A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients
NCT00929981
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- To be eligible for enrollment in this study, patients must be prescribed oral Medrol tablets (4mg and 16 mg) for contact dermatitis as per the locally approved prescribing information
- Medrol tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol tablet will necessarily precede and will be independent of the decision to enroll patient into the study
- Only those patients, who are ready to sign an informed consent, will be included in the study
- Subject can be contacted through telephone
- Patients who have any other dermatological or systemic condition that may interfere or
confound with the study outcome measurements
- Patients taking any oral steroid preparation or immunomodulators or have taken any
such oral medication during last 15 days before enrollment. NSAIDs (Non Steroidal
Anti-Inflammatory Agents) are excluded from the list
- Any contraindication to Medrol tablet use. Contraindications of Medrol use are
systemic fungal infections and known hypersensitivity to components
- Participation in other studies within last 1 month before the current study begins
and/or during study participation
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study
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Descriptive Information | ||||
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Brief Title | A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients | |||
Official Title | Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects | |||
Brief Summary | This study will be a prospective, non-interventional, single arm and open label study, in patients with contact dermatitis requiring systemic steroid therapy with a purpose to obtain the real life effectiveness and tolerability of Medrol in treating contact dermatitis in Indian patients. Patients with contact dermatitis who have been prescribed for Medrol will be enrolled into the study and will be followed up for the resolution of symptoms | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients who have been prescribed oral Medrol Tablets (4 or 16 mg) for treatment of contact dermatitis will be enrolled | |||
Condition | Dermatitis, Contact | |||
Intervention | Drug: Tablet Methylprednisolone (4 or 16 mg)
Oral Methylprednisolone tablets (4mg, 16mg) will be given as per locally approved prescribing information | |||
Study Groups/Cohorts | Oral Methylprednisolone
Intervention: Drug: Tablet Methylprednisolone (4 or 16 mg) | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 80 | |||
Original Estimated Enrollment | 100 | |||
Actual Study Completion Date | September 2010 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | India | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00929981 | |||
Other Study ID Numbers | B0121004 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | December 2018 |