check_circleStudy Completed
relapsing-remitting multiple sclerosis
Bayer Identifier:
91489
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Safety study in relapsing-remitting multiple sclerosis (RRMS) patients receiving Betaferon or Rebif
Trial purpose
The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.
Key Participants Requirements
Sex
BothAge
18 - 55 YearsTrial summary
Enrollment Goal
220Trial Dates
March 2006 - April 2008Phase
Phase 4Could I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Aix en Provence, 13616, France | |
Completed | Belfort, France | |
Completed | Blaye, France | |
Completed | Bordeaux, 33000, France | |
Completed | Brest Cedex, France | |
Completed | Brive La Gaillarde, 19100, France | |
Completed | Carcassonne, France | |
Completed | Champigny sur Marne, France | |
Completed | Colmar, France | |
Completed | Créteil, 94000, France | |
Completed | Dijon, France | |
Completed | Dunkerque, 59140, France | |
Completed | Evry, France | |
Completed | Le Mans, 72000, France | |
Completed | Lomme Cedex, France | |
Completed | Montpellier Cedex 5, France | |
Completed | Nancy, 54000, France | |
Completed | Nancy Cedex, France | |
Completed | Nice, France | |
Completed | Paris, France | |
Completed | Perpignan, 66000, France | |
Completed | Quimper, 29000, France | |
Completed | Quimper Cedex, France | |
Completed | Rennes, France | |
Completed | Alkirch, France | |
Completed | Annecy Cedex, 74011, France | |
Completed | Aurillac, 15000, France | |
Completed | Boulogne sur Mer, 62321, France | |
Completed | Castelnau le Lez, 34170, France | |
Completed | Chamaliÿres, France | |
Completed | Corbeil Essones Cedex, France | |
Completed | Dreux, France | |
Completed | Elbeuf, France | |
Completed | Evreux Cedex, 27023, France | |
Completed | La Seyne sur Mer, 83500, France | |
Completed | Le Mans Cedex, France | |
Completed | Libourne Cedex, 33505, France | |
Completed | Lille, France | |
Completed | Lyon, France | |
Completed | Marseille, 13006, France | |
Completed | Montpellier, France | |
Completed | Nantes, 44000, France | |
Completed | Nimes Cedex 9, 30900, France | |
Completed | Pau, France | |
Completed | Poissy, France | |
Completed | Quimper, France | |
Completed | Reims, France | |
Completed | Rouen, France | |
Completed | Rueil Malmaison, France | |
Completed | Saint Quentin, France | |
Completed | St Lÿ, 50000, France | |
Completed | St Omer, 62505, France | |
Completed | Toulouse, 31400, France | |
Completed | Tourcoing, France | |
Completed | Vesoul, 70000, France | |
Completed | Saint Herblain, 44800, France | |
Completed | St Etienne, France | |
Completed | Strasbourg, France | |
Completed | Trelaze, France | |
Completed | Vendome, France | |
Completed | Vichy, France |
Primary Outcome
- Percentage of the sites developing a injection site reaction (ISR) reported by participants 24 hours after each injectiondate_rangeTime Frame:Up to 3 months assessed every 24 hours after each injectionenhanced_encryptionYesSafety Issue:
- Percentage of sites developing a injection site reaction (ISR) reported by participants 48 hours after each injectiondate_rangeTime Frame:Up to 3 months assessed every 48 hours after each injectionenhanced_encryptionYesSafety Issue:
- Mean scores of reaction after injection reported by participantsdate_rangeTime Frame:Up to 3 months assessed every 24 and 48 hours after injectionenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Percentage of injection sites with pain reported by physiciansdate_rangeTime Frame:Up to 3 monthsenhanced_encryptionYesSafety Issue:
- Percentage of injection sites per participant with reaction reported by physiciansdate_rangeTime Frame:Up to 3 monthsenhanced_encryptionYesSafety Issue:
- Percentage of participants without ISR reported by participantsdate_rangeTime Frame:Up to 3 months assessed every 24 hours after each injectionenhanced_encryptionYesSafety Issue:
- Percentage of sites developing a severe reaction 24 hours after injectiondate_rangeTime Frame:Up to 3 months assessed every 24 hours after each injectionenhanced_encryptionYesSafety Issue:
- Percentage of sites developing a severe reaction 48 hours after injectiondate_rangeTime Frame:Up to 3 months assessed every 48 hours after each injectionenhanced_encryptionYesSafety Issue:
- Percentage of participants without pain reported by participantsdate_rangeTime Frame:Up to 3 months assessed 24 hours after each injectionenhanced_encryptionNoSafety Issue:
- Percentage of injection sites without pain reported by physiciansdate_rangeTime Frame:Up to 3 monthsenhanced_encryptionNoSafety Issue:
- Percentage of injection sites without pain reported by participantsdate_rangeTime Frame:Up to 3 months assessed 24 hours after each injectionenhanced_encryptionNoSafety Issue:
- Mean pain assessment using visual analogue scale (VAS) reported by participants immediately after injectiondate_rangeTime Frame:Immediately after injectionenhanced_encryptionNoSafety Issue:
- Mean pain assessment using visual analogue scale (VAS) reported by participants 30 minutes after injectiondate_rangeTime Frame:30 min after injectionenhanced_encryptionNoSafety Issue:
- Mean pain assessment using visual analogue scale (VAS) reported by participants 1 hour after injectiondate_rangeTime Frame:1h after injectionenhanced_encryptionNoSafety Issue:
- Mean pain assessment using visual analogue scale (VAS) reported by participants 24 hours after injectiondate_rangeTime Frame:24h after injectionenhanced_encryptionNoSafety Issue:
- Percentage of sites without reaction 24 hours after injection reported by participantsdate_rangeTime Frame:Up to 3 months assessed every 24 hours after each injectionenhanced_encryptionYesSafety Issue:
- Percentage of sites without reaction 48 hours after injection reported by participantsdate_rangeTime Frame:Up to 3 months assessed every 48 hours after each injectionenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
3