Clinical Trials Register

Summary
EudraCT Number:	2010-021367-32
Sponsor's Protocol Code Number:	P07515
National Competent Authority:	Ireland - HPRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-07-08
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

Ireland - HPRA

A.2

EudraCT number

2010-021367-32

A.3

Full title of the trial

A Randomized, Open-Label, Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation

A.3.2

Name or abbreviated title of the trial where available

N/A

A.4.1

Sponsor's protocol code number

P07515

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

N/A

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	Schering-Plough HealthCare Products, Inc
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Movicol® 13.8g sachet, powder for oral solution
D.2.1.1.2	Name of the Marketing Authorisation holder	Norgine Limited
D.2.1.2	Country which granted the Marketing Authorisation	Ireland
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.3.4	Pharmaceutical form	Powder for oral solution
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.3.9.1	CAS number	0
D.3.9.3	Other descriptive name	MACROGOL 3350
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	13.125
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	7647-14-5
D.3.9.3	Other descriptive name	SODIUM CHLORIDE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	350.7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	144-55-8
D.3.9.3	Other descriptive name	SODIUM BICARBONATE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	178.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	7447-40-7
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	46.6
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	Yes
D.3.11.13.1	Other medicinal product type	Polyethylene glycol 3350 plus electrolytes

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

Chronic constipation

MedDRA Classification

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 the study is to evaluate the proportion of subjects with a
bowel movement (BM) without straining or without hard and or lumpy stool within the first 24 hours of treatment for subjects taking one of three single doses of PEG+E (Movicol 13.8 g - 1, 2 or 3 sachets).

E.2.2

Secondary objectives of the trial

Secondary objectives will be measured by analysis of a subject diary and self-reported BM data. The secondary objectives include comparisons of PEG+E doses
at 24 hours for:

- bowel movement control;
- relief of gas;
- relief of bloating; and,
- relief of abdominal discomfort/cramping.

In addition, the proportion of subjects with a BM (without straining and without hard
and/or lumpy stool) within the first 24 hours of treatment for subjects taking different
doses of PEG+E will be evaluated for the time to first BM.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. A willingness to participate in the study and comply with its procedures.
2. Male or female.
3. Aged 18 years or older at the signing of the ICF on Visit 1.
4. Must be ambulatory.
5. Have stools less often than three times weekly and meet one or more of the following modified Rome III-based criteria for constipation:
a. Straining during all defecations
b. Lumpy or hard stools in at least 25% of defecations
c. Sensation of incomplete evacuation for at least 25% of defecations
d. Sensation of anorectal obstruction/blockage for at least 25% of defecations
e. Manual maneuvers to facilitate at least 25% of defecations (eg, digital evacuation, support of the pelvic floor)
6. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
7. Agrees not to use any treatment known to cause constipation during the course of the study, beginning at pre-study (Visit 1)
8. Agrees not to use laxatives other than the study treatment from baseline/informed consent (Visit 2) to end of study (Visit 4).
9. Agrees to maintain a similar diet from the week prior to randomization through end of study.
10. If a female subject, either surgically sterile, 2 years postmenopausal, or using an
acceptable method of contraception (including hormonal birth control, IUD,
double barrier methods, or vasectomized partner). Abstinence is not an
acceptable method of contraception. Females of childbearing potential must have
a urine pregnancy test (human chorionic gonadotropin [HCG]) that is negative at
Visit 3.
11. Be able to read and write in the diaries in English.

E.4

Principal exclusion criteria

1. Have loose stools without the use of laxatives.
2. Recurrent abdominal pain (if it is the predominant symptom of constipation).
3. Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
4. Celiac disease or known gluten sensitivity.
5. Known renal or hepatic insufficiency.
6. Recent history of alcohol abuse (in the Investigator’s opinion) or drug abuse.
7. History of psychiatric disorders. Currently clinically stable subjects (in the Investigator’s opinion) can be included.
8. History of significant (in the Investigator’s opinion) ongoing medical problems (including acute infections, renal or gastrointestinal disease) or who are scheduled for surgical procedures. All clinically significant medical of surgical conditions in the opinion of the investigator, abnormalities merit exclusion.
9. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
10. Participated in an investigational clinical, surgical, drug or device study within the past 30 days.
11. Pregnant or lactating.
12. Allergic to PEG or PEG + E.
13. Employed by or have immediate family members employed by a company that manufactures laxative products.
14. Subject or family member of the Investigator or site staff directly involved with this study.

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects with successful BM (i.e. BM with no straining or hard/lumpy stools) within 24 hours of dosing.

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

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

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

Yes

E.8.1.1

Randomised

Yes

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

Yes

E.8.2.3.1

Comparator description

1, 2 or 3 sachets of the IMP

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

The end of the trial is defined in the protocol as the last visit of the last subject.

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

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

175

F.4.2

For a multinational trial

F.4.2.1

In the EEA

175

F.4.2.2

In the whole clinical trial

175

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)

After the subject has complete the trial, the subject will be treated in accordance with the standard clinical practice for chronic constipation.

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

2010-08-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-07-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-11-23

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