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Generated: September 20, 2017

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
ZUPLENZ

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT01676844 Investigating a New Way of Giving Medicine to Newborn and Preterm BabiesUnknown statusUniversity of StrathclydePhase 2 There is a deficit in the number of 'age-appropriate' formulations available for the delivery of medicines to children. Liquid preparations are considered the 'gold standard' for delivering medicines to children however many of these are formulated using ingredients which can be toxic to children (e.g. preservatives, alcohols), particularly to neonatal babies (< 4 weeks old) who do not possess the metabolic processes and mature organ function of older children or adults. Rapidly dissolving oral thin films (OTFs) dissolve quickly in the saliva, releasing the active ingredient(s) without the need for chewing or water, making them ideally suited to patients who find it difficult to swallow other oral dosage forms such as tablets or capsules. The aim of this study is to demonstrate that OTFs can offer a safe and effective alternative for oral administration of phosphate supplements to neonatal infants for the treatment of hypophosphataemia and osteopenia of prematurity. It is hypothesised that this treatment will be equal to standard therapy using an oral solution. Babies born before 32 weeks gestational age are routinely supplemented with oral phosphate as soon as they have been established on oral feeds in order to prevent bone disorders such as osteopenia. Babies recruited to this study will be given phosphate supplementation as per NHS Greater Glasgow and Clyde guidelines. This single-centre cross-over study will take place in the intensive care and special care baby units at the Princess Royal Maternity in Glasgow. The investigators aim to recruit 20-30 babies and will use blood phosphate levels (obtained from routine sampling only) to evaluate treatment effect. Babies will be randomised to receive either OTFs or oral solution of potassium acid phosphate for 2 weeks followed by 2 weeks of the other therapy. The investigators hypothesise that OTF treatment will be equivalent to standard oral solution.
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Conditions

Condition Name

Condition Name for ZUPLENZ
Intervention Trials
Hypophosphataemia 1
Osteopenia of Prematurity 1
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Condition MeSH

Condition MeSH for ZUPLENZ
Intervention Trials
Bone Diseases, Metabolic 1
Premature Birth 1
Hypophosphatemia 1
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Trial Locations

Trials by Country

Trials by Country for ZUPLENZ
Location Trials
United Kingdom 1
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for ZUPLENZ
Clinical Trial Phase Trials
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for ZUPLENZ
Clinical Trial Phase Trials
Unknown status 1
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for ZUPLENZ
Sponsor Trials
University of Strathclyde 1
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Sponsor Type

Sponsor Type for ZUPLENZ
Sponsor Trials
Other 1
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Serving 500+ biopharmaceutical companies globally:

US Army
Moodys
Deloitte
US Department of Justice
Mallinckrodt
Harvard Business School
Farmers Insurance
Chubb
Chinese Patent Office
Dow

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