deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02450890

Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

A Phase III, Multi-Center, Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Clinical Study to Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

Sponsor: Durect

Updated 8 times since 2017 Last updated: Nov 30, 2021 Started: Jun 30, 2015 Primary completion: Feb 28, 2017 Completion: Feb 28, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Attention Deficit Hyperactivity Disorder, this trial is completed. The trial is conducted by Durect and has accumulated 8 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshotActive Not Recruiting~Jan 2019 – ~Jan 2021 · 24 months · monthly snapshotUnknown Status~Jan 2021 – ~Jan 2022 · 12 months · monthly snapshotUnknown Status~Jan 2022 – ~Jul 2024 · 30 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2022 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Unknown StatusCompleted

  5. Jan 2021 — Jan 2022 [monthly]

    Unknown Status PHASE3

Show 3 earlier versions
  1. Jan 2019 — Jan 2021 [monthly]

    Unknown Status PHASE3

    Status: Active Not RecruitingUnknown Status

  2. Jun 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  3. Jan 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Jun 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Durect
  • Orient Pharma Co., Ltd.
Data source: Orient Pharma Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .