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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR DOPRAM


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All Clinical Trials for DOPRAM

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT04430790 ↗ Doxapram Therapy in Preterm Infants (DOXA Trial) Recruiting Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Phase 3 2020-06-15 Preterm infants often suffer from apnea of prematurity (AOP; a cessation of breathing) due to immaturity of the respiratory system. AOP can lead to oxygen shortage and a low heart rate which might harm the development of the newborn, especially the central nervous system. In order to prevent oxygen shortage, infants are treated with non-invasive respiratory support and caffeine. Despite these treatments, many preterm newborns still suffer from AOP and need invasive mechanical ventilation. Although this will result in complete resolution of AOP, invasive mechanical ventilation has the disadvantage of being a major risk of chronic lung disease and impaired neurodevelopmental outcome. Restrictive invasive ventilation is therefore advocated nowadays in preterm infants. Doxapram is a respiratory stimulant that has been administered off-label to treat AOP. Doxapram, as add-on treatment, seems to be effective in treating AOP and to prevent invasive mechanical ventilation. It is unclear if a preterm infant benefit from doxapram treatment on the longer term. This study compares doxapram to placebo and hypothesizes that doxapram will protect preterm infants from both invasive ventilation (and related lung disease) and AOP related oxygen shortage (and related impaired brain development).
NCT04430790 ↗ Doxapram Therapy in Preterm Infants (DOXA Trial) Recruiting Nederlands Neonataal Netwerk (N3), the Netherlands Phase 3 2020-06-15 Preterm infants often suffer from apnea of prematurity (AOP; a cessation of breathing) due to immaturity of the respiratory system. AOP can lead to oxygen shortage and a low heart rate which might harm the development of the newborn, especially the central nervous system. In order to prevent oxygen shortage, infants are treated with non-invasive respiratory support and caffeine. Despite these treatments, many preterm newborns still suffer from AOP and need invasive mechanical ventilation. Although this will result in complete resolution of AOP, invasive mechanical ventilation has the disadvantage of being a major risk of chronic lung disease and impaired neurodevelopmental outcome. Restrictive invasive ventilation is therefore advocated nowadays in preterm infants. Doxapram is a respiratory stimulant that has been administered off-label to treat AOP. Doxapram, as add-on treatment, seems to be effective in treating AOP and to prevent invasive mechanical ventilation. It is unclear if a preterm infant benefit from doxapram treatment on the longer term. This study compares doxapram to placebo and hypothesizes that doxapram will protect preterm infants from both invasive ventilation (and related lung disease) and AOP related oxygen shortage (and related impaired brain development).
NCT02171910 ↗ Doxapram as an Additive to Propofol Sedation in Sedation for ERCP Completed Helsinki University Central Hospital Phase 4 2016-10-01 Sedation is needed in order to complete endoscopic retrograde cholangiopancreatography (ERCP) to alleviate discomfort and pain during the procedure. This is usually achieved with use of opioids and/or sedative agents such as benzodiazepines or propofol. Traditionally benzodiazepines have been used but nowadays propofol is becoming the drug of choice for sedation during ERCP. The problem with propofol sedation is the fact that it may case cardiorespiratory depression and there is no antidote for this like there is for benzodiazepines. Cardiovascular depression can usually be easily counteracted with drugs that are used to raise blood pressure or heart rate during general anesthesia but respiratory depression remains a problem. The aim of this study is to try to counteract the respiratory depression caused by propofol sedation using an old respiratory stimulant doxapram as opposed to placebo using a double blind randomized protocol. The investigators hypothesis is that boluses and an infusion of doxapram will alleviate the respiratory depression caused by propofol sedation.
NCT00389909 ↗ Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants Completed Jean Michel Hascoet Phase 4 2006-11-01 Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.
NCT00389909 ↗ Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants Completed Maternite Regionale Universitaire Phase 4 2006-11-01 Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for DOPRAM

Condition Name

11110-0.100.10.20.30.40.50.60.70.80.911.1ApneaApnea of PrematurityHypoxiaPremature Infants[disabled in preview]
Condition Name for DOPRAM
Intervention Trials
Apnea 1
Apnea of Prematurity 1
Hypoxia 1
Premature Infants 1
[disabled in preview] 0
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Condition MeSH

11110-0.100.10.20.30.40.50.60.70.80.911.1Respiratory InsufficiencyPulmonary Valve InsufficiencyHypoxiaPremature Birth[disabled in preview]
Condition MeSH for DOPRAM
Intervention Trials
Respiratory Insufficiency 1
Pulmonary Valve Insufficiency 1
Hypoxia 1
Premature Birth 1
[disabled in preview] 0
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Clinical Trial Locations for DOPRAM

Trials by Country

+
Trials by Country for DOPRAM
Location Trials
Netherlands 7
Belgium 5
Finland 1
France 1
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Clinical Trial Progress for DOPRAM

Clinical Trial Phase

66.7%33.3%0-0.200.20.40.60.811.21.41.61.822.2Phase 4Phase 3[disabled in preview]
Clinical Trial Phase for DOPRAM
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
[disabled in preview] 0
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Clinical Trial Status

66.7%33.3%0-0.200.20.40.60.811.21.41.61.822.2CompletedRecruiting[disabled in preview]
Clinical Trial Status for DOPRAM
Clinical Trial Phase Trials
Completed 2
Recruiting 1
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Clinical Trial Sponsors for DOPRAM

Sponsor Name

trials000111112222Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Nederlands Neonataal Netwerk (N3), the NetherlandsUniversitaire Ziekenhuizen Leuven[disabled in preview]
Sponsor Name for DOPRAM
Sponsor Trials
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 1
Nederlands Neonataal Netwerk (N3), the Netherlands 1
Universitaire Ziekenhuizen Leuven 1
[disabled in preview] 2
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Sponsor Type

100.0%001234567Other[disabled in preview]
Sponsor Type for DOPRAM
Sponsor Trials
Other 7
[disabled in preview] 0
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Clinical Trials, Market Analysis, and Projections for Doxapram (DOPRAM)

Introduction

Doxapram, marketed as DOPRAM, is a respiratory stimulant used to treat respiratory depression and other conditions such as chronic obstructive pulmonary disease (COPD) associated with acute hypercapnia. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Use and Administration

Doxapram is administered intravenously and can be used in various clinical settings. For patients in a coma, it is given in repeated doses until the patient shows sustained arousal or reaches the maximum daily dose of 3 grams[1].

Clinical Trials Overview

Clinical trials involving doxapram are typically focused on its efficacy and safety in stimulating respiration and managing conditions like COPD.

Trial Design and Phases

Clinical trials for respiratory stimulants like doxapram often include multiple phases:

  • Phase I: Focuses on human pharmacology, including the first administration to humans and the assessment of pharmacokinetics and pharmacodynamics[4].
  • Phase II: Therapeutic exploratory trials that evaluate the efficacy and side effects of the drug.
  • Phase III: Therapeutic confirmatory trials involving a larger number of participants to confirm efficacy, monitor side effects, compare the drug to commonly used treatments, and collect information that will allow the drug to be used safely.

Recent and Ongoing Trials

While specific recent trials for doxapram may not be widely publicized, the general trend in clinical trials involves integrating omics technologies to improve drug efficacy and safety. Omics-based clinical trials, which include genomic, proteomic, and metabolomic data, are becoming increasingly important for personalized medicine and targeted therapeutic strategies[3].

Market Analysis

Global Market Trends

The global market for respiratory stimulants, including doxapram, is influenced by several factors:

  • Increasing Prevalence of Respiratory Diseases: Conditions like COPD and respiratory depression drive the demand for effective respiratory stimulants.
  • Advancements in Clinical Trials: The integration of omics technologies in clinical trials enhances the efficacy and safety of drugs, including doxapram[3].

Market Size and Forecast

While specific market reports for doxapram are not readily available, the broader market for respiratory drugs is significant. The global respiratory drugs market is expected to grow due to increasing respiratory diseases and advancements in treatment options.

Regional Analysis

  • North America: This region is expected to see significant growth due to the increasing preference for personalized medicine and the integration of omics data in clinical trials[3].
  • Asia Pacific: The region is anticipated to grow rapidly due to the large and diverse patient population and advancements in clinical research[3].

Market Projections

Forecast Period

From 2025 to 2031, the market for respiratory stimulants is expected to grow, driven by several key factors:

  • Technological Advancements: Integration of omics technologies and next-generation sequencing will continue to improve the efficacy and safety of drugs like doxapram[3].
  • Regulatory Support: Regulatory bodies are increasingly supporting the integration of omics data in clinical trials, which will drive market growth[3].

Drivers and Opportunities

  • Personalized Medicine: The rising focus on personalized medicine, which involves tailoring treatments to individual patients using metabolomic, proteomic, and genomic data, will drive the demand for drugs like doxapram[3].
  • Collaborative Initiatives: Increasing collaborative initiatives between the private sector, academic institutions, and government agencies will further drive market growth[3].

Restraints and Challenges

  • Regulatory and Reimbursement Challenges: Despite the growth potential, the market faces challenges related to regulatory approvals and reimbursement policies[3].
  • Limited Clinical Validation: The need for more clinical validation and integration into clinical practice remains a significant challenge[3].

Key Takeaways

  • Clinical Use: Doxapram is a critical respiratory stimulant used in various clinical settings.
  • Clinical Trials: The integration of omics technologies in clinical trials is enhancing the efficacy and safety of drugs like doxapram.
  • Market Growth: The market for respiratory stimulants is expected to grow driven by technological advancements, regulatory support, and the increasing focus on personalized medicine.
  • Regional Trends: North America and Asia Pacific are key regions driving market growth.

FAQs

What is Doxapram (DOPRAM) used for?

Doxapram is used as a respiratory stimulant to treat conditions such as respiratory depression and chronic obstructive pulmonary disease (COPD) associated with acute hypercapnia.

How is Doxapram administered?

Doxapram is administered intravenously and can be given in repeated doses or as an intermittent IV infusion, depending on the clinical scenario[1].

What are the key drivers of the market for respiratory stimulants like Doxapram?

The key drivers include technological advancements in clinical trials, increasing focus on personalized medicine, and regulatory support for the integration of omics data[3].

What are the challenges faced by the market for Doxapram?

The market faces challenges related to regulatory approvals, reimbursement policies, and the need for more clinical validation and integration into clinical practice[3].

How does the integration of omics technologies impact the market for Doxapram?

The integration of omics technologies improves the efficacy and safety of drugs like Doxapram by providing valuable insights into patient-specific responses at a molecular level, enabling better patient stratification and more targeted therapeutic strategies[3].

What is the forecasted growth for the respiratory stimulants market?

The market is expected to grow significantly from 2025 to 2031, driven by technological advancements, regulatory support, and the increasing focus on personalized medicine[3].

Sources

  1. DOPRAM Injection - accessdata.fda.gov
  2. Global Doxapram Hydrochloride Market Report 2024 Edition - cognitivemarketresearch.com
  3. Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034 - biospace.com
  4. EU Clinical Trials Register - clinicaltrialsregister.eu

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