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Last Updated: March 14, 2025

CLINICAL TRIALS PROFILE FOR TRIAMINIC-12


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All Clinical Trials for TRIAMINIC-12

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01676844 ↗ Investigating a New Way of Giving Medicine to Newborn and Preterm Babies Unknown status University of Strathclyde Phase 2 2013-02-01 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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 1 of 1 entries

Clinical Trial Conditions for TRIAMINIC-12

Condition Name

110-0.100.10.20.30.40.50.60.70.80.911.1HypophosphataemiaOsteopenia of Prematurity[disabled in preview]
Condition Name for TRIAMINIC-12
Intervention Trials
Hypophosphataemia 1
Osteopenia of Prematurity 1
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Condition MeSH

1110-0.100.10.20.30.40.50.60.70.80.911.1Premature BirthHypophosphatemiaBone Diseases, Metabolic[disabled in preview]
Condition MeSH for TRIAMINIC-12
Intervention Trials
Premature Birth 1
Hypophosphatemia 1
Bone Diseases, Metabolic 1
[disabled in preview] 0
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Clinical Trial Locations for TRIAMINIC-12

Trials by Country

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Trials by Country for TRIAMINIC-12
Location Trials
United Kingdom 1
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Clinical Trial Progress for TRIAMINIC-12

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 2[disabled in preview]
Clinical Trial Phase for TRIAMINIC-12
Clinical Trial Phase Trials
Phase 2 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Unknown status[disabled in preview]
Clinical Trial Status for TRIAMINIC-12
Clinical Trial Phase Trials
Unknown status 1
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Clinical Trial Sponsors for TRIAMINIC-12

Sponsor Name

trials000001111111University of Strathclyde[disabled in preview]
Sponsor Name for TRIAMINIC-12
Sponsor Trials
University of Strathclyde 1
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Sponsor Type

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Other[disabled in preview]
Sponsor Type for TRIAMINIC-12
Sponsor Trials
Other 1
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Triaminic: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Triaminic is a well-known over-the-counter (OTC) medication brand, particularly popular for its cough and cold remedies. This article will delve into the clinical trials, market analysis, and future projections for Triaminic products, especially focusing on the Triaminic-12 range.

Clinical Trials and Safety Profile

Adverse Reactions and Safety

Triaminic products, such as Triaminic Cough & Congestion, contain active ingredients like dextromethorphan and guaifenesin. Clinical data and safety profiles indicate that these medications can cause a range of adverse reactions, from mild to severe.

  • Mild Adverse Reactions: Common side effects include nausea, drowsiness, dizziness, headache, and irritability[1][4].
  • Moderate to Severe Adverse Reactions: These can include respiratory depression, dysarthria, confusion, hallucinations, and nephrolithiasis. Severe reactions such as seizures and serotonin syndrome are also possible, although their incidence is not well-documented[1].

Dosage and Administration

Clinical trials and dosage guidelines emphasize the importance of proper administration to minimize adverse effects. For example, Triaminic Long Acting Cough is not recommended for children under 4 years old, and the dosage varies by age group (5mL for 4-6 years, 10mL for 6-12 years, repeated every 6-8 hours as needed)[4].

Market Analysis

Product Innovations

Novartis Consumer Health, Inc., the manufacturer of Triaminic, has been at the forefront of innovation in the OTC cough and cold treatment category. The introduction of Triaminic Thin Strips in 2004 marked a significant milestone, offering a convenient, portable, and accurate dosing method that enhanced consumer compliance. These thin strips, available in various flavors, melt on the tongue and do not require water, making them highly palatable and easy to use, especially for children[2].

Consumer Demand and Market Growth

The launch of Triaminic Thin Strips was met with high consumer demand, driven by the product's convenience, ease of use, and portability. Market research indicated that over 90% of consumers would recommend these products to friends, highlighting their satisfaction with the new delivery mechanism. This innovation contributed to a 17.6% growth in dollar sales in the cough and cold treatment category during the 2002-2004 seasons[2].

Competitive Landscape

The OTC cough and cold market is highly competitive, with several brands vying for market share. However, Triaminic's innovative products and strong marketing support have helped it maintain a significant presence. The brand's ability to reduce development time and bring new products to market quickly has been a key factor in its success[2].

Market Projections

Future Trends and Innovations

The OTC market is expected to continue growing, driven by consumer demand for convenient, effective, and innovative products. Triaminic is likely to benefit from this trend by continuing to innovate and expand its product line.

  • Advanced Delivery Mechanisms: The success of Triaminic Thin Strips suggests that future products will focus on similar convenient delivery mechanisms, enhancing compliance and user experience.
  • Expanded Product Lines: Triaminic may expand its product range to include more targeted treatments, such as specific formulations for different age groups or symptom profiles.

Consumer Preferences

Consumers are increasingly looking for products that offer better portability, ease of dosing, and overall convenience. Triaminic's focus on these attributes is expected to continue driving its market share. The brand's proprietary taste technology, which effectively masks the negative taste of active ingredients, is another factor that will likely contribute to its future success[2].

Key Takeaways

  • Clinical Safety: Triaminic products have a well-documented safety profile, with guidelines for proper dosage to minimize adverse reactions.
  • Market Innovation: The introduction of innovative products like Triaminic Thin Strips has been a significant factor in the brand's market success.
  • Consumer Demand: High consumer demand and satisfaction with Triaminic products are expected to drive continued market growth.
  • Future Trends: The brand is likely to continue innovating in delivery mechanisms and expanding its product lines to meet evolving consumer preferences.

FAQs

Q: What are the common side effects of Triaminic Cough & Congestion?

A: Common side effects include nausea, drowsiness, dizziness, headache, and irritability. More severe reactions can include respiratory depression, dysarthria, and hallucinations[1].

Q: Who is the target audience for Triaminic Thin Strips?

A: Triaminic Thin Strips are available for both adults and children. For children, the product is designed for those aged 6-12 years, while adults can use the Theraflu Thin Strips version[2].

Q: What is the recommended dosage for Triaminic Long Acting Cough?

A: The dosage varies by age: children under 4 years should not use it, 4-6 years old should take 5mL, and 6-12 years old should take 10mL, repeated every 6-8 hours as needed[4].

Q: How have innovations like Triaminic Thin Strips impacted the market?

A: Innovations like Triaminic Thin Strips have significantly increased consumer compliance and satisfaction, contributing to a 17.6% growth in dollar sales in the cough and cold treatment category[2].

Q: What are the future trends expected in the OTC cough and cold market?

A: Future trends are expected to focus on convenient delivery mechanisms, expanded product lines, and enhanced consumer experience through advanced taste technology and portability[2].

Sources

  1. PDR.Net - Triaminic Cough & Congestion - Drug Summary
  2. Biospace - Novartis Consumer Health, Inc. Launches First-To-Market Medicine in Thin Film Form
  3. GSK - Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations
  4. EMPR - Triaminic Long Acting Cough Prescription & Dosage Information
  5. Drugs.com - TRIAMINIC Childrens Night Time Cold and Cough

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