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NCT00302354 · ClinicalTrials.gov registry record · Phase 4
A Double-blind Randomized, Placebo-controlled, Crossover Study of Single Doses of OROS Methylphenidate Hydrochloride (CONCERTA) and Long-acting Methylphenidate Hydrochloride (RITALIN LA) in Healthy Adults
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT00302354: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00302354 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00302354, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is a double-blind, placebo-controlled study, three-period crossover study to examine the likeability of a single dose of OROS MPH (CONCERTAÒ 90mg) and a single dose of Long-acting MPH (RITALIN LAÒ 90mg). Hypotheses are as follows: Hypothesis 1: OROS-MPH (CONCERTAÒ) will be later than SODOS-MPH (RITALIN LAÒ) in its Tmax (time to Cmax). Hypothesis 2: The subjective feelings of detection and likeability would be greater for SODOS-MPH (RITALIN LAÒ) than for an equivalent total dose of OROS-MPH (CONCERTAÒ).
Interventions
- DRUG OROS methylphenidate HCl
- DRUG SODAS methylphenidate HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2004-12 |
| Est. Completion | 2005-09 |
| Phase | Phase 4 |
What the finished NCT00302354 record still lists
NCT00302354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which OROS methylphenidate HCl is the first listed.
NCT00302354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00302354 about?
NCT00302354 is a clinical study titled "A Double-blind Randomized, Placebo-controlled, Crossover Study of Single Doses of OROS Methylphenidate Hydrochloride (CONCERTA) and Long-acting Methylphenidate Hydrochloride (RITALIN LA) in Healthy Adults". This is a double-blind, placebo-controlled study, three-period crossover study to examine the likeability of a single dose of OROS MPH (CONCERTAÒ 90mg) and a single dose of Long-acting MPH (RITALIN LAÒ 90mg). Hypotheses are as follows: Hypothesis 1: OROS-MPH (CONCERTAÒ) will be later than SODOS-MPH...
What is the current status of trial NCT00302354?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2004-12. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00302354?
The interventions under investigation include: OROS methylphenidate HCl (DRUG), SODAS methylphenidate HCl (DRUG).
Who is sponsoring clinical trial NCT00302354?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00302354's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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