CLINICAL TRIALS PROFILE FOR ROBINUL FORTE

All Clinical Trials for Robinul Forte

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00579085 ↗	Double Blind Placebo Controlled Study of Outpatient Intravenous Ketamine for the Treatment of CRPS	Completed	Drexel University College of Medicine	Phase 2	2006-09-01	Complex Regional Pain Syndrome is a debilitating and extremely difficult to treat condition. There is a large body of evidence demonstrating the therapeutic value of N-methyl-D-aspartate (NMDA)-receptor antagonists in CRPS. The NMDA antagonist ketamine has been shown to be effective in the treatment of CRPS, resulting in complete remission of the disease in some patients. The purpose of this study is to evaluate intravenous outpatient infusion of sub-anesthetic doses of ketamine for the treatment of CRPS. A thorough evaluation of this procedure, providing information into the degree of relief and which of the constellation of RSD symptoms are best alleviated by this procedure would result in the optimization of this therapy for the treatment of CRPS.
NCT01191398 ↗	Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation	Completed	Craig J. Huang	N/A	2010-06-01	The purpose of this study is to determine if the antisialagogues (anti-salivary agents), Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating patients with Ketamine for procedural sedation in the emergency department or abscess clinic. The investigators will measure salivary flow rate by collecting oral secretions by oral suctioning over a 30 minute time period starting with the administration of Ketamine. The investigators hypothesize that patients who receive either atropine or glycopyrrolate will have fewer oral secretions than patients who receive placebo.
NCT02872935 ↗	Minimizing Nausea and Vomiting During Spinals for CS	Terminated	Kokila N Thenuwara	Phase 4	2015-05-15	In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.
NCT02872935 ↗	Minimizing Nausea and Vomiting During Spinals for CS	Terminated	University of Iowa	Phase 4	2015-05-15	In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.
NCT03513757 ↗	Dexmedetomidine and Propofol for Pediatric MRI Sedation	Completed	Medical College of Wisconsin	Phase 4	2018-03-04	The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol). The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. The investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, the investigators will administer whatever is necessary. At the end of the study, the investigators will have an observer record the time it takes for participants to spontaneously open eyes , to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that the investigators find out from participants about changes in behavior, or if eating or sleeping habits were unusual following completion of the study. For that reason, the investigators will call participants in a day or so following the MRI scan. The investigators expect to recruit 40 children between the ages of 12 and 72 months for the study and hope to have the study completed in December 2018.
NCT03735563 ↗	Premedication for Less Invasive Surfactant Administration	Recruiting	Oulu University Hospital	Phase 4	2019-02-11	Early respiratory management of preterm infants immediately after birth should be as gentle as possible. With this so-called developmental approach, unnecessary invasive methods can be avoided or at least postponed. This kind of "soft landing" allows cardiorespiratory transition with fewer adverse outcomes. Less invasive surfactant administration (LISA) is a technique that involves delivery of surfactant to a spontaneously breathing infant through a thin catheter. This technique minimizes the risk for neonatal lung injury caused by positive pressure ventilation. LISA is nowadays widely used in neonatal intensive care units (NICU). Although less invasive, newborns exposed to this procedure need premedication prior the procedure. There is no consensus, which drug would be the optimal premedication for LISA and the research on this topic is lacking. An ideal premedication would treat the procedural pain without suppressing the infant's own breathing. The sedation and analgesia should start fast but the effect should be short-acting with as few adverse effects as possible. The aim of this randomized, controlled trial (RCT) is to evaluate the feasibility, efficacy and safety of LISA protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol.
NCT03735563 ↗	Premedication for Less Invasive Surfactant Administration	Recruiting	University of Oulu	Phase 4	2019-02-11	Early respiratory management of preterm infants immediately after birth should be as gentle as possible. With this so-called developmental approach, unnecessary invasive methods can be avoided or at least postponed. This kind of "soft landing" allows cardiorespiratory transition with fewer adverse outcomes. Less invasive surfactant administration (LISA) is a technique that involves delivery of surfactant to a spontaneously breathing infant through a thin catheter. This technique minimizes the risk for neonatal lung injury caused by positive pressure ventilation. LISA is nowadays widely used in neonatal intensive care units (NICU). Although less invasive, newborns exposed to this procedure need premedication prior the procedure. There is no consensus, which drug would be the optimal premedication for LISA and the research on this topic is lacking. An ideal premedication would treat the procedural pain without suppressing the infant's own breathing. The sedation and analgesia should start fast but the effect should be short-acting with as few adverse effects as possible. The aim of this randomized, controlled trial (RCT) is to evaluate the feasibility, efficacy and safety of LISA protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol.

Clinical Trial Conditions for Robinul Forte

Condition Name

Condition Name for Robinul Forte
Intervention	Trials
Nausea	1
Neurofibromatoses	1
Seizure Disorder	1
Sialorrhea	1

Condition MeSH

Condition MeSH for Robinul Forte
Intervention	Trials
Reflex Sympathetic Dystrophy	1
Headache	1
Respiratory Distress Syndrome	1
Complex Regional Pain Syndromes	1

Clinical Trial Locations for Robinul Forte

Trials by Country

Trials by Country for Robinul Forte
Location	Trials
United States	4
Canada	1
Finland	1

Trials by US State

Trials by US State for Robinul Forte
Location	Trials
Wisconsin	1
Iowa	1
Texas	1
Pennsylvania	1

Clinical Trial Progress for Robinul Forte

Clinical Trial Phase

Clinical Trial Phase for Robinul Forte
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	1
N/A	2

Clinical Trial Status

Clinical Trial Status for Robinul Forte
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Unknown status	1

Clinical Trial Sponsors for Robinul Forte

Sponsor Name

Sponsor Name for Robinul Forte
Sponsor	Trials
Drexel University College of Medicine	1
Craig J. Huang	1
Kokila N Thenuwara	1

Sponsor Type

Sponsor Type for Robinul Forte
Sponsor	Trials
Other	9

Clinical Trials, Market Analysis, and Projections for Robinul Forte

Introduction

Robinul Forte, a brand name for the anticholinergic medication glycopyrrolate, has been a staple in medical practice for decades, particularly for its use in reducing secretions and treating various conditions. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy and Safety Studies

Clinical trials for glycopyrrolate, the active ingredient in Robinul Forte, have been extensive. The FDA-approved application for glycopyrrolate oral solution included three key studies: two efficacy and safety studies, and one pharmacokinetic study. The pivotal efficacy trial (FH-00-01) and an open-label, long-term safety study (SC-GLYCO-06-01) were crucial in evaluating the drug's efficacy and safety in pediatric patients with cerebral palsy or other neurologic conditions[1].

Pharmacokinetic Studies

The pharmacokinetic study (FH-00-02) was designed to compare the bioavailability of the oral solution to the marketed tablet product under fasted conditions and to assess the bioavailability under fed conditions. This study revealed lower bioavailability of the oral solution compared to the tablet, though no clear explanation was provided for this difference[1].

Safety Monitoring

Safety monitoring in these trials highlighted anticholinergic adverse events such as constipation, urinary retention, and flushing, which were more common in the treatment group than in the placebo group. However, these adverse events were generally not serious, and the long-term safety study did not show an increasing incidence of new adverse events over time[5].

Market Analysis

Generic Availability

Robinul Forte has been available in generic forms since 2008, with multiple manufacturers such as Rising, Sun Pharma Industries Ltd, and Velzen Pharma Pvt Ltd receiving FDA approval for their 2mg formulations. This generic availability has likely impacted the market dynamics, making the drug more accessible and potentially reducing costs for patients[2].

Pricing Dynamics

The pricing of brand-name prescription drugs, including those like Robinul Forte, can be subject to significant increases. A study by the Government Accountability Office (GAO) identified that brand-name drugs, including those in the central nervous system agents category, can experience extraordinary price increases of 100% or more at a single point in time. However, the presence of generic alternatives can mitigate some of these price increases[3].

Market Projections

Growing Demand

The demand for anticholinergic medications like Robinul Forte is expected to remain steady due to their use in treating various conditions, including cerebral palsy and other neurologic disorders. The rising prevalence of chronic diseases and the need for innovative therapies also contribute to the sustained demand for such medications[4].

Global Market Trends

The global pharmaceutical market, including the segment for clinical trial supplies, is expected to grow significantly. Factors such as the globalization of clinical trials, advances in biotechnology, and the introduction of new technologies in supply chain management are driving this growth. India, in particular, is emerging as a significant player in the clinical trial supplies market due to its evolving regulatory framework and highly skilled workforce[4].

Regulatory Considerations

FDA Approval and Compliance

The FDA approval process for glycopyrrolate oral solution involved a thorough evaluation of clinical pharmacology studies, including pharmacokinetic and population pharmacokinetic analyses. The approval highlighted the drug's efficacy and safety profile, particularly in pediatric patients, and addressed concerns about potential gastrointestinal manifestations that could alter absorption[1].

Safety and Adverse Events

Regulatory bodies continue to monitor postmarketing data for glycopyrrolate to identify any unexpected serious risks. A thorough search of the Adverse Event Reporting System (AERS) and examination of drug utilization data have been conducted to ensure the drug's safety profile remains favorable, especially in off-label use for conditions like drooling in children with cerebral palsy[5].

Key Takeaways

• Clinical Trials: Extensive clinical trials have established the efficacy and safety of glycopyrrolate in various patient populations.
• Market Dynamics: The availability of generic versions of Robinul Forte has impacted market pricing and accessibility.
• Regulatory Compliance: FDA approvals and ongoing safety monitoring ensure the drug's continued use is safe and effective.
• Market Projections: Growing demand driven by chronic disease prevalence and global market trends is expected to sustain the market for Robinul Forte.

FAQs

Q: What is Robinul Forte used for?

A: Robinul Forte, containing glycopyrrolate, is used to reduce salivary, tracheobronchial, and pharyngeal secretions. It is also used off-label to treat drooling in children with cerebral palsy and other neurologic conditions.

Q: Are there generic versions of Robinul Forte available?

A: Yes, generic versions of Robinul Forte have been available since 2008 from several manufacturers.

Q: What were the key findings from the clinical trials for glycopyrrolate oral solution?

A: The clinical trials showed the drug's efficacy and safety in pediatric patients with cerebral palsy or other neurologic conditions, though they noted lower bioavailability of the oral solution compared to the tablet form.

Q: What are the common adverse events associated with glycopyrrolate?

A: Common adverse events include constipation, urinary retention, and flushing, which are typical anticholinergic side effects.

Q: How is the market for Robinul Forte expected to grow in the future?

A: The market is expected to grow due to the rising prevalence of chronic diseases and the increasing demand for innovative therapies, as well as global trends in clinical trial supplies and pharmaceuticals.

Sources

1. FDA Clinical Pharmacology Studies: "Clinical Pharmacology Studies (submitted)" - FDA.
2. Generic Robinul Forte Availability: "Generic Robinul Forte Availability" - Drugs.com.
3. GAO Report on Brand-Name Prescription Drug Pricing: "Brand-Name Prescription Drug Pricing" - GAO.
4. Clinical Trial Supplies Market Forecast: "Clinical Trial Supplies Market Global Forecast Report" - GlobeNewswire.
5. FDA Medical Review: "Medical Review" - FDA.