deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT02613494

Clozapine-induced Hypersalivation - Feasibility Trial (GOTHIC1)

A Feasibility Study of Glycopyrrolate in Comparison to Hyoscine Hydrobromide and Placebo in the Treatment of Hypersalivation Induced by Clozapine

Sponsor: Lancashire Care NHS Foundation Trust

Conditions Sialorrhea
Interventions Glycopyrrolate Hyoscine Placebo
Updated 7 times since 2017 Last updated: Feb 26, 2018 Started: Jan 25, 2016 Primary completion: Dec 31, 2017 Completion: Feb 23, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02613494, this PHASE1/PHASE2 trial focuses on Sialorrhea and remains completed. Sponsored by Lancashire Care NHS Foundation Trust, it has been updated 7 times since 2016, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2018 · 13 months · monthly snapshotNot Yet Recruiting~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshotUnknown Status~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  5. Mar 2018 — Jun 2018 [monthly]

    Completed PHASE1_PHASE2

    Status: Unknown Status → Completed

▶ Show 2 earlier versions

  1. Feb 2018 — Mar 2018 [monthly]

    Unknown Status PHASE1_PHASE2

    Status: Not Yet Recruiting → Unknown Status

  2. Jan 2017 — Feb 2018 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Jan 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Lancashire Care NHS Foundation Trust
  • Manchester Mental Health & Social Care Trust
  • Mersey Care NHS Trust
  • University of Central Lancashire
  • University of Manchester
Data source: Mersey Care NHS Trust

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

Study Locations