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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01676844
Other study ID # UEC1112/65
Secondary ID 2012-003625-19
Status Not yet recruiting
Phase Phase 2
First received August 23, 2012
Last updated August 30, 2012
Start date February 2013
Est. completion date November 2013

Study information

Verified date August 2012
Source University of Strathclyde
Contact Helen Mactier, MB ChB
Phone 011441412115249
Email Helen.Mactier@ggc.scot.nhs.uk
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Oral thin film therapy (Potassium acid phosphate oral thin films)
Orally dissolving thin film. White, square oral thin film. 15 mm x 15 mm surface area. 1-2 mm film thickness. No markings. Place a single OTF on the tongue, inside cheek or palate and allow to dissolve.
Standard therapy (Potassium acid phosphate oral solution)
Each millilitre contains approximately 136mg Monobasic Potassium Phosphate Ph.Eur. (KH2PO4) equivalent to 1mmol Potassium (39mg) and 1mmol Phosphate (31mg Phosphorus). Manufacturer: Specials Products Ltd., Surrey, UK.

Locations

Country Name City State
United Kingdom Princess Royal Maternity Glasgow Strathclyde

Sponsors (1)

Lead Sponsor Collaborator
University of Strathclyde

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

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Outcome

Type Measure Description Time frame Safety issue
Primary Serum phosphate The aim of this research is to demonstrate that oral thin films (OTFs) containing potassium acid phosphate are equivalent to standard oral phosphate supplementation using an oral solution in the prevention of hypophosphataemia (low blood phosphorus). The primary outcome measure will be plasma phosphate. We will assume an equivalent therapeutic effect using OTFs if individual plasma levels for these babies are found to lie within an acceptable physiological range, and the difference between the means of the two groups (as determined by a statistical t-test) lies within 20% of the mean plasma level for the control group. Participants will be followed from birth until the end of the study period, approximately 6 weeks on average No
Secondary Age-appropriateness Secondary objectives will be in terms of age-appropriateness and general acceptability. A lack of any observable adverse effects e.g. choking, vomiting, diarrhoea, will indicate the safety of oral thin films in this age group. Acceptability will be assessed in terms of observed discomfort/distress e.g. grimacing, crying, associated with treatment administration and will be assessed using visual analogue scales. Participants will be followed from birth until the end of the study period, approximately 6 weeks on average Yes
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Recruiting NCT03889717 - Comparison of Two Different Doses of Vitamin D in Preterm Infants N/A
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