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

July 24, 2019 updated by: Ipsen

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.

Study Overview

Status

Completed

Conditions

Constipation

Intervention / Treatment

Drug: PEG 4000 (Forlax ®)

Study Type

Interventional

Enrollment (Actual)

246

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Abscon, France, 59215
    - 19 rue Jules Guesde
  - Amiens, France, 80054
    - Centre Saint Victor
  - Anzin, France, 59410
    - 117 ter rue Jean Jaurès
  - Anzin, France, 59410
    - 8 rue Jean Jaurès
  - Aubevoye, France, 27940
    - 26 av. Charles de Gaulle
  - Beauvoir Sur Niort, France, 79360
    - 89 avenue de Niort
  - Blois, France, 41000
    - 11 Place de la République
  - Blois, France, 41000
    - 39, avenue de France
  - Bretteville l'Orgueilleuse, France, 14740
    - 30 rue Bayeux
  - Bruille Les Marchiennes, France, 59490
    - 30 rue Pasteur
  - Caen, France, 14000
    - 6 avenue du 6 Juin
  - Caen, France, 14000
    - 98 Boulevard du Maréchal Lyautey
  - Carquefou, France, 44470
    - Rue de l'Hôtel de Ville
  - Castel Maurou, France, 31180
    - La Cerisaie
  - Chateau Renault, France, 37110
    - 33 rue Gambetta
  - Chatelaillon Plage, France, 17340
    - 94 bis bld de la République
  - Cholet, France, 49300
    - 25 avenue de Nantes
  - Denain, France, 59220
    - 116 rue Henri Barbusse
  - Denain, France, 59220
    - 25 Place Gambetta
  - Derval, France, 44590
    - 6 rue de Ronde
  - Dijon, France, 21000
    - CHS de la Chartreuse
  - Dompierre Sur Mer, France, 17139
    - 10 rue du Soleil Couchant
  - Droue, France, 41270
    - 19, avenue de la Gare
  - Ecouis, France, 27440
    - 5 route de Paris
  - Evreux, France, 27000
    - 1 rue du Jardin Botanique
  - Evreux, France, 27000
    - 6 Centre Commercial les Peupliers
  - Faverolles-sur-Cher, France, 41400
    - 8 bis rue du Bout du Pont
  - Fenioux, France, 79160
    - 9 rue Cure
  - Fresnes-sur-Escaut, France, 59970
    - 15 rue Taffin
  - Fresnes-sur-Escaut, France, 59970
    - 95 rue Jean-Jaurès
  - Gravigny, France, 27930
    - 14 av. Aristide Briand
  - Grenoble, France, 38043
    - Chu Grenoble
  - Ivry sur Seine, France, 94205
    - Hôpital Charles Foix
  - L'Union, France, 31240
    - Résidence, Grand Maison
  - La Ferte Imbault, France, 41300
    - 13 rue Balletant
  - La Foret Sur Sevre, France, 79380
    - 62 rue de Lattre
  - La Garde, France, 83130
    - 121 rue M. Delage
  - La Jubaudiere, France, 49510
    - 8 Chemin des Vendéens
  - La Riche, France, 37520
    - 11 Place Sainte Anne
  - La Rochelle, France, 17000
    - 194 rue Marius Lacroix
  - La Seguiniere, France, 49280
    - 28 rue du Paradis
  - La Verenne, France, 44270
    - 215 route de Bretagne
  - Lamotte Beuvron, France, 41600
    - 1, rue de l'Egalité
  - Le Cellier, France, 44850
    - 7 rue de Bel Air
  - Le Neubourg, France, 27110
    - 60 rue de la République
  - Le Petit Quevilly, France, 76140
    - Hôpital Saint Julien
  - Le Pradet, France, 83220
    - 21 Avenue Gabriel Péri
  - Le Pradet, France, 83220
    - 360 Avenue de la 1ère DFL
  - Le Pradet, France, 83220
    - 360, avenue de la 1ère DFL
  - Le Pradet, France, 83220
    - 390 av. de la lère DFL
  - Le Pradet, France, 83220
    - 46 Place Paul Flamenq
  - Le Pradet, France, 83220
    - 61 avenue de la lère DFL
  - Les Andelys, France, 27700
    - 13 rue de la Libération
  - Lille, France, 59000
    - Maison de Retrate Saint-Jean
  - Louviers, France, 27400
    - 57 rue Dupont de l'Eure
  - Louviers, France, 27400
    - 9 rue du Chatel
  - Louviers, France, 27400
    - Bd Clémenceau
  - Luynes, France, 37230
    - 8 rue Saint Venant
  - Mainneville, France, 27150
    - 1 rue Pavée
  - Maniquerville, France, 76400
    - Centre de Gérontologie, Yvon Lamour
  - Marly, France, 59770
    - 4 rue de Champagne
  - Menigoute, France, 79340
    - 10 rue des Vignes
  - Mortagne du Nord, France, 59158
    - 94 rue Henri Urbain
  - Murs Erigne, France, 49610
    - 25 rue V. Désormeaux
  - Nantes, France, 44000
    - 181 rue Paul Bellamy
  - Nantes, France, 44300
    - 101 Boulevard de Doulon
  - Nantes, France, 44300
    - 63 rue de la Bottière
  - Niort, France, 79000
    - 13 av. de la République
  - Niort, France, 79000
    - 189 Avenue de la Rochelle
  - Niort, France, 79000
    - 277 av. de la Rochelle
  - Niort, France, 79000
    - 6 pl. de la Comédie
  - Niort-Souche, France, 79000
    - 24 rue de la Poste
  - Nort-sur-Erdre, France, 44390
    - 30 Boulevard de la Gare
  - Nueil Sur Layon, France, 49560
    - 12 place d'Armes
  - Onnaing, France, 59624
    - 26 Place Pasteur
  - Oudon, France, 44521
    - 76 rue des Ormeaux
  - Pacy sur Eure, France, 27120
    - 16 rue Aristide Briand
  - Paris, France, 75561
    - Hôpital Pitie Salpétrière
  - Perigny, France, 17180
    - 14 rue de Valençay
  - Pessac, France, 33604
    - Centre Hospitalier Sud Hôpital Xavier Arnozan
  - Petit Quevilly, France, 76140
    - Hôpital Saint-Julien
  - Pierrefitte Sur Sauldre, France, 41300
    - 3 Rue Nouvelle
  - Pont De L'arche, France, 27340
    - 29 rue Blin
  - Pont-de-l'Arche, France, 27340
    - 35 bis rue du Général de Gaulle
  - Prahecq, France, 79230
    - 28 bis route de Niort
  - Quarouble, France, 59243
    - 7 rue Gambetta
  - Raismes, France, 59590
    - 271 rue Henri Durre
  - Raismes, France, 59590
    - 338 rue Henri Durre
  - Rouen, France, 76031
    - Hôpital Boisguillaume - CHU de Rouen
  - Rouen, France, 76031
    - Hôpital Charles Nicolle - Service de Biochimie Médicale
  - Rouen, France, 76031
    - Hôpital Charles Nicolle - Service de Gastroentérologie et Nutrition
  - Saint Amand les Eaux, France, 59230
    - Centre Hospitalier
  - Saint Avertin, France, 37550
    - 30 av. du Gl. de Gaulle
  - Saint Chamond, France, 42400
    - Centre Hospitalier St Chamond
  - Saint Orens De Gameville, France, 31650
    - Maison de retraite
  - Saint Ouen, France, 41100
    - 36 Rue Louise Michel
  - Saint Romain Sur Cher, France, 41140
    - 27 rue Principale
  - Saint Saulve, France, 59880
    - 12, rue Jean Cocteau
  - Saint-Chamond, France, 42400
    - Centre de Long Séjour
  - Saint-Germain-de-Marencennes, France, 17700
    - 5 rue Saint Nicolas
  - Saint-Jean-De-Luz, France, 64500
    - Hôpital de Saint Jean de luz
  - Saint-Jean-de-Liversay, France, 17170
    - 1 rue Vanneau
  - Saint-Macaire-en-Mauges, France, 49450
    - 34 rue du Poirier
  - Saint-Macaire-en-Mauges, France, 49450
    - 53 bld du 8 Mai 1945
  - Saint-Orens-de-Gameville, France, 31650
    - Les jardins de Rambam
  - Saint-Pierre-Montlimart, France, 49110
    - Rue du Petit Montrevault
  - Saint-Pierre-des-Echaubrognes, France, 79700
    - Chemin Vert
  - Saint-Remy-en-Mauges, France, 49110
    - Chemin de la Choisière
  - Saint-Sebastien-de-Morsent, France, 27180
    - 1 allee Jean Restout
  - Saint-Vincent des Landes, France, 44590
    - 19 rue de la Mairie
  - Sainte-Marie-de-Re, France, 17740
    - 116 bis rue du 14 Juillet
  - Sainte-Marie-de-Re, France, 17740
    - 31 bis rue de la République
  - Sollies-Pont, France, 83210
    - Les Vergers du Château
  - Ste Marie En Ré, France, 17740
    - 31 bis rue de la République
  - Thiant, France, 59224
    - 28 rue Roger Salengro
  - Thilouze, France, 37260
    - 18 rue de la Baronne
  - Tilly sur Seulles, France, 14250
    - 1 rue de Bayeux
  - Toulon, France, 83000
    - 121 av. de la Résistance
  - Toulon, France, 83000
    - 148 Avenue Cuzin
  - Toulon, France, 83000
    - 355 Avenue Claret
  - Toulon, France, 83000
    - 535 av. de la Résistance
  - Toulon, France, 83000
    - 6 bld Noble le Piermone
  - Toulon, France, 83000
    - 641 rue Sainte Claire Deville
  - Toulon, France, 83000
    - 641 rue Sainte Deville
  - Toulon, France, 83100
    - 15 rue Gimelli
  - Toulon, France, 83200
    - 112 Avenue du Xvème corps
  - Toulon, France, 83200
    - 2 pl. Martin Bidouré
  - Toulon, France, 83200
    - 4 pl. Jean Macé
  - Toulouse, France, 31000
    - Capitole Santé
  - Toulouse, France, 31000
    - Hostellerie Languedocienne
  - Toulouse, France, 31052
    - Hôpital de la Grave-Casse Lardit
  - Toulouse, France, 31500
    - Résidence St Simon
  - Tours, France, 37000
    - 3 rue Maryse Bastié
  - Tours, France, 37000
    - 81 rue Blaise Pascal
  - Tours, France, 37100
    - 13 rue Ernest Huard
  - Troyes, France, 10000
    - Centre de Gériatrie du Comte Henry
  - Troyes, France, 10000
    - Centre Hospitalier de Troyes
  - Valanjou, France, 49670
    - 9 rue Beaurepaire
  - Valenciennes, France, 59300
    - 16 rue Anatole France
  - Valenciennes, France, 59300
    - Résidence Saly - 2 rue S. Lebourg
  - Vieux Conde, France, 59690
    - 200 rue Jean Jaures
  - Vihiers, France, 49310
    - 4 Rue Beaurepaire
  - Villejuif, France, 94804
    - Hôpital Paul Brousse
  - Vineuil, France, 41350
    - 4, Place Jules Verne
  - Wallers, France, 59135
    - 85 rue Jean Jaurès

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

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
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 Outcome Measures

Outcome Measure
Long term efficacy based on daily nurse diary
Healthcare cost analysis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Study Completion (Actual)

November 20, 2001

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

2-31-52072-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.