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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG 4000 (Forlax ®) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Long term efficacy based on daily nurse diary | ||
| Healthcare cost analysis. |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 19 rue Jules Guesde | Abscon | 59215 | France | |||
| Centre Saint Victor |
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| 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 |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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