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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00302458
The ClinicalTrials.gov registry entry for NCT00302458 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00302458 reports 0 study locations.
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.
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