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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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 50 participants
Start Date 2004-12
Est. Completion 2005-09
Phase Phase 4

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT00302354

The ClinicalTrials.gov registry entry for NCT00302354 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 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 2 interventions - of which OROS methylphenidate HCl is the first listed.

NCT00302354 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.