NCT01966783

Brief Summary

The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 22, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

October 9, 2013

Last Update Submit

May 3, 2019

Conditions

Proctitis

Outcome Measures

Primary Outcomes (1)

  • Resolution of clinical symptoms

    Symptoms as reported in the diary

    8 weeks

Secondary Outcomes (4)

  • Rate of clinical and endoscopic remission

    8 weeks

  • Rate of improvement

    8 weeks

  • Rate of patients with clinical remission

    8 weeks

  • Rate of patients with endoscopic remission

    8 weeks

Study Arms (4)

Budesonide dosage 1

EXPERIMENTAL

Budesonide 2 mg suppository

Drug: Budesonide 2 mg suppository

Budesonide dosage 2

EXPERIMENTAL

Budesonide 4 mg suppository

Drug: Budesonide 4 mg suppository

Mesalazine

ACTIVE COMPARATOR

Mesalazine 1g suppository

Drug: Mesalazine 1 g suppository

Combination

EXPERIMENTAL

Budesonide 2 mg suppository/Mesalazine 1 g suppository

Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository

Interventions

Budesonide 2 mg suppositoryDRUG

per day

Budesonide dosage 1
Budesonide 4 mg suppositoryDRUG

per day

Budesonide dosage 2
Mesalazine 1 g suppositoryDRUG

per day

Mesalazine
Budesonide 2 mg suppository/Mesalazine 1 g suppositoryDRUG

per day

Combination

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active ulcerative proctitis
  • Diagnosis confirmed by endoscopy
  • Established disease or new diagnosis

You may not qualify if:

  • Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular assoc. colitis, microscopic colitis
  • Presence of proctitis of a different origin
  • Prior bowel resection
  • Presence of symptomatic organic disease of the gastrointestinal tract
  • Asthma, tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection if careful medical monitoring is not ensured
  • Local intestinal infection
  • Abnormal hepatic or renal function
  • Oral/rectal/intravenous corticosteroids therapy
  • Existing or intended pregnancy or breast-feeding
  • Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité-Campus Benjamin Franklin Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Evang. Krankenhaus Kalk, Medical Department

Cologne, 51103, Germany

Location

Related Publications (1)

  • Kruis W, Neshta V, Pesegova M, Alekseeva O, Andreev P, Datsenko O, Levchenko O, Abdulkhakov S, Lozynskyy Y, Mostovoy Y, Soloviev K, Dorofeyev AE, Vieth M, Stiess M, Greinwald R, Mohrbacher R, Siegmund B. Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):98-106.e4. doi: 10.1016/j.cgh.2018.04.027. Epub 2018 Apr 24.

    PMID: 29702300RESULT

MeSH Terms

Conditions

Proctitis

Interventions

BudesonideSuppositoriesMesalamine

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesRectal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDosage FormsPharmaceutical Preparationsmeta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Wolfgang Kruis, Professor

    Evang. Krankenhaus Kalk, Medical Department

    PRINCIPAL INVESTIGATOR

  • Britta Siegmund, Professor

    Charité-Campus Benjamin Franklin Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 22, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

DE(2)