ConstipationPhase 4NCT00276354
Study of Long-term Use of Forlax® in Elderly Patients With Chronic Constipation
A Phase 4 study testing PEG 4000 (Forlax ®) in people with Constipation, run by Ipsen at 146 sites in France.
Trial summary
The main purpose of this study is to evaluate the tolerance of long term repeated doses of Forlax® 10g versus lactulose in elderly ambulatory or institutionalized patients, paying special attention to digestive and nutritional status. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- PEG 4000 (Forlax ®)
- How many people
- 246 participants
- Where
- 146 sitesFrance
- Study dates
- Dec 1999to 20 Nov 2001
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Institutionalized patients (in a medical care ward) for at least 3 months, or ambulatory patients
- Suffering from chronic constipation defined as:
- either less than 3 stools per week for at least 3 months and no or partial efficacy of dietary advices, OR
- patient treated with laxative medication/s for at least 3 months before inclusion, because of chronic constipation corresponding to less than 3 stools per week in case of no laxative treatment
- patient has less than 3 stools during 7 consecutive days of the screening wash-out period
Who cannot join
- known organic intestinal disease
- having had intestinal surgery
- abdominal or pelvic radiation, carcinoma, obstructive disease, malabsorption disease
- fecal mass in the rectum which cannot be completely evacuated during the screening wash-out period
Trial locations and contacts
146 sites in 1 country.
146 sites in 1 country
France146 sites
19 rue Jules Guesde
Abscon, 59215
Centre Saint Victor
Amiens, 80054
117 ter rue Jean Jaurès
Anzin, 59410
8 rue Jean Jaurès
Anzin, 59410
26 av. Charles de Gaulle
Aubevoye, 27940
89 avenue de Niort
Beauvoir-sur-Niort, 79360
11 Place de la République
Blois, 41000
39, avenue de France
Blois, 41000
30 rue Bayeux
Bretteville-l'Orgueilleuse, 14740
30 rue Pasteur
Bruille-lez-Marchiennes, 59490
6 avenue du 6 Juin
Caen, 14000
98 Boulevard du Maréchal Lyautey
Caen, 14000
Rue de l'Hôtel de Ville
Carquefou, 44470
La Cerisaie
Castelmaurou, 31180
33 rue Gambetta
Château-Renault, 37110
94 bis bld de la République
Châtelaillon-Plage, 17340
25 avenue de Nantes
Cholet, 49300
116 rue Henri Barbusse
Denain, 59220
25 Place Gambetta
Denain, 59220
6 rue de Ronde
Derval, 44590
CHS de la Chartreuse
Dijon, 21000
10 rue du Soleil Couchant
Dompierre-sur-Mer, 17139
19, avenue de la Gare
Droué, 41270
5 route de Paris
Écouis, 27440
1 rue du Jardin Botanique
Évreux, 27000
6 Centre Commercial les Peupliers
Évreux, 27000
8 bis rue du Bout du Pont
Faverolles-sur-Cher, 41400
9 rue Cure
Fenioux, 79160
15 rue Taffin
Fresnes-sur-Escaut, 59970
95 rue Jean-Jaurès
Fresnes-sur-Escaut, 59970
14 av. Aristide Briand
Gravigny, 27930
CHU Grenoble
Grenoble, 38043
Hôpital Charles Foix
Ivry-sur-Seine, 94205
Résidence, Grand Maison
L'Union, 31240
13 rue Balletant
La Ferté-Imbault, 41300
62 rue de Lattre
La Forêt-sur-Sèvre, 79380
121 rue M. Delage
La Garde, 83130
8 Chemin des Vendéens
La Jubaudière, 49510
11 place Sainte Anne
La Riche, 37520
194 rue Marius Lacroix
La Rochelle, 17000
28 rue du Paradis
La Séguinière, 49280
215 route de Bretagne
La Verenne, 44270
1, rue de l'Egalité
Lamotte-Beuvron, 41600
7 rue de Bel Air
Le Cellier, 44850
60 rue de la République
Le Neubourg, 27110
Hôpital Saint Julien
Le Petit-Quevilly, 76140
Hôpital Saint-Julien
Le Petit-Quevilly, 76140
21 Avenue Gabriel Péri
Le Pradet, 83220
360 Avenue de la 1ère DFL
Le Pradet, 83220
360, avenue de la 1ère DFL
Le Pradet, 83220
390 av. de la lère DFL
Le Pradet, 83220
46 Place Paul Flamenq
Le Pradet, 83220
61 avenue de la lère DFL
Le Pradet, 83220
13 rue de la Libération
Les Andelys, 27700
Maison de Retrate Saint-Jean
Lille, 59000
57 rue Dupont de l'Eure
Louviers, 27400
9 rue du Chatel
Louviers, 27400
Bd Clémenceau
Louviers, 27400
8 rue Saint Venant
Luynes, 37230
1 rue Pavée
Mainneville, 27150
Centre de Gérontologie, Yvon Lamour
Maniquerville, 76400
4 rue de Champagne
Marly, 59770
10 rue des Vignes
Ménigoute, 79340
94 rue Henri Urbain
Mortagne-du-Nord, 59158
25 rue V. Désormeaux
Mûrs-Erigné, 49610
181 rue Paul Bellamy
Nantes, 44000
101 Boulevard de Doulon
Nantes, 44300
63 rue de la Bottière
Nantes, 44300
13 av. de la République
Niort, 79000
189 Avenue de la Rochelle
Niort, 79000
277 av. de la Rochelle
Niort, 79000
6 pl. de la Comédie
Niort, 79000
24 rue de la Poste
Niort-Souche, 79000
30 Boulevard de la Gare
Nort-sur-Erdre, 44390
12 place d'Armes
Nueil-sur-Layon, 49560
26 Place Pasteur
Onnaing, 59624
76 rue des Ormeaux
Oudon, 44521
16 rue Aristide Briand
Pacy-sur-Eure, 27120
Hôpital Pitié Salpétrière
Paris, 75561
14 rue de Valencay
Périgny, 17180
14 rue de Valençay
Périgny, 17180
Centre Hospitalier Sud Hôpital Xavier Arnozan
Pessac, 33604
3 Rue Nouvelle
Pierrefitte-sur-Sauldre, 41300
29 rue Blin
Pont-de-l'Arche, 27340
35 bis rue du Général de Gaulle
Pont-de-l'Arche, 27340
28 bis route de Niort
Prahecq, 79230
7 rue Gambetta
Quarouble, 59243
271 rue Henri Durre
Raismes, 59590
338 rue Henri Durre
Raismes, 59590
Hôpital Boisguillaume - CHU de Rouen
Rouen, 76031
Hôpital Charles Nicolle - Service de Biochimie Médicale
Rouen, 76031
Hôpital Charles Nicolle - Service de Gastroentérologie et Nutrition
Rouen, 76031
Centre Hospitalier
Saint-Amand-les-Eaux, 59230
30 av. du Gl. de Gaulle
Saint-Avertin, 37550
Centre de Long Séjour
Saint-Chamond, 42400
Centre Hospitalier St Chamond
Saint-Chamond, 42400
5 rue Saint Nicolas
Saint-Germain-de-Marencennes, 17700
1 rue Vanneau
Saint-Jean-de-Liversay, 17170
Hôpital de Saint Jean de luz
Saint-Jean-de-Luz, 64500
34 rue du Poirier
Saint-Macaire-en-Mauges, 49450
53 bld du 8 Mai 1945
Saint-Macaire-en-Mauges, 49450
Les jardins de Rambam
Saint-Orens-de-Gameville, 31650
Maison de retraite
Saint-Orens-de-Gameville, 31650
36 Rue Louise Michel
Saint-Ouen, 41100
Chemin Vert
Saint-Pierre-des-Échaubrognes, 79700
Rue du Petit Montrevault
Saint-Pierre-Montlimart, 49110
Chemin de la Choisière
Saint-Rémy-en-Mauges, 49110
27 rue Principale
Saint-Romain-sur-Cher, 41140
12, rue Jean Cocteau
Saint-Saulve, 59880
1 Allée Jean Restout
Saint-Sébastien-de-Morsent, 27180
19 rue de la Mairie
Saint-Vincent-des-Landes, 44590
116 bis rue du 14 Juillet
Sainte-Marie-de-Ré, 17740
31 bis rue de la République
Sainte-Marie-de-Ré, 17740
Les Vergers du Château
Solliès-Pont, 83210
31 bis rue de la République
Ste Marie En Ré, 17740
28 rue Roger Salengro
Thiant, 59224
18 rue de la Baronne
Thilouze, 37260
1 rue de Bayeux
Tilly-sur-Seulles, 14250
121 av. de la Résistance
Toulon, 83000
148 Avenue Cuzin
Toulon, 83000
355 Avenue Claret
Toulon, 83000
535 av. de la Résistance
Toulon, 83000
6 bld Noble le Piermone
Toulon, 83000
641 rue Sainte Claire Deville
Toulon, 83000
641 rue Sainte Deville
Toulon, 83000
15 rue Gimelli
Toulon, 83100
112 Avenue du Xvème corps
Toulon, 83200
2 pl. Martin Bidouré
Toulon, 83200
4 pl. Jean Macé
Toulon, 83200
Capitole Santé
Toulouse, 31000
Hostellerie Languedocienne
Toulouse, 31000
Hôpital de la Grave-Casse Lardit
Toulouse, 31052
Résidence St Simon
Toulouse, 31500
3 rue Maryse Bastié
Tours, 37000
81 rue Blaise Pascal
Tours, 37000
13 rue Ernest Huard
Tours, 37100
Centre de Gériatrie du Comte Henry
Troyes, 10000
Centre Hospitalier de Troyes
Troyes, 10000
9 rue Beaurepaire
Valanjou, 49670
16 rue Anatole France
Valenciennes, 59300
Résidence Saly - 2 rue S. Lebourg
Valenciennes, 59300
200 rue Jean Jaurès
Vieux-Condé, 59690
4 rue Beaurepaire
Vihiers, 49310
Hôpital Paul Brousse
Villejuif, 94804
4, Place Jules Verne
Vineuil, 41350
85 rue Jean Jaurès
Wallers, 59135
About this study
Official title: Tolerance of Long Term Administration of Forlax® 10g in Elderly Ambulatory or Institutionalized Patients Suffering From Chronic Constipation. Single Blind Randomised Lactulose-controlled Study With Individual Expected Benefit.
The main purpose of this study is to evaluate the tolerance of long term repeated doses of Forlax® 10g versus lactulose in elderly ambulatory or institutionalized patients, paying special attention to digestive and nutritional status.
- Conditions
- Constipation
- Being tested
- PEG 4000 (Forlax ®)
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG 4000 (Forlax ®)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and biological tolerance with special attention to digestive and nutritional status. Clinical tolerance will be assessed by digestive symptomatology collected on a daily basis
Digestive examination assessed at screening wash-out period and each month
Nutritional status assessed at screening wash-out period, month 3 and month 6
Vital signs assessed at screening wash-out period, month 3 and month 6. Biological tolerance will be assessed by nutritional markers, malabsorption markers and routine laboratory tests assessed at screening wash-out period and month 3 and 6.
Drug interaction assessment assessed at screening wash-out period and month 3 and 6.
Secondary outcomes (2)
Long term efficacy based on daily nurse diary
Healthcare cost analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startDec 1999
- Study completion20 Nov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276354
- Sponsor's protocol ID
- 2-31-52072-003
- Status last verified
- Jul 2019
- First submitted
- 12 Jan 2006
- Last updated
- 26 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Long Term Administration of Forlax® 10g in Elderly Ambulatory or Institutionalized Patients Suffering From Chronic Constipation. Single Blind Randomised Lactulose-controlled Study With Individual Expected Benefit.
- ClinicalTrials.gov ID
- NCT00276354
- Acronym / sponsor ID
- 2-31-52072-003
- Conditions
- Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Dec 1999
- Study completion
- 20 Nov 2001 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the tolerance of long term repeated doses of Forlax® 10g versus lactulose in elderly ambulatory or institutionalized patients, paying special attention to digestive and nutritional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Institutionalized patients (in a medical care ward) for at least 3 months, or ambulatory patients
- Suffering from chronic constipation defined as:
- patient has less than 3 stools during 7 consecutive days of the screening wash-out period
Key exclusion criteria (4 listed)
- known organic intestinal disease
- having had intestinal surgery
- abdominal or pelvic radiation, carcinoma, obstructive disease, malabsorption disease
- fecal mass in the rectum which cannot be completely evacuated during the screening wash-out period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG 4000 (Forlax ®) | Drug | – |
Primary outcome
Clinical and biological tolerance with special attention to digestive and nutritional status. Clinical tolerance will be assessed by digestive symptomatology collected on a daily basis
Digestive examination assessed at screening wash-out period and each month
Nutritional status assessed at screening wash-out period, month 3 and month 6
Vital signs assessed at screening wash-out period, month 3 and month 6. Biological tolerance will be assessed by nutritional markers, malabsorption markers and routine laboratory tests assessed at screening wash-out period and month 3 and 6.
Drug interaction assessment assessed at screening wash-out period and month 3 and 6.
2 secondary outcomes
Long term efficacy based on daily nurse diary
Healthcare cost analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
146 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG 4000 (Forlax ®) in people with Constipation, run by Ipsen at 146 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 146 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and biological tolerance with special attention to digestive and nutritional status. Clinical tolerance will be assessed by digestive symptomatology collected on a daily basis. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.