Clinical Trials Register

Summary
EudraCT Number:	2009-017044-13
Sponsor's Protocol Code Number:	SPD476-409
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-05-06
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2009-017044-13

A.3

Full title of the trial

A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate
the Effect of Remission Status on the Ability to Maintain or Achieve
Clinical and Endoscopic Remission During a 12-Month, Long-term
Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine
Once Daily in Adult Subjects With Ulcerative Colitis

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis

A.3.2

Name or abbreviated title of the trial where available

MOMENTUM

A.4.1

Sponsor's protocol code number

SPD476-409

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Shire Development LLC
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Shire Development LLC
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Shire Pharmaceuticals Ltd
B.5.2	Functional name of contact point	Medical Communications
B.5.3	Address:
B.5.3.1	Street Address	Hampshire International Business Park
B.5.3.2	Town/ city	Chineham, Basingstoke
B.5.3.3	Post code	RG24 8EP
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	44 0800 0556614
B.5.5	Fax number	44 01256 894714
B.5.6	E-mail	medinfoglobal@shire.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Mezavant XL Gastro-resistant, prolonged release tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire Pharmaceutical Contracts Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Mezavant XL
D.3.2	Product code	SPD476
D.3.4	Pharmaceutical form	Gastro-resistant tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MESALAZINE
D.3.9.1	CAS number	89-57-6
D.3.9.2	Current sponsor code	SPD476
D.3.9.3	Other descriptive name	MMX Mesalamine/Mesalazine
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Ulcerative Colitis

E.1.1.1

Medical condition in easily understood language

Ulcerative and inflammation of the bowel

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10045365
E.1.2	Term	Ulcerative colitis
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to compare the percentage of subjects in complete (clinical and endoscopic) remission after 12 months of maintenance treatment with 2.4g/day MMX mesalamine/mesalazine given once daily (QD) between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment with 4.8g/day MMX mesalamine/mesalazine given QD.

E.2.2

Secondary objectives of the trial

1. To compare the percentage of subjects in clinical remission at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

2. To compare the time to relapse between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

3. To compare the percentage of subjects who achieve or maintain mucosal healing (endoscopy score ≤1) at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

4. To assess the improvement in symptoms at 3 and 8 weeks of acute treatment.

5. To assess the percentage of subjects who achieve complete remission at the end of 8 weeks acute treatment.

6. To assess the safety and tolerability of MMX mesalamine/mesalazine.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects meeting all of the criteria listed below at screening may be included in the study:

1. Adults aged 18 years or older.

2. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.

3. Diagnosis of active mild to moderate UC (acute flare or suspected newly diagnosed with a total score of 4‑10 inclusive on the modified UCDAI with an endoscopy score of ³1 and a PGA of ≤2).* The original diagnosis of UC must be established by sigmoidoscopy or colonoscopy and have compatible histology (performed prior to screening). An endoscopy with biopsies taken for confirmatory histology will be performed during the screening period for suspected newly diagnosed subjects only.

4. Stable maintenance therapy of 5-ASA ≤3.2g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare. Stable maintenance therapy is defined as no change in dose, or no initiation of 5-ASA, from the onset of the acute flare through baseline (Visit 0).

E.4

Principal exclusion criteria

Subjects are excluded from the study if any of the following criteria are met at screening:

1. Severe UC (assessed by PGA =3).*

2. Acute flare with onset >6 weeks prior to Baseline (Visit 0) while on maintenance
therapy. There is no limit to the onset of flare prior to Baseline (Visit 0) if the flare is
untreated.

3. Acute flare while on maintenance MMX mesalamine/mesalazine (LIALDA®, MEZAVANT®, MEZAVANT® XL,MEZAVANT® LP).

4. Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2g/day.

5. Acute flare on a 5-ASA maintenance therapy of >3.2g/day.

6. Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening.

7. History of biologic (anti-TNF agent) use.

8. Antibiotic use or repeated use (>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted.

9. Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the investigational medicinal product, or clinical or laboratory assessments.

* The symptom parameters of the modified UC-DAI (rectal bleeding and stool frequency) will be assessed at screening and Baseline (Visit 0). Endoscopy scores will be obtained at Baseline (Visit 0) to confirm eligibility, except in the case of suspected newly diagnosed subjects only, where endoscopy with biopsies taken for both confirmatory histology and for central laboratory assessment will be performed during the screening period. For all subjects (including suspected newly diagnosed subjects), the PGA, assessment of subject's symptoms, and calculation of total UC-DAI score will be performed at Baseline (Visit 0)

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is to compare the proportion of subjects in complete (clinical and endoscopic) remission after 12 months of maintenance treatment with 2.4g/day MMX mesalamine/mesalazine given QD between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment with 4.8g/day MMX mesalamine/mesalazine given QD.

Complete (clinical and endoscopic) remission is defined as a modified UC-DAI ≤1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in
endoscopy score from baseline (Visit 0).

Partial remission is defined as a modified UC-DAI ≤3 with a combined stool frequency and rectal bleeding score of ≤1 and not in complete remission.

E.5.1.1

Timepoint(s) of evaluation of this end point

29 December 2012

E.5.2

Secondary end point(s)

Efficacy
1. To compare the proportion of subjects in clinical remission (stool frequency and rectal bleeding scores equal to 0) at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

2. To compare the time to relapse (the need for alternative treatment for UC[including surgery]) between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

3. To compare the proportion of subjects who achieve or maintain mucosal healing (endoscopy score less than or equal to 1) at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

4. To assess the improvement in symptoms (rectal bleeding and stool frequency) from Baseline (Visit 0) to Weeks 3 and 8 weeks of acute treatment. Improvement is defined as at least a 1 point reduction in the symptom score from Baseline (Visit 0) to each assessment point.

5. To assess the proportion of subjects who achieve complete remission
at the end of 8 weeks acute treatment.

Safety
To assess the safety and tolerability of MMX mesalamine/mesalazine
throughout the study.

E.5.2.1

Timepoint(s) of evaluation of this end point

29 December 2012

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Colombia

India

Poland

Russian Federation

South Africa

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last visit of last subject undergoing treatment

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-05-06.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

225

F.4.2.2

In the whole clinical trial

1000

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

No Plans for treatment or care after the subject has ended participation in the trial.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-06-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-09-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-12-14

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