Clinical trial NCT00276354: Study of Long-term Use of Forlax® in Elderly Patients With Chronic Constipation
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-01-13
Enrollment: 246
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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
measure: Digestive examination assessed at screening wash-out period and each month
measure: Nutritional status assessed at screening wash-out period, month 3 and month 6
measure: 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.
measure: Drug interaction assessment assessed at screening wash-out period and month 3 and 6.
Secondary outcomes:
measure: Long term efficacy based on daily nurse diary
measure: Healthcare cost analysis.
Other outcomes:
Locations:
city: Abscon
country: France
facility: 19 rue Jules Guesde
city: Amiens
country: France
facility: Centre Saint Victor
city: Anzin
country: France
facility: 117 ter rue Jean Jaurès
city: Anzin
country: France
facility: 8 rue Jean Jaurès
city: Aubevoye
country: France
facility: 26 av. Charles de Gaulle
city: Beauvoir Sur Niort
country: France
facility: 89 avenue de Niort
city: Blois
country: France
facility: 11 Place de la République
city: Blois
country: France
facility: 39, avenue de France
city: Bretteville l'Orgueilleuse
country: France
facility: 30 rue Bayeux
city: Bruille Les Marchiennes
country: France
facility: 30 rue Pasteur
city: Caen
country: France
facility: 6 avenue du 6 Juin
city: Caen
country: France
facility: 98 Boulevard du Maréchal Lyautey
city: Carquefou
country: France
facility: Rue de l'Hôtel de Ville
city: Castel Maurou
country: France
facility: La Cerisaie
city: Chateau Renault
country: France
facility: 33 rue Gambetta
city: Chatelaillon Plage
country: France
facility: 94 bis bld de la République
city: Cholet
country: France
facility: 25 avenue de Nantes
city: Denain
country: France
facility: 116 rue Henri Barbusse
city: Denain
country: France
facility: 25 Place Gambetta
city: Derval
country: France
facility: 6 rue de Ronde
city: Dijon
country: France
facility: CHS de la Chartreuse
city: Dompierre Sur Mer
country: France
facility: 10 rue du Soleil Couchant
city: Droue
country: France
facility: 19, avenue de la Gare
city: Ecouis
country: France
facility: 5 route de Paris
city: Evreux
country: France
facility: 1 rue du Jardin Botanique
city: Evreux
country: France
facility: 6 Centre Commercial les Peupliers
city: Faverolles-sur-Cher
country: France
facility: 8 bis rue du Bout du Pont
city: Fenioux
country: France
facility: 9 rue Cure
city: Fresnes-sur-Escaut
country: France
facility: 15 rue Taffin
city: Fresnes-sur-Escaut
country: France
facility: 95 rue Jean-Jaurès
city: Gravigny
country: France
facility: 14 av. Aristide Briand
city: Grenoble
country: France
facility: CHU Grenoble
city: Ivry sur Seine
country: France
facility: Hôpital Charles Foix
city: L'Union
country: France
facility: Résidence, Grand Maison
city: La Ferte Imbault
country: France
facility: 13 rue Balletant
city: La Foret Sur Sevre
country: France
facility: 62 rue de Lattre
city: La Garde
country: France
facility: 121 rue M. Delage
city: La Jubaudiere
country: France
facility: 8 Chemin des Vendéens
city: La Riche
country: France
facility: 11 place Sainte Anne
city: La Rochelle
country: France
facility: 194 rue Marius Lacroix
city: La Seguiniere
country: France
facility: 28 rue du Paradis
city: La Verenne
country: France
facility: 215 route de Bretagne
city: Lamotte Beuvron
country: France
facility: 1, rue de l'Egalité
city: Le Cellier
country: France
facility: 7 rue de Bel Air
city: Le Neubourg
country: France
facility: 60 rue de la République
city: Le Petit Quevilly
country: France
facility: Hôpital Saint Julien
city: Le Pradet
country: France
facility: 21 Avenue Gabriel Péri
city: Le Pradet
country: France
facility: 360 Avenue de la 1ère DFL
city: Le Pradet
country: France
facility: 360, avenue de la 1ère DFL
city: Le Pradet
country: France
facility: 390 av. de la lère DFL
city: Le Pradet
country: France
facility: 46 Place Paul Flamenq
city: Le Pradet
country: France
facility: 61 avenue de la lère DFL
city: Les Andelys
country: France
facility: 13 rue de la Libération
city: Lille
country: France
facility: Maison de Retrate Saint-Jean
city: Louviers
country: France
facility: 57 rue Dupont de l'Eure
city: Louviers
country: France
facility: 9 rue du Chatel
city: Louviers
country: France
facility: Bd Clémenceau
city: Luynes
country: France
facility: 8 rue Saint Venant
city: Mainneville
country: France
facility: 1 rue Pavée
city: Maniquerville
country: France
facility: Centre de Gérontologie, Yvon Lamour
city: Marly
country: France
facility: 4 rue de Champagne
city: Menigoute
country: France
facility: 10 rue des Vignes
city: Mortagne du Nord
country: France
facility: 94 rue Henri Urbain
city: Murs Erigne
country: France
facility: 25 rue V. Désormeaux
city: Nantes
country: France
facility: 181 rue Paul Bellamy
city: Nantes
country: France
facility: 101 Boulevard de Doulon
city: Nantes
country: France
facility: 63 rue de la Bottière
city: Niort-Souche
country: France
facility: 24 rue de la Poste
city: Niort
country: France
facility: 13 av. de la République
city: Niort
country: France
facility: 189 Avenue de la Rochelle
city: Niort
country: France
facility: 277 av. de la Rochelle
city: Niort
country: France
facility: 6 pl. de la Comédie
city: Nort-sur-Erdre
country: France
facility: 30 Boulevard de la Gare
city: Nueil Sur Layon
country: France
facility: 12 place d'Armes
city: Onnaing
country: France
facility: 26 Place Pasteur
city: Oudon
country: France
facility: 76 rue des Ormeaux
city: Pacy sur Eure
country: France
facility: 16 rue Aristide Briand
city: Paris
country: France
facility: Hôpital Pitié Salpétrière
city: Perigny
country: France
facility: 14 rue de Valencay
city: Perigny
country: France
facility: 14 rue de Valençay
city: Pessac
country: France
facility: Centre Hospitalier Sud Hôpital Xavier Arnozan
city: Petit Quevilly
country: France
facility: Hôpital Saint-Julien
city: Pierrefitte Sur Sauldre
country: France
facility: 3 Rue Nouvelle
city: Pont De L'arche
country: France
facility: 29 rue Blin
city: Pont-de-l'Arche
country: France
facility: 35 bis rue du Général de Gaulle
city: Prahecq
country: France
facility: 28 bis route de Niort
city: Quarouble
country: France
facility: 7 rue Gambetta
city: Raismes
country: France
facility: 271 rue Henri Durre
city: Raismes
country: France
facility: 338 rue Henri Durre
city: Rouen
country: France
facility: Hôpital Boisguillaume - CHU de Rouen
city: Rouen
country: France
facility: Hôpital Charles Nicolle - Service de Biochimie Médicale
city: Rouen
country: France
facility: Hôpital Charles Nicolle - Service de Gastroentérologie et Nutrition
city: Saint Amand les Eaux
country: France
facility: Centre Hospitalier
city: Saint Avertin
country: France
facility: 30 av. du Gl. de Gaulle
city: Saint Chamond
country: France
facility: Centre Hospitalier St Chamond
city: Saint Orens De Gameville
country: France
facility: Maison de retraite
city: Saint Ouen
country: France
facility: 36 Rue Louise Michel
city: Saint Romain Sur Cher
country: France
facility: 27 rue Principale
city: Saint Saulve
country: France
facility: 12, rue Jean Cocteau
city: Saint-Chamond
country: France
facility: Centre de Long Séjour
city: Saint-Germain-de-Marencennes
country: France
facility: 5 rue Saint Nicolas
city: Saint-Jean-de-Liversay
country: France
facility: 1 rue Vanneau
city: Saint-Jean-De-Luz
country: France
facility: Hôpital de Saint Jean de luz
city: Saint-Macaire-en-Mauges
country: France
facility: 34 rue du Poirier
city: Saint-Macaire-en-Mauges
country: France
facility: 53 bld du 8 Mai 1945
city: Saint-Orens-de-Gameville
country: France
facility: Les jardins de Rambam
city: Saint-Pierre-des-Echaubrognes
country: France
facility: Chemin Vert
city: Saint-Pierre-Montlimart
country: France
facility: Rue du Petit Montrevault
city: Saint-Remy-en-Mauges
country: France
facility: Chemin de la Choisière
city: Saint-Sebastien-de-Morsent
country: France
facility: 1 Allée Jean Restout
city: Saint-Vincent des Landes
country: France
facility: 19 rue de la Mairie
city: Sainte-Marie-de-Re
country: France
facility: 116 bis rue du 14 Juillet
city: Sainte-Marie-de-Re
country: France
facility: 31 bis rue de la République
city: Sollies-Pont
country: France
facility: Les Vergers du Château
city: Ste Marie En Ré
country: France
facility: 31 bis rue de la République
city: Thiant
country: France
facility: 28 rue Roger Salengro
city: Thilouze
country: France
facility: 18 rue de la Baronne
city: Tilly sur Seulles
country: France
facility: 1 rue de Bayeux
city: Toulon
country: France
facility: 121 av. de la Résistance
city: Toulon
country: France
facility: 148 Avenue Cuzin
city: Toulon
country: France
facility: 355 Avenue Claret
city: Toulon
country: France
facility: 535 av. de la Résistance
city: Toulon
country: France
facility: 6 bld Noble le Piermone
city: Toulon
country: France
facility: 641 rue Sainte Claire Deville
city: Toulon
country: France
facility: 641 rue Sainte Deville
city: Toulon
country: France
facility: 15 rue Gimelli
city: Toulon
country: France
facility: 112 Avenue du Xvème corps
city: Toulon
country: France
facility: 2 pl. Martin Bidouré
city: Toulon
country: France
facility: 4 pl. Jean Macé
city: Toulouse
country: France
facility: Capitole Santé
city: Toulouse
country: France
facility: Hostellerie Languedocienne
city: Toulouse
country: France
facility: Hôpital de la Grave-Casse Lardit
city: Toulouse
country: France
facility: Résidence St Simon
city: Tours
country: France
facility: 3 rue Maryse Bastié
city: Tours
country: France
facility: 81 rue Blaise Pascal
city: Tours
country: France
facility: 13 rue Ernest Huard
city: Troyes
country: France
facility: Centre de Gériatrie du Comte Henry
city: Troyes
country: France
facility: Centre Hospitalier de Troyes
city: Valanjou
country: France
facility: 9 rue Beaurepaire
city: Valenciennes
country: France
facility: 16 rue Anatole France
city: Valenciennes
country: France
facility: Résidence Saly - 2 rue S. Lebourg
city: Vieux Conde
country: France
facility: 200 rue Jean Jaurès
city: Vihiers
country: France
facility: 4 rue Beaurepaire
city: Villejuif
country: France
facility: Hôpital Paul Brousse
city: Vineuil
country: France
facility: 4, Place Jules Verne
city: Wallers
country: France
facility: 85 rue Jean Jaurès
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: