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Last Updated: January 5, 2025

CLINICAL TRIALS PROFILE FOR SECOBARBITAL SODIUM


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All Clinical Trials for SECOBARBITAL SODIUM

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Federal University of São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
>Trial ID>Title>Status>Phase>Start Date>Summary
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Clinical Trial Conditions for SECOBARBITAL SODIUM

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Atrial Fibrillation[disabled in preview]
Condition Name for SECOBARBITAL SODIUM
Intervention Trials
Atrial Fibrillation 1
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Atrial Fibrillation[disabled in preview]
Condition MeSH for SECOBARBITAL SODIUM
Intervention Trials
Atrial Fibrillation 1
[disabled in preview] 0
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Clinical Trial Locations for SECOBARBITAL SODIUM

Trials by Country

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Trials by Country for SECOBARBITAL SODIUM
Location Trials
Brazil 1
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Clinical Trial Progress for SECOBARBITAL SODIUM

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4[disabled in preview]
Clinical Trial Phase for SECOBARBITAL SODIUM
Clinical Trial Phase Trials
Phase 4 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Completed[disabled in preview]
Clinical Trial Status for SECOBARBITAL SODIUM
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for SECOBARBITAL SODIUM

Sponsor Name

trials000001111111Fundação de Amparo à Pesquisa do Estado de São PauloFederal University of São Paulo[disabled in preview]
Sponsor Name for SECOBARBITAL SODIUM
Sponsor Trials
Fundação de Amparo à Pesquisa do Estado de São Paulo 1
Federal University of São Paulo 1
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2Other[disabled in preview]
Sponsor Type for SECOBARBITAL SODIUM
Sponsor Trials
Other 2
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SECOBARBITAL SODIUM Market Analysis and Financial Projection

Secobarbital Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Secobarbital sodium, marketed under the brand name Seconal, is a barbiturate used primarily as a sedative and hypnotic. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Short-Term Use

Clinical trials have shown that secobarbital sodium is effective for short-term use in treating insomnia. Studies have demonstrated improvements in both sleep induction and sleep maintenance with short-term administration, up to 3 nights. For instance, a study published on PubMed found that secobarbital reduced total wake time by 43% below baseline levels during short-term use[3].

Intermediate-Term Use

However, the efficacy of secobarbital sodium diminishes with intermediate-term use. The same study indicated that with 2 weeks of administration, the total wake time was only decreased by 14%, which was not statistically significant. This suggests that the drug is of limited value for patients requiring nightly medication beyond one week[3].

Preanesthetic Use

Secobarbital sodium is also used as a preanesthetic sedative. Clinical guidelines recommend dosages of 200-300mg for adults 1-2 hours before surgery, with reduced doses for elderly, debilitated patients, or those with hepatic or renal impairment[1].

Market Analysis

Current Market Landscape

The global market for secobarbital sodium salt is analyzed in terms of manufacturing methods, technology development, market trends, and distribution policies. The market report from 2016 highlights the segmentation of the market and the key players involved in the production and distribution of secobarbital sodium salt[5].

Demand and Supply

The demand for secobarbital sodium is influenced by its use in treating insomnia and as a preanesthetic agent. However, due to its limited efficacy beyond short-term use and the availability of alternative treatments, the demand has been relatively stable rather than growing.

Competitive Landscape

The barbiturate market, including secobarbital sodium, faces competition from other classes of sedatives and hypnotics, such as benzodiazepines and non-benzodiazepine hypnotics. The competitive landscape is further complicated by the strict regulatory environment surrounding barbiturates due to their potential for abuse and dependence[4].

Market Projections

Future Trends

Given the limited long-term efficacy of secobarbital sodium for insomnia and the availability of safer, more effective alternatives, the market for this drug is expected to remain stable or decline slightly. The use of secobarbital sodium as a preanesthetic agent may continue, but this is a niche market and not a significant driver of overall demand.

Regulatory Environment

The regulatory environment plays a crucial role in the market projections for secobarbital sodium. As a Schedule II controlled substance, its use is strictly monitored, and any changes in regulatory policies could impact its market dynamics[1].

Drug Interactions and Safety

Clinical Considerations

Secobarbital sodium interacts with several other medications, notably phenytoin, sodium valproate, and valproic acid. These interactions can affect the serum levels of secobarbital sodium, necessitating close monitoring and dosage adjustments[4].

Contraindications

The drug is contraindicated in patients with manifest or latent porphyria, marked hepatic impairment, and respiratory diseases where dyspnea or obstruction is evident. These contraindications further limit its market potential[1].

Patient Counseling and Education

Safe Use Practices

Patients prescribed secobarbital sodium need to be educated on its safe use practices, including the risks of dependence and the importance of adhering to the prescribed dosage and duration of treatment. This education is crucial in minimizing the potential for abuse and ensuring the drug is used effectively[1].

Key Takeaways

  • Efficacy: Secobarbital sodium is effective for short-term treatment of insomnia and as a preanesthetic sedative but loses efficacy with intermediate-term use.
  • Market: The market for secobarbital sodium is stable but faces competition from other sedatives and hypnotics.
  • Regulations: Strict regulatory oversight due to its potential for abuse and dependence.
  • Interactions: Significant drug interactions require close monitoring and dosage adjustments.
  • Contraindications: Limited use due to contraindications in certain medical conditions.

FAQs

What is the primary use of secobarbital sodium?

Secobarbital sodium is primarily used for the short-term treatment of insomnia and as a preanesthetic sedative.

How effective is secobarbital sodium for long-term insomnia treatment?

Secobarbital sodium loses much of its effectiveness for insomnia treatment beyond one week, making it of limited value for long-term use.

What are the common contraindications for secobarbital sodium?

Secobarbital sodium is contraindicated in patients with manifest or latent porphyria, marked hepatic impairment, and respiratory diseases where dyspnea or obstruction is evident.

How does secobarbital sodium interact with other medications?

Secobarbital sodium can interact with medications like phenytoin, sodium valproate, and valproic acid, requiring close monitoring and potential dosage adjustments.

What is the regulatory classification of secobarbital sodium?

Secobarbital sodium is classified as a Schedule II controlled substance due to its potential for abuse and dependence.

Sources

  1. eMPR.com: Seconal Sodium Prescription & Dosage Information.
  2. Drug Central: Secobarbital.
  3. PubMed: Effectiveness of intermediate-term use of secobarbital.
  4. RxList: Seconal Sodium (Secobarbital Sodium Capsules).
  5. Business Wire: Global Secobarbital Sodium Salt (CAS 309-43-3) Market Report 2016 - Research and Markets.

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