana | No dermal evaluation | 2 | Participants | |
| Contact Sensitization to Methylphenidate | Daytrana | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daytrana | 309 | |
| Overall Study | COMPLETED | Daytrana | 260 | |
| Overall Study | NOT COMPLETED | Daytrana | 49 |
Source ClinicalTrials.gov
Adverse events8
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 | Decreased appetite | Metabolism and nutrition disorders | Daytrana | 95 | 305 | 99 |
| other | Headache | Nervous system disorders | Daytrana | 50 | 305 | 64 |
| other | Insomnia | Psychiatric disorders | Daytrana | 32 | 305 | 34 |
| other | Abdominal pain upper | Gastrointestinal disorders | Daytrana | 26 | 305 | 36 |
| other | Affect lability | Psychiatric disorders | Daytrana | 22 | 305 | 26 |
| other | Nausea | Gastrointestinal disorders | Daytrana | 22 | 305 | 27 |
| other | Upper respiratory tract infection | Infections and infestations | Daytrana | 20 | 305 | 20 |
| other | Irritability | Psychiatric disorders | Daytrana | 18 | 305 | 18 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daytrana | ||
| Total, other adverse events | Daytrana | 242 | 305 |
| Total, serious adverse events | Daytrana | 0 | 305 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21494336 | RESULT |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00434213
GET https://conductscience.org/api/trials/v1/NCT00434213/registered