Study of Long-term Use of Forlax® in Elderly Patients With Chronic Constipation

NCT ID: NCT00276354

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2001-11-20

Brief Summary

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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.

Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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PEG 4000 (Forlax ®)

Intervention Type DRUG

Eligibility Criteria

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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:

* 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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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19 rue Jules Guesde

Abscon, , France

Site Status

Centre Saint Victor

Amiens, , France

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117 ter rue Jean Jaurès

Anzin, , France

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8 rue Jean Jaurès

Anzin, , France

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26 av. Charles de Gaulle

Aubevoye, , France

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89 avenue de Niort

Beauvoir-sur-Niort, , France

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11 Place de la République

Blois, , France

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39, avenue de France

Blois, , France

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30 rue Bayeux

Bretteville-l'Orgueilleuse, , France

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30 rue Pasteur

Bruille-lez-Marchiennes, , France

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6 avenue du 6 Juin

Caen, , France

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98 Boulevard du Maréchal Lyautey

Caen, , France

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Rue de l'Hôtel de Ville

Carquefou, , France

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La Cerisaie

Castelmaurou, , France

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33 rue Gambetta

Château-Renault, , France

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94 bis bld de la République

Châtelaillon-Plage, , France

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25 avenue de Nantes

Cholet, , France

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116 rue Henri Barbusse

Denain, , France

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25 Place Gambetta

Denain, , France

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6 rue de Ronde

Derval, , France

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CHS de la Chartreuse

Dijon, , France

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10 rue du Soleil Couchant

Dompierre-sur-Mer, , France

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19, avenue de la Gare

Droué, , France

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5 route de Paris

Écouis, , France

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1 rue du Jardin Botanique

Évreux, , France

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6 Centre Commercial les Peupliers

Évreux, , France

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8 bis rue du Bout du Pont

Faverolles-sur-Cher, , France

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9 rue Cure

Fenioux, , France

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15 rue Taffin

Fresnes-sur-Escaut, , France

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95 rue Jean-Jaurès

Fresnes-sur-Escaut, , France

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14 av. Aristide Briand

Gravigny, , France

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CHU Grenoble

Grenoble, , France

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Hôpital Charles Foix

Ivry-sur-Seine, , France

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Résidence, Grand Maison

L'Union, , France

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13 rue Balletant

La Ferté-Imbault, , France

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62 rue de Lattre

La Forêt-sur-Sèvre, , France

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121 rue M. Delage

La Garde, , France

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8 Chemin des Vendéens

La Jubaudière, , France

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11 place Sainte Anne

La Riche, , France

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194 rue Marius Lacroix

La Rochelle, , France

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28 rue du Paradis

La Séguinière, , France

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215 route de Bretagne

La Verenne, , France

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1, rue de l'Egalité

Lamotte-Beuvron, , France

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7 rue de Bel Air

Le Cellier, , France

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60 rue de la République

Le Neubourg, , France

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Hôpital Saint Julien

Le Petit-Quevilly, , France

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Hôpital Saint-Julien

Le Petit-Quevilly, , France

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21 Avenue Gabriel Péri

Le Pradet, , France

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360 Avenue de la 1ère DFL

Le Pradet, , France

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360, avenue de la 1ère DFL

Le Pradet, , France

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390 av. de la lère DFL

Le Pradet, , France

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46 Place Paul Flamenq

Le Pradet, , France

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61 avenue de la lère DFL

Le Pradet, , France

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13 rue de la Libération

Les Andelys, , France

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Maison de Retrate Saint-Jean

Lille, , France

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57 rue Dupont de l'Eure

Louviers, , France

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9 rue du Chatel

Louviers, , France

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Bd Clémenceau

Louviers, , France

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8 rue Saint Venant

Luynes, , France

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1 rue Pavée

Mainneville, , France

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Centre de Gérontologie, Yvon Lamour

Maniquerville, , France

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4 rue de Champagne

Marly, , France

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10 rue des Vignes

Ménigoute, , France

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94 rue Henri Urbain

Mortagne-du-Nord, , France

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25 rue V. Désormeaux

Mûrs-Erigné, , France

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181 rue Paul Bellamy

Nantes, , France

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101 Boulevard de Doulon

Nantes, , France

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63 rue de la Bottière

Nantes, , France

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13 av. de la République

Niort, , France

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189 Avenue de la Rochelle

Niort, , France

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277 av. de la Rochelle

Niort, , France

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6 pl. de la Comédie

Niort, , France

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24 rue de la Poste

Niort-Souche, , France

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30 Boulevard de la Gare

Nort-sur-Erdre, , France

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12 place d'Armes

Nueil-sur-Layon, , France

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26 Place Pasteur

Onnaing, , France

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76 rue des Ormeaux

Oudon, , France

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16 rue Aristide Briand

Pacy-sur-Eure, , France

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Hôpital Pitié Salpétrière

Paris, , France

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Centre Hospitalier Sud Hôpital Xavier Arnozan

Pessac, , France

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14 rue de Valencay

Périgny, , France

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14 rue de Valençay

Périgny, , France

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3 Rue Nouvelle

Pierrefitte-sur-Sauldre, , France

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29 rue Blin

Pont-de-l'Arche, , France

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35 bis rue du Général de Gaulle

Pont-de-l'Arche, , France

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28 bis route de Niort

Prahecq, , France

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7 rue Gambetta

Quarouble, , France

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271 rue Henri Durre

Raismes, , France

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338 rue Henri Durre

Raismes, , France

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Hôpital Boisguillaume - CHU de Rouen

Rouen, , France

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Hôpital Charles Nicolle - Service de Biochimie Médicale

Rouen, , France

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Hôpital Charles Nicolle - Service de Gastroentérologie et Nutrition

Rouen, , France

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Centre Hospitalier

Saint-Amand-les-Eaux, , France

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30 av. du Gl. de Gaulle

Saint-Avertin, , France

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Centre de Long Séjour

Saint-Chamond, , France

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Centre Hospitalier St Chamond

Saint-Chamond, , France

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5 rue Saint Nicolas

Saint-Germain-de-Marencennes, , France

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1 rue Vanneau

Saint-Jean-de-Liversay, , France

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Hôpital de Saint Jean de luz

Saint-Jean-de-Luz, , France

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34 rue du Poirier

Saint-Macaire-en-Mauges, , France

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53 bld du 8 Mai 1945

Saint-Macaire-en-Mauges, , France

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Les jardins de Rambam

Saint-Orens-de-Gameville, , France

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Maison de retraite

Saint-Orens-de-Gameville, , France

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36 Rue Louise Michel

Saint-Ouen, , France

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Chemin Vert

Saint-Pierre-des-Échaubrognes, , France

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Rue du Petit Montrevault

Saint-Pierre-Montlimart, , France

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Chemin de la Choisière

Saint-Rémy-en-Mauges, , France

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27 rue Principale

Saint-Romain-sur-Cher, , France

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12, rue Jean Cocteau

Saint-Saulve, , France

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1 Allée Jean Restout

Saint-Sébastien-de-Morsent, , France

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19 rue de la Mairie

Saint-Vincent-des-Landes, , France

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116 bis rue du 14 Juillet

Sainte-Marie-de-Ré, , France

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31 bis rue de la République

Sainte-Marie-de-Ré, , France

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Les Vergers du Château

Solliès-Pont, , France

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31 bis rue de la République

Ste Marie En Ré, , France

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28 rue Roger Salengro

Thiant, , France

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18 rue de la Baronne

Thilouze, , France

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1 rue de Bayeux

Tilly-sur-Seulles, , France

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121 av. de la Résistance

Toulon, , France

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148 Avenue Cuzin

Toulon, , France

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355 Avenue Claret

Toulon, , France

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535 av. de la Résistance

Toulon, , France

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6 bld Noble le Piermone

Toulon, , France

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641 rue Sainte Claire Deville

Toulon, , France

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641 rue Sainte Deville

Toulon, , France

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15 rue Gimelli

Toulon, , France

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112 Avenue du Xvème corps

Toulon, , France

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2 pl. Martin Bidouré

Toulon, , France

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4 pl. Jean Macé

Toulon, , France

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Capitole Santé

Toulouse, , France

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Hostellerie Languedocienne

Toulouse, , France

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Hôpital de la Grave-Casse Lardit

Toulouse, , France

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Résidence St Simon

Toulouse, , France

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3 rue Maryse Bastié

Tours, , France

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81 rue Blaise Pascal

Tours, , France

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13 rue Ernest Huard

Tours, , France

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Centre de Gériatrie du Comte Henry

Troyes, , France

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Centre Hospitalier de Troyes

Troyes, , France

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9 rue Beaurepaire

Valanjou, , France

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16 rue Anatole France

Valenciennes, , France

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Résidence Saly - 2 rue S. Lebourg

Valenciennes, , France

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200 rue Jean Jaurès

Vieux-Condé, , France

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4 rue Beaurepaire

Vihiers, , France

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Hôpital Paul Brousse

Villejuif, , France

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4, Place Jules Verne

Vineuil, , France

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85 rue Jean Jaurès

Wallers, , France

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Countries

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France

Other Identifiers

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2-31-52072-003

Identifier Type: -

Identifier Source: org_study_id

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