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NCT00302458 · ClinicalTrials.gov registry record · Phase 4
A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT00302458: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00302458 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00302458, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a double-blind, randomized, placebo-controlled, five-period crossover study to examine the likability of a repeated administration of immediate release methylphenidate hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses are as follows: * Hypothesis 1: the subjective feelings of detection and likeability will be greater for periods of IR-MPH administration than after OROS-MPH administration irregardless of sequence; * Hypothesis 2: the greater ratings of feelings of detection and likeability will be associated with the periods of most rapid change in plasma d-MPH and not with the magnitude of plasma d-MPH concentration (other than the OROS-MPH to IR-MPH condition in which they coincide), and * Hypothesis 3: the subjective feelings of dislike will be greatest for the two conditions in which IR-MPH is the second condition.
Primary Outcome
Objective measure determined from blood samples, measured 4 hours after the dose
Interventions
- DRUG Placebo
- DRUG OROS-Methylphenidate
- DRUG Immediate Release Methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-06 |
| Phase | Phase 4 |
What the finished NCT00302458 record still lists
NCT00302458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00302458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00302458 about?
NCT00302458 is a clinical study titled "A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults". This is a double-blind, randomized, placebo-controlled, five-period crossover study to examine the likability of a repeated administration of immediate release methylphenidate hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses are as follows: * Hypothesis 1: ...
What is the current status of trial NCT00302458?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2006-01. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00302458?
The interventions under investigation include: Placebo (DRUG), OROS-Methylphenidate (DRUG), Immediate Release Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT00302458?
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 NCT00302458's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 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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