Clinical trials: Documentation
Ankylosing Spondylitis
Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)
The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.
- Trial name
- NCT01079182
- Volunteers
- 4,681 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Anemia
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)
This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting…
- Trial name
- NCT01417377
- Testing
- Mircera
- Where
- 6 sites in Pakistan
- Volunteers
- 22 people
- Sponsor
- Hoffmann-La Roche
Prostatic Neoplasm
Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer
Document treatment patterns and evaluate LUCRIN / LUCRIN-TRIDEPOT® (Leuprolide) and alternative therapeutic approaches to the treatment of advanced prostate cancer during normal clinical practice and in accordance with the terms…
- Trial name
- NCT01081873
- Testing
- leuprolide (Lucrin/Lucrin-Tri-depot)
- Where
- 135 sites in Belgium, Luxembourg
- Volunteers
- 2,717 people
- Sponsor
- Abbott
Multiple Sclerosis
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis
The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse.
- Trial name
- NCT00803049
- Testing
- Teriflunomide (HMR1726)
- Where
- 116 sites in United States, Austria and 19 more
- Volunteers
- 742 people
- Sponsor
- Sanofi
Diabetic Foot Ulcers (DFU), Venous Stasis Ulcers (VSU)
OASIS Wound Matrix (Oasis) Mechanism of Action
OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.
- Trial name
- NCT00570141
- Testing
- OASIS Wound Matrix
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Healthpoint
Inherited Epidermolysis Bullosa
Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
The purpose of this study was to compare intra-individually the reepithelialization of skin lesion(s) in inherited Epidermolysis bullosa (either 1 wound ≥10 cm2 and ≤200 cm2 in size divided in 2 equal halves or 2 comparable…
- Trial name
- NCT01294241
- Testing
- Oleogel-S10, Mepilex® soft silicone faced polyurethane foam dressing
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Birken AG
Hypercholesterolemia
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
Primary Objective: To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to…
- Trial name
- NCT02476006
- Testing
- ALIROCUMAB SAR236553 (REGN727), ezetimibe, atorvastatin
- Where
- 153 sites in Austria, Belgium and 14 more
- Volunteers
- 998 people
- Sponsor
- Sanofi
Hemophilia A
Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously…
- Trial name
- NCT02962765
- Where
- 39 sites in United States, Argentina and 11 more
- Volunteers
- 80 people
- Sponsor
- Octapharma
Hyperlipidemia
Compliance With Treatment For Patients With Hyperlipidemia
It is a prospective observational study. Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin.
- Trial name
- COLL (NCT00828945)
- Testing
- Lipid Self Test
- Where
- 17 sites in Sweden
- Volunteers
- 259 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Functional Constipation
Prucalopride in Pediatric Subjects With Functional Constipation
To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years.
- Trial name
- FC (NCT01330381)
- Testing
- prucalopride, PEG 4000
- Where
- Netherlands
- Volunteers
- 215 people
- Sponsor
- Shire
Constipation
A Study of Prucalopride For Functional Constipation in Children and Teenagers
Functional constipation is a condition when it is very hard to pass a stool that is not due to any other health problem or to medicines being taken. This condition is more common in children and teenagers.
- Trial name
- NCT04759833
- Testing
- Prucalopride
- Where
- 41 sites in United States
- Volunteers
- 175 people
- Sponsor
- Takeda
Stoma
Coloplast DialogueStudy
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
- Trial name
- NCT00626821
- Testing
- SenSura
- Where
- United States
- Volunteers
- 3,017 people
- Sponsor
- Coloplast A/S
Anemia
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia.
- Trial name
- NCT00090753
- Testing
- Methoxy Polyethylene Glycol-Epoetin Beta, Epoetin alfa, Epoetin beta
- Where
- 249 sites in United States, Australia and 25 more
- Volunteers
- 1,228 people
- Sponsor
- Hoffmann-La Roche
Chronic Myelogenous Leukemia, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Rollover Study of BMS-354825 in Patients With CML and Ph+ALL
To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant…
- Trial name
- NCT01030718
- Testing
- dasatinib
- Volunteers
- 54 people
- Sponsor
- Bristol-Myers Squibb
Rheumatoid Arthritis
Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis
The AGIL study was designed to evaluate the effectiveness and safety of adalimumab over 5 years in routine daily clinical practice in Germany, with a focus on the impact of therapy on employment-related outcomes.
- Trial name
- AGIL (NCT01076205)
- Volunteers
- 7,229 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Rheumatoid Arthritis
Special Investigation in Patients With Rheumatoid Arthritis (Working Productivity Activity Impairment)
This is a single-arm, multi-center, prospective cohort study (post-marketing observational study). The observation period for each participant is 48 weeks.
- Trial name
- NCT01346488
- Volunteers
- 2,088 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Psoriatic Arthritis
Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice
This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.
- Trial name
- NCT01111240
- Where
- 509 sites in Germany
- Volunteers
- 4,635 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Breast Cancer
An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer
This observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer.
- Trial name
- XEPAD (NCT01725386)
- Testing
- Capecitabine
- Where
- 15 sites in Pakistan
- Volunteers
- 274 people
- Sponsor
- Hoffmann-La Roche
Cataract
A Study of B + L Ophthalmic Viscosurgical Device (OVD) CVisc50
The objective of the study is to evaluate the safety and effectiveness of the Bausch \& Lomb CVisc50 cohesive OVD compared to the Alcon ProVisc® cohesive OVD when used in cataract surgery.
- Trial name
- NCT04192630
- Testing
- CVisc50 OVD, ProVisc OVD, Cataract Surgery
- Where
- 22 sites in United States
- Volunteers
- 390 people
- Sponsor
- Bausch & Lomb Incorporated
Multiple Sclerosis
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with multiple sclerosis [MS] with relapses.
- Trial name
- NCT00811395
- Testing
- Teriflunomide, Interferon-β [IFN-β], Glatiramer Acetate [GA]
- Where
- 7 sites in United States, Austria and 5 more
- Volunteers
- 182 people
- Sponsor
- Sanofi