deltatrials
Terminated PHASE2 INTERVENTIONAL 2-arm NCT00828230

Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Randomised, Double-blind, Placebo-controlled, Multicentre, Comparative Phase II Pilot Study on the Efficacy and Tolerability of an 8-week Rectal Treatment With 2 mg Budesonide or Placebo for the Prevention of Acute Radiation Proctitis

Sponsor: Dr. Falk Pharma GmbH

Conditions Radiation Proctitis
Interventions Placebo foam budesonide
Updated 9 times since 2017 Last updated: Jan 26, 2012 Started: Sep 30, 2008 Primary completion: Aug 31, 2011 Completion: Oct 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study was prematurely stopped due to slow recruitment after 17 of 32 anticipated patients were recruited.

Other terminated trials from Dr. Falk Pharma GmbH

More terminations from Dr. Falk Pharma GmbH

Listed as NCT00828230, this PHASE2 trial focuses on Radiation Proctitis and remains terminated or withdrawn. Sponsored by Dr. Falk Pharma GmbH, it has been updated 9 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

9 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE2

  5. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE2

▶ Show 4 earlier versions

  1. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE2

  2. May 2018 — Jun 2018 [monthly]

    Terminated PHASE2

  3. Aug 2017 — May 2018 [monthly]

    Terminated PHASE2

  4. Jan 2017 — Aug 2017 [monthly]

    Terminated PHASE2

    First recorded

Sep 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Dr. Falk Pharma GmbH
Data source: Dr. Falk Pharma GmbH

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

Study Locations