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NCT00303602 · ClinicalTrials.gov registry record · Phase 4

Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)

A Phase 4 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 4
Development phase
149
Enrollment target

NCT00303602: Completed Phase 4 study, sponsored by Eli Lilly and Company.

NCT00303602 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 149 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00303602, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 4
Development phase
149 participants
Enrollment target

Study Summary

This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in patients who are already gaining weight on olanzapine.

Primary Outcome

Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.

Interventions

  • DRUG Sublingual orally disintegrating olanzapine (SODO)
  • DRUG Oral olanzapine

Trial Details

FieldValue
Enrollment Target 149 participants
Start Date 2006-03
Est. Completion 2007-12
Phase Phase 4
Eli Lilly and Company

1,341 total trials

What the finished NCT00303602 record still lists

NCT00303602 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 2 interventions - of which Sublingual orally disintegrating olanzapine (SODO) is the first listed.

NCT00303602 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00303602 about?

NCT00303602 is a clinical study titled "Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)". This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in patients who are already gaining weight on olanzapine.

What is the current status of trial NCT00303602?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 149 participants. The study started on 2006-03. Estimated completion is 2007-12.

What interventions are being tested in trial NCT00303602?

The interventions under investigation include: Sublingual orally disintegrating olanzapine (SODO) (DRUG), Oral olanzapine (DRUG).

Who is sponsoring clinical trial NCT00303602?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00303602's enrollment target sits among peer trials

149 565th of 2000 higher than 1,434 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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Source: ClinicalTrials.gov NCT00303602, the US trial registry maintained by the National Library of Medicine. NCT00303602 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.