A Phase IV Clinical Trial to Study the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis
NCT ID: NCT01373567
Last Updated: 2012-11-22
Study Results
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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COMPLETED
PHASE4
298 participants
INTERVENTIONAL
2010-12-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TINEFCON
Tablets of 700 mg.
TINEFCON
Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.
Interventions
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TINEFCON
Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.
Eligibility Criteria
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Inclusion Criteria
* Subject who understand and willing to sign informed consent document before start of any study specific assessment
Exclusion Criteria
* Subject with active infection, acute or chronic due to bacteria, viruses, fungi or parasites (most notably tuberculosis, and chronic hepatitis B)
* Subject with heart failure (New York Heart Association class III or IV)
* Subject with demyelinating disease
* Subject with solid cancer or hematologic malignancy diagnosed within last 5 years with a potential for progression
* Women of childbearing potential \[defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)\] and men, not agreeing to use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) after signing an informed consent document (ICD), during the duration of study participation and for at least 4 week after withdrawal from the study, unless they are surgically sterilized
* Subject with situations associated with a high risk of infection such as latent untreated tuberculosis, joint prosthesis infection within last 12 months, indwelling urinary catheter, uncontrolled diabetes, chronic obstructive pulmonary disease, skin ulcer
* Subject with known premalignant lesions (such as polyps in the colon or urinary bladder, cervical dysplasia and myelodysplasia)
* Subject known to be seropositive and/or clinically suspected to have the human immunodeficiency virus infection
* Subject with any condition that might make it difficult for the subject to participate in the study, at the discretion of the Investigator.
18 Years
ALL
No
Sponsors
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Piramal Enterprises Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Sharmila Patil
Role: PRINCIPAL_INVESTIGATOR
D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul, Navi Mumbai
Dr. Jerajani
Role: PRINCIPAL_INVESTIGATOR
Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion, Mumbai-400022 India
Dr. Saple
Role: PRINCIPAL_INVESTIGATOR
Dr. Saple's clinic, 88, 3rd Lane, Hindu Colony, Near Bhagini Samaj, Dadar (East), Mumbai-400014
Dr.Ranjan Rawal
Role: PRINCIPAL_INVESTIGATOR
Sheth VS General Hospital, Department of Dermatology, Ellis Bridge, Ahmedabad -380006, Gujrat, India
Dr Sudhakar Grandhi
Role: PRINCIPAL_INVESTIGATOR
Medipoint Hospitals Pvt. Ltd.,Pentagon Research Pvt. Ltd, 241/1, New DP Road, Aundh, Pune-411007, Maharashtra
Dr Sushil Pande
Role: PRINCIPAL_INVESTIGATOR
NKP Salve Institute and Lata Mangeshkar Hospital,Nagpur
Dr. Torsekar
Role: PRINCIPAL_INVESTIGATOR
Rajiv Gandhi Medical College & CSMH,Department of Dermatology, Kalwa, Thane
Dr. C.R. Srinivas
Role: PRINCIPAL_INVESTIGATOR
PSG Hospital,Department of Skin & STD,Avinashi Road, Peelamedu, Coimbatore, Tamilnadu-641004
Dr. DVS Pratap
Role: PRINCIPAL_INVESTIGATOR
Durgabai Deshmukh Hospital & Research Center, Andhramahila Sabha Road, Vidyanagar, University Road,Hyderabad
Dr. Aruna Samarth
Role: PRINCIPAL_INVESTIGATOR
Sai Skin Care Clinic, H.No.:2-1-409, Nallakunta, O.U.Road, Hyderabad
Dr. Kanwar
Role: PRINCIPAL_INVESTIGATOR
Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology,Sector-12-Chandigarh
Dr. Meetesh Agarwal
Role: PRINCIPAL_INVESTIGATOR
178/DH Sector, Scheme No. 74, Vijaynagar, Indore 452 2010
Dr. Kailash Bhatia
Role: PRINCIPAL_INVESTIGATOR
Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar, Indore
Dr. Parmjit Singh Walia
Role: PRINCIPAL_INVESTIGATOR
DR WALIA'S SKIN & LASER CLINIC, SCF - 30, PHASE
Dr. Bhavesh Swarnkar
Role: PRINCIPAL_INVESTIGATOR
Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar,Indore
Dr. Sandesh Gupta
Role: PRINCIPAL_INVESTIGATOR
Skin & Laser Center,F-12/10 Krishna Nagar, New Delhi
Dr. Puneet Goyal
Role: PRINCIPAL_INVESTIGATOR
Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg, Mansarovar, Jaipur
Dr.Rizwan Haq
Role: PRINCIPAL_INVESTIGATOR
Radiance Skin Care Clinic, Opp. Muslim Library,Tekdi Road, Sadar, Nagpur
Dr Vikrant Saoji
Role: PRINCIPAL_INVESTIGATOR
Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth, Nagpur
Dr.B. Leelavathy
Role: PRINCIPAL_INVESTIGATOR
M.S. Diabetes and Shirdi Skin care centre 6/1, 80 Feet Road, Opp. Krishna Sagar Hotel, Indiranagar, Bangalore
Dr Titarmare
Role: PRINCIPAL_INVESTIGATOR
Skin Care Clinic, Consultant Dermatologist &Venerologist,Akshay Towers(Basement), Umrer Road,Sakkardhara Square, Nagpur
Dr Shatrughan Sahay
Role: PRINCIPAL_INVESTIGATOR
Sri Skin Care & Laser Clinic,Netaji Subash Chandra Bose Complex, Tulsidas Marg (Opp. Charak Pathalogy) Chowk-Lucknow
Locations
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Durgabai Deshmukh Hospital & Research Center
Hyderabad, Andhra Pradesh, India
Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology
Chandigarh, Chandigarh, India
Sheth VS General Hospital, Department of Dermatology
Ahmedabad, Gujarat, India
M.S. Diabetes and Shirdi Skin care centre
Bangalore, Karnataka, India
Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar
Indore, Madhtya Pradesh, India
Scheme No. 74, , Vijaynagar, ,
Indore, Madhya Pradesh, India
Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar
Indore, Madhya Pradesh, India
Sai Skin Care Clinic
Hyderabad, Maharashtra, India
Dr. Saple's clinic
Mumbai, Maharashtra, India
Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion
Mumbai, Maharashtra, India
Seth GS Medical College &KEM Hospital,Department of Dermatology
Mumbai, Maharashtra, India
Dr.Vikrant Saoji,27, Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth
Nagpur, Maharashtra, India
NKP Salve Institute and Lata Mangeshkar Hospital
Nagpur, Maharashtra, India
Radiance Skin Care Clinic
Nagpur, Maharashtra, India
Skin Care Clinic, Consultant Dermatologist &Venerologist
Nagpur, Maharashtra, India
Medipoint Hospitals Pvt. Ltd
Pune, Maharashtra, India
Rajiv Gandhi Medical College
Thāne, Maharashtra, India
Skin & Laser Center,F-12/10 Krishna Nagar,
New Delhi, New Delhi, India
Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar
Mohali, Punjab, India
Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg
Jaipur, Rajasthan, India
PSG Hospital,Department of Skin & STD
Coimbatore, Tamil Nadu, India
Sri Skin Care & Laser Clinic
Lucknow, Uttar Pradesh, India
D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul
Navi Mumbai, , India
Countries
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Other Identifiers
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TINEFCON/49/10
Identifier Type: -
Identifier Source: org_study_id