Study of Long-term Use of Forlax® in Elderly Patients With Chronic Constipation
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.
1 other identifier
interventional
246
1 country
146
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 1999
146 active sites
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, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2001
CompletedFirst Submitted
Initial submission to the registry
January 12, 2006
CompletedFirst Posted
Study publicly available on registry
January 13, 2006
CompletedJuly 26, 2019
July 1, 2019
January 12, 2006
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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 has less than 3 stools during 7 consecutive days of the screening wash-out period
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (146)
19 rue Jules Guesde
Abscon, 59215, France
Centre Saint Victor
Amiens, 80054, France
117 ter rue Jean Jaurès
Anzin, 59410, France
8 rue Jean Jaurès
Anzin, 59410, France
26 av. Charles de Gaulle
Aubevoye, 27940, France
89 avenue de Niort
Beauvoir-sur-Niort, 79360, France
11 Place de la République
Blois, 41000, France
39, avenue de France
Blois, 41000, France
30 rue Bayeux
Bretteville-l'Orgueilleuse, 14740, France
30 rue Pasteur
Bruille-lez-Marchiennes, 59490, France
6 avenue du 6 Juin
Caen, 14000, France
98 Boulevard du Maréchal Lyautey
Caen, 14000, France
Rue de l'Hôtel de Ville
Carquefou, 44470, France
La Cerisaie
Castelmaurou, 31180, France
33 rue Gambetta
Château-Renault, 37110, France
94 bis bld de la République
Châtelaillon-Plage, 17340, France
25 avenue de Nantes
Cholet, 49300, France
116 rue Henri Barbusse
Denain, 59220, France
25 Place Gambetta
Denain, 59220, France
6 rue de Ronde
Derval, 44590, France
CHS de la Chartreuse
Dijon, 21000, France
10 rue du Soleil Couchant
Dompierre-sur-Mer, 17139, France
19, avenue de la Gare
Droué, 41270, France
5 route de Paris
Écouis, 27440, France
1 rue du Jardin Botanique
Évreux, 27000, France
6 Centre Commercial les Peupliers
Évreux, 27000, France
8 bis rue du Bout du Pont
Faverolles-sur-Cher, 41400, France
9 rue Cure
Fenioux, 79160, France
15 rue Taffin
Fresnes-sur-Escaut, 59970, France
95 rue Jean-Jaurès
Fresnes-sur-Escaut, 59970, France
14 av. Aristide Briand
Gravigny, 27930, France
CHU Grenoble
Grenoble, 38043, France
Hôpital Charles Foix
Ivry-sur-Seine, 94205, France
Résidence, Grand Maison
L'Union, 31240, France
13 rue Balletant
La Ferté-Imbault, 41300, France
62 rue de Lattre
La Forêt-sur-Sèvre, 79380, France
121 rue M. Delage
La Garde, 83130, France
8 Chemin des Vendéens
La Jubaudière, 49510, France
11 place Sainte Anne
La Riche, 37520, France
194 rue Marius Lacroix
La Rochelle, 17000, France
28 rue du Paradis
La Séguinière, 49280, France
215 route de Bretagne
La Verenne, 44270, France
1, rue de l'Egalité
Lamotte-Beuvron, 41600, France
7 rue de Bel Air
Le Cellier, 44850, France
60 rue de la République
Le Neubourg, 27110, France
Hôpital Saint Julien
Le Petit-Quevilly, 76140, France
Hôpital Saint-Julien
Le Petit-Quevilly, 76140, France
21 Avenue Gabriel Péri
Le Pradet, 83220, France
360 Avenue de la 1ère DFL
Le Pradet, 83220, France
360, avenue de la 1ère DFL
Le Pradet, 83220, France
390 av. de la lère DFL
Le Pradet, 83220, France
46 Place Paul Flamenq
Le Pradet, 83220, France
61 avenue de la lère DFL
Le Pradet, 83220, France
13 rue de la Libération
Les Andelys, 27700, France
Maison de Retrate Saint-Jean
Lille, 59000, France
57 rue Dupont de l'Eure
Louviers, 27400, France
9 rue du Chatel
Louviers, 27400, France
Bd Clémenceau
Louviers, 27400, France
8 rue Saint Venant
Luynes, 37230, France
1 rue Pavée
Mainneville, 27150, France
Centre de Gérontologie, Yvon Lamour
Maniquerville, 76400, France
4 rue de Champagne
Marly, 59770, France
10 rue des Vignes
Ménigoute, 79340, France
94 rue Henri Urbain
Mortagne-du-Nord, 59158, France
25 rue V. Désormeaux
Mûrs-Erigné, 49610, France
181 rue Paul Bellamy
Nantes, 44000, France
101 Boulevard de Doulon
Nantes, 44300, France
63 rue de la Bottière
Nantes, 44300, France
13 av. de la République
Niort, 79000, France
189 Avenue de la Rochelle
Niort, 79000, France
277 av. de la Rochelle
Niort, 79000, France
6 pl. de la Comédie
Niort, 79000, France
24 rue de la Poste
Niort-Souche, 79000, France
30 Boulevard de la Gare
Nort-sur-Erdre, 44390, France
12 place d'Armes
Nueil-sur-Layon, 49560, France
26 Place Pasteur
Onnaing, 59624, France
76 rue des Ormeaux
Oudon, 44521, France
16 rue Aristide Briand
Pacy-sur-Eure, 27120, France
Hôpital Pitié Salpétrière
Paris, 75561, France
Centre Hospitalier Sud Hôpital Xavier Arnozan
Pessac, 33604, France
14 rue de Valencay
Périgny, 17180, France
14 rue de Valençay
Périgny, 17180, France
3 Rue Nouvelle
Pierrefitte-sur-Sauldre, 41300, France
29 rue Blin
Pont-de-l'Arche, 27340, France
35 bis rue du Général de Gaulle
Pont-de-l'Arche, 27340, France
28 bis route de Niort
Prahecq, 79230, France
7 rue Gambetta
Quarouble, 59243, France
271 rue Henri Durre
Raismes, 59590, France
338 rue Henri Durre
Raismes, 59590, France
Hôpital Boisguillaume - CHU de Rouen
Rouen, 76031, France
Hôpital Charles Nicolle - Service de Biochimie Médicale
Rouen, 76031, France
Hôpital Charles Nicolle - Service de Gastroentérologie et Nutrition
Rouen, 76031, France
Centre Hospitalier
Saint-Amand-les-Eaux, 59230, France
30 av. du Gl. de Gaulle
Saint-Avertin, 37550, France
Centre de Long Séjour
Saint-Chamond, 42400, France
Centre Hospitalier St Chamond
Saint-Chamond, 42400, France
5 rue Saint Nicolas
Saint-Germain-de-Marencennes, 17700, France
1 rue Vanneau
Saint-Jean-de-Liversay, 17170, France
Hôpital de Saint Jean de luz
Saint-Jean-de-Luz, 64500, France
34 rue du Poirier
Saint-Macaire-en-Mauges, 49450, France
53 bld du 8 Mai 1945
Saint-Macaire-en-Mauges, 49450, France
Les jardins de Rambam
Saint-Orens-de-Gameville, 31650, France
Maison de retraite
Saint-Orens-de-Gameville, 31650, France
36 Rue Louise Michel
Saint-Ouen, 41100, France
Chemin Vert
Saint-Pierre-des-Échaubrognes, 79700, France
Rue du Petit Montrevault
Saint-Pierre-Montlimart, 49110, France
Chemin de la Choisière
Saint-Rémy-en-Mauges, 49110, France
27 rue Principale
Saint-Romain-sur-Cher, 41140, France
12, rue Jean Cocteau
Saint-Saulve, 59880, France
1 Allée Jean Restout
Saint-Sébastien-de-Morsent, 27180, France
19 rue de la Mairie
Saint-Vincent-des-Landes, 44590, France
116 bis rue du 14 Juillet
Sainte-Marie-de-Ré, 17740, France
31 bis rue de la République
Sainte-Marie-de-Ré, 17740, France
Les Vergers du Château
Solliès-Pont, 83210, France
31 bis rue de la République
Ste Marie En Ré, 17740, France
28 rue Roger Salengro
Thiant, 59224, France
18 rue de la Baronne
Thilouze, 37260, France
1 rue de Bayeux
Tilly-sur-Seulles, 14250, France
121 av. de la Résistance
Toulon, 83000, France
148 Avenue Cuzin
Toulon, 83000, France
355 Avenue Claret
Toulon, 83000, France
535 av. de la Résistance
Toulon, 83000, France
6 bld Noble le Piermone
Toulon, 83000, France
641 rue Sainte Claire Deville
Toulon, 83000, France
641 rue Sainte Deville
Toulon, 83000, France
15 rue Gimelli
Toulon, 83100, France
112 Avenue du Xvème corps
Toulon, 83200, France
2 pl. Martin Bidouré
Toulon, 83200, France
4 pl. Jean Macé
Toulon, 83200, France
Capitole Santé
Toulouse, 31000, France
Hostellerie Languedocienne
Toulouse, 31000, France
Hôpital de la Grave-Casse Lardit
Toulouse, 31052, France
Résidence St Simon
Toulouse, 31500, France
3 rue Maryse Bastié
Tours, 37000, France
81 rue Blaise Pascal
Tours, 37000, France
13 rue Ernest Huard
Tours, 37100, France
Centre de Gériatrie du Comte Henry
Troyes, 10000, France
Centre Hospitalier de Troyes
Troyes, 10000, France
9 rue Beaurepaire
Valanjou, 49670, France
16 rue Anatole France
Valenciennes, 59300, France
Résidence Saly - 2 rue S. Lebourg
Valenciennes, 59300, France
200 rue Jean Jaurès
Vieux-Condé, 59690, France
4 rue Beaurepaire
Vihiers, 49310, France
Hôpital Paul Brousse
Villejuif, 94804, France
4, Place Jules Verne
Vineuil, 41350, France
85 rue Jean Jaurès
Wallers, 59135, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2006
First Posted
January 13, 2006
Study Start
December 1, 1999
Study Completion
November 20, 2001
Last Updated
July 26, 2019
Record last verified: 2019-07