NCT00808977

Brief Summary

The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach
4 countries

22 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

December 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 17, 2010

Status Verified

November 1, 2010

Enrollment Period

1.5 years

First QC Date

December 15, 2008

Last Update Submit

November 16, 2010

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal

    7, 14, 21, 28, 56 days

Secondary Outcomes (1)

  • Mayo index

    28 days

Study Arms (3)

Dersalazine

EXPERIMENTAL
Drug: Dersalazine sodium

Mesalazine

ACTIVE COMPARATOR
Drug: Mesalazine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Dersalazine sodiumDRUG

Dersalazine sodium 2400 mg daily

Dersalazine
MesalazineDRUG

Mesalazine 2400 mg daily

Mesalazine
PlaceboDRUG

Placebo matching active and experimental treatments

Placebo

Eligibility Criteria

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

You may qualify if:

  • Age 18 to 65 inclusive
  • Male, non-child-bearing female or fertile female with appropriate contraception.
  • Mild to moderate confirmed active ulcerative colitis
  • Able and willing to give informed consent

You may not qualify if:

  • Colitis of other cause
  • Pregnancy, inadequate contraception for fertile female patients
  • Liver or kidney disease, unstable cardiovascular disease, coagulation disorder.
  • Other significant medical condition that preclude participation at investigator criteria
  • Allergy or hypersensitivity to salicylates
  • Previous or concomitant treatment for ulcerative colitis interfering with safety or activity assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Investigational site 11

Kortrijk, Belgium

Location

Investigational site 1

Leuven, Belgium

Location

Investigational site 12

Budapest, Hungary

Location

Investigational site 10

Eger, Hungary

Location

Investigational site 9

Miskolc, Hungary

Location

Investigational site 8

Székesfehérvár, Hungary

Location

Investigational site 7

Vác, Hungary

Location

Investigational site 18

Košice, Slovakia

Location

Investigational site 20

Košice, Slovakia

Location

Investigational site 16

Malacky, Slovakia

Location

Investigational site 17

Nové Zámky, Slovakia

Location

Investigational site 19

Rožňava, Slovakia

Location

Investigational site 2

Badalona, Spain

Location

Investigational site 15

Barcelona, Spain

Location

Investigational site 3

Barcelona, Spain

Location

Investigational site 5

Barcelona, Spain

Location

Investigational site 21

Cadiz, Spain

Location

Investigational site 6

Córdoba, Spain

Location

Investigational site 22

Madrid, Spain

Location

Investigational site 14

Sabadell, Spain

Location

Investigational site 13

Terrassa, Spain

Location

Investigational site 4

Terrassa, Spain

Location

Related Publications (2)

  • Pontes C, Vives R, Torres F, Panes J. Safety and activity of dersalazine sodium in patients with mild-to-moderate active colitis: double-blind randomized proof of concept study. Inflamm Bowel Dis. 2014 Nov;20(11):2004-12. doi: 10.1097/MIB.0000000000000166.

    PMID: 25192498DERIVED

  • Roman J, Planell N, Lozano JJ, Aceituno M, Esteller M, Pontes C, Balsa D, Merlos M, Panes J, Salas A. Evaluation of responsive gene expression as a sensitive and specific biomarker in patients with ulcerative colitis. Inflamm Bowel Dis. 2013 Feb;19(2):221-9. doi: 10.1002/ibd.23020.

    PMID: 22605655DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

dersalazineMesalamine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Julian Panés, MD

    Hospital Clinic of Barcelona

    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

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 16, 2008

Study Start

December 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

November 17, 2010

Record last verified: 2010-11

Locations

BE(2)HU(5)SL(5)ES(10)