PENTASA Sachet ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
96Crohn disease9
97Ulcerative colitis5

96. Crohn disease


Clinical trials : 2,400 Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00862121
(ClinicalTrials.gov)
April 200913/3/2009A Study With Pentasa in Patients With Active Crohn's DiseasePENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.Crohn´s DiseaseDrug: Pentasa;Drug: PlaceboFerring PharmaceuticalsNULLTerminated18 YearsN/AAll20Phase 3United States;Belgium;Denmark;France;Germany;Sweden;United Kingdom;Spain
2NCT00245505
(ClinicalTrials.gov)
February 200926/10/2005The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active Drug: Crohn's DiseaseThe Effect on Mucosal Healing With Pentasa Sachet 4g in Mild to Moderate Active Small Bowel Crohn´s Disease, Evaluated by Video Capsule Endoscopy After 6 and 12 Weeks Treatment. A Pilot StudyCrohn's DiseaseDrug: Mesalazine (Mesalamine)Ferring PharmaceuticalsNULLTerminated18 Years70 YearsBoth3Phase 3Sweden
3EUCTR2008-002100-26-BE
(EUCTR)
28/01/200931/07/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510France;Belgium;Denmark;Germany;United Kingdom;Sweden
4EUCTR2008-002100-26-FR
(EUCTR)
16/01/200902/09/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placeboPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Phase 3France;Belgium;Denmark;Germany;United Kingdom;Sweden
5EUCTR2008-002100-26-GB
(EUCTR)
07/01/200919/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Denmark;Belgium;France;Sweden
6EUCTR2008-002100-26-SE
(EUCTR)
27/11/200808/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Denmark;Belgium;France;Sweden
7EUCTR2008-002100-26-DE
(EUCTR)
19/11/200806/03/2009PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510France;Belgium;Denmark;Germany;United Kingdom;Sweden
8EUCTR2008-002100-26-DK
(EUCTR)
04/11/200818/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Belgium;Denmark;France;Sweden
9EUCTR2005-002472-15-SE
(EUCTR)
22/09/200523/06/2005The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A.The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A. Mild to moderate active Crohn's disease
MedDRA version: 7.1;Level: PT;Classification code 10011401
Trade Name: Pentasa Sachet 1 g prolonged release granules
Product Name: Pentasa Sachet 1 g
INN or Proposed INN: mesalazine
Other descriptive name: 5-Aminosalicylic acid
Ferring Laegemidler A/SNULLNot RecruitingFemale: yes
Male: yes
10Sweden

97. Ulcerative colitis


Clinical trials : 2,527 Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2004-004565-15-CZ
(EUCTR)
03/06/200513/04/2005Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUMPentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900
Trade Name: Pentasa sachet 1g
Product Name: Pentasa
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa prolonged release granules 2g
INN or Proposed INN: mesalazine
Ferring BVNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Finland;Denmark;Germany;Norway;Sweden
2EUCTR2004-004565-15-SE
(EUCTR)
24/05/200509/03/2005Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUMPentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900
Trade Name: Pentasa Sachet 1g
Product Name: Pentasa Sachet 1 g
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa Sachet 2 g
INN or Proposed INN: mesalazine
Ferring BVNULLNot RecruitingFemale: yes
Male: yes
360Finland;Germany;Czech Republic;Denmark;Norway;Sweden
3NCT00209300
(ClinicalTrials.gov)
May 200513/9/2005Pentasa Once Daily in Ulcerative Colitis for Maintenance of RemissionPentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once DailyUlcerative ColitisDrug: PentasaFerring PharmaceuticalsNULLCompleted18 YearsN/ABoth362Phase 3Belgium;Czech Republic;Denmark;Finland;Germany;Netherlands;Norway;Sweden
4EUCTR2004-004565-15-NO
(EUCTR)
06/04/200514/02/2005Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUMPentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900
Trade Name: Pentasa sachet 1g
Product Name: Pentasa
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Trade Name: NA
Product Name: Pentasa prolonged release granules 2g
INN or Proposed INN: mesalazine
Ferring BVNULLNot RecruitingFemale: yes
Male: yes
360Finland;Germany;Czech Republic;Denmark;Norway;Sweden
5EUCTR2004-004565-15-DK
(EUCTR)
31/03/200524/02/2005Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUMPentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900
Product Name: Pentasa Sachet
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa Sachet
INN or Proposed INN: mesalazine
Ferring BVNULLNot RecruitingFemale: yes
Male: yes
360Finland;Germany;Czech Republic;Denmark;Norway;Sweden