Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orfagen
ClinicalTrials.gov Identifier:
NCT01084148
First received: March 9, 2010
Last updated: April 18, 2014
Last verified: April 2014
Results First Received: January 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Uremic Xerosis
Interventions: Drug: V0034CR01B
Drug: V0034CR01B vehicle

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Among the 237 enrolled patients: one patient not randomized. Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.

Reporting Groups
  Description
V0034CR01B

cream

V0034CR01B

V0034 CR 01B Vehicle

cream

V0034CR01B vehicle


Participant Flow:   Overall Study
    V0034CR01B     V0034 CR 01B Vehicle  
STARTED     118     118 [1]
COMPLETED     88     102  
NOT COMPLETED     30     16  
[1] Among those 118 patients randomized into V0034 CR 01B vehicle arm, one patient not treated.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

1 patient not randomised

1 patient in V0034 CR 01B vehicle group not treated


Reporting Groups
  Description
V0034CR01B

cream

V0034CR01B

V0034 CR 01B Vehicle

cream

V0034CR01B vehicle

Total Total of all reporting groups

Baseline Measures
    V0034CR01B     V0034 CR 01B Vehicle     Total  
Number of Participants  
[units: participants]
  118     118     236  
Age  
[units: years]
Mean ( Full Range )
  64.8  
  ( 26 to 89 )  
  64.5  
  ( 23 to 82 )  
  64.65  
  ( 23 to 89 )  
Gender  
[units: participants]
     
Female     48     53     101  
Male     70     65     135  



  Outcome Measures

1.  Primary:   Treatment Response of Xerosis   [ Time Frame: 28 days ]

2.  Secondary:   Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B   [ Time Frame: 133 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Project Manager
Organization: Orfagen
phone: 0033 5 34 50 64 62
e-mail: caroline.miklaszewski@orfagen.com


No publications provided


Responsible Party: Orfagen
ClinicalTrials.gov Identifier: NCT01084148     History of Changes
Other Study ID Numbers: V00034 CR 308 ORF
Study First Received: March 9, 2010
Results First Received: January 31, 2014
Last Updated: April 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: MINISTRY OF HEALTH AND SOCIAL SOLIDARITY NATIONAL DRUG ORGANIZATION (EOF)
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: State Institute for Drug Control