Last Updated: May 31, 2026

CLINICAL TRIALS PROFILE FOR DYCLONINE HYDROCHLORIDE


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All Clinical Trials for dyclonine hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01566448 ↗ Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash Completed Aaron Cumpston, PharmD Phase 2 2012-02-01 Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because the pain from mucositis can be so bad it can cause the inability to eat or drink, inability to talk, gagging and drooling. Many times mucositis can affect cancer treatment because patients may have to be given a lower dose of a drug or stop treatment completely. There are not many treatments today that can help relieve the severe pain caused from mucositis. This research study will help researchers determine if using an oral mouthwash called Ketamine will help lessen mucositis pain. Ketamine is approved by the Food and Drug Administration (FDA) for use with general anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a standard treatment option for mucositis pain. During this study patients will be assessed to determine the level of pain caused by their mucositis. This will occur before the first dose, one hour after the first dose, and then daily until they are no longer on the study. Patients will use the mouthwash by swishing and spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will use the mouthwash on this study until their mucositis gets better or until the mucositis gets worse (or if the pain does not get better after three days of treatment).
NCT01566448 ↗ Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash Completed Aaron Cumpston, PharmD, BCOP Phase 2 2012-02-01 Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because the pain from mucositis can be so bad it can cause the inability to eat or drink, inability to talk, gagging and drooling. Many times mucositis can affect cancer treatment because patients may have to be given a lower dose of a drug or stop treatment completely. There are not many treatments today that can help relieve the severe pain caused from mucositis. This research study will help researchers determine if using an oral mouthwash called Ketamine will help lessen mucositis pain. Ketamine is approved by the Food and Drug Administration (FDA) for use with general anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a standard treatment option for mucositis pain. During this study patients will be assessed to determine the level of pain caused by their mucositis. This will occur before the first dose, one hour after the first dose, and then daily until they are no longer on the study. Patients will use the mouthwash by swishing and spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will use the mouthwash on this study until their mucositis gets better or until the mucositis gets worse (or if the pain does not get better after three days of treatment).
NCT03352700 ↗ Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy Unknown status Changhai Hospital Phase 4 2017-12-01 In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.
NCT06729307 ↗ Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy NOT_YET_RECRUITING Peking Union Medical College Hospital PHASE4 2025-01-01 The goal of this clinical trial is to learn if administering ondansetron prior to esophagogastroduodenoscopy (EGD) can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are: Does taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? Does taking ondansetron prior to EGD reduce the intensity of patient gagging and nausea, and the incidence of vomiting ? Researchers will compare premedication of oral ondasetron and topical pharyngeal anesthesia (dyclonine hydrochloride mucilage) with topical pharyngeal anesthesia only to see if ondansetron can exert the above-mentioned effects. Participants will be treated with one of the following regimens according to the randomization result: * Oral ondansetron of 8 mg 2 hours prior to endoscopic process and dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process; * dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process. After the endoscopic process is finished, patients will be asked to fill in a questionnaire that contains the following items, all measured by NRS 0-10: * Overall discomfort; * Intensity of gagging; * Willingness to undergo unsedated EGD again if indicated.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for dyclonine hydrochloride

Condition Name

Condition Name for dyclonine hydrochloride
Intervention Trials
Esophagogastroduodensocopy (EGD) Procedure 2
Adenoma Detection Rate 1
Bowel Preparation Scale 1
Esophagogastroduodenoscopy 1
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Condition MeSH

Condition MeSH for dyclonine hydrochloride
Intervention Trials
Gastrointestinal Hemorrhage 1
Adenoma 1
Mucositis 1
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Clinical Trial Locations for dyclonine hydrochloride

Trials by Country

Trials by Country for dyclonine hydrochloride
Location Trials
China 2
United States 1
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Trials by US State

Trials by US State for dyclonine hydrochloride
Location Trials
West Virginia 1
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Clinical Trial Progress for dyclonine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for dyclonine hydrochloride
Clinical Trial Phase Trials
PHASE4 3
Phase 4 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for dyclonine hydrochloride
Clinical Trial Phase Trials
NOT_YET_RECRUITING 2
ACTIVE_NOT_RECRUITING 1
Completed 1
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Clinical Trial Sponsors for dyclonine hydrochloride

Sponsor Name

Sponsor Name for dyclonine hydrochloride
Sponsor Trials
Peking Union Medical College Hospital 3
Aaron Cumpston, PharmD 1
Aaron Cumpston, PharmD, BCOP 1
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Sponsor Type

Sponsor Type for dyclonine hydrochloride
Sponsor Trials
Other 6
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Last updated: May 17, 2026

clonine Hydrochloride Clinical Trials Update and Market Projection (2026) Dyclonine hydrochloride is a topical/local anesthetic used for symptomatic relief (commonly in oral/throat and related mucosal conditions). No complete, up-to-date global clinical-trials dataset and no reliable, single-source commercial revenue baseline are provided in the available input, so a fact-complete “clinical trials update” and “market projection” cannot be produced in a way that meets high-stakes patent, regulatory, and investment decision standards.

What clinical trials use dyclonine hydrochloride, and what is the latest status?

Featured snippet: No latest trial status or results can be compiled from the provided information; a complete clinical-trials update requires trial identifiers and verified stage data.

Which indications are dyclonine hydrochloride tested for?

  • Oral mucosal pain and sore throat symptom relief
  • Local anesthesia for minor procedures (where relevant to labeling and formulation)
  • Other mucosal pain syndromes reported in the literature

Which trial designs are typically used?

  • Randomized, controlled, symptomatic-outcome endpoints (pain scores, swallowing discomfort, irritation scales)
  • Safety endpoints focused on local tolerability and adverse event monitoring

What is the dyclonine hydrochloride market size, and how fast is it growing?

Featured snippet: A market-size and growth-rate projection cannot be stated from the provided information.

Where does demand concentrate?

  • OTC and prescription channels for local symptomatic relief products
  • Geography typically driven by cold-chain-independent OTC distribution and formulary access for mucosal pain brands

What drives utilization?

  • Product availability in throat and oral pain categories
  • Competitive positioning vs other local anesthetics and anti-inflammatories
  • Regulatory and labeling constraints for mucosal use

What can cap growth or shift demand?

  • Safety or tolerability scrutiny for local anesthetic exposure
  • Switchability to alternatives with stronger differentiation (rapid onset, longer duration, broader indication language)

When does dyclonine hydrochloride lose exclusivity or face generic pressure?

Featured snippet: Exclusivity and generic entry timing cannot be calculated without known reference product(s), listed patents, and Orange Book or equivalent filing data.

What usually drives generic timelines for small-molecule topical anesthetics?

  • Composition of matter and formulation patent coverage (if any) for specific dosage forms
  • Method-of-use claims tied to indication language
  • Regulatory exclusivities (if supported by the drug’s NDA/BLA history)

What patents cover dyclonine hydrochloride formulations and methods of use?

Featured snippet: A defensible patent landscape cannot be produced without patent numbers, assignees, or a specified jurisdiction and reference listed products.

Typical patent buckets (information needed to enumerate)

  • API composition or salts (including dyclonine hydrochloride forms)
  • Topical formulation compositions (gels, sprays, lozenges, mouthwashes)
  • Stabilizers, permeation enhancers, and taste-masking systems
  • Manufacturing processes for uniformity and viscosity control
  • Method-of-use for specific mucosal pain indications

What FDA status does dyclonine hydrochloride have (Orange Book, approvals, labeling)?

Featured snippet: FDA regulatory status cannot be verified or summarized from the provided information.

What would be needed to map FDA status to IP risk

  • Specific NDA/ANDA references for the marketed dosage forms
  • Orange Book listing entries and expiration dates
  • Label claim alignment with any method-of-use patents

How does dyclonine hydrochloride compare with competing local anesthetics for mucosal pain?

Featured snippet: A quantified comparison cannot be produced without the competing products’ market positioning, clinical evidence summaries, and dosing-formulation attributes for the same indication set.

Competitive set (category-level)

  • Other local anesthetics used in throat/oral pain products
  • Combinations that pair anesthetic action with anti-inflammatory or antiseptic components

What to compare in head-to-head market terms

  • Onset and duration (symptom score endpoints)
  • Form factor adoption (spray vs lozenge vs viscous gel)
  • Safety profile and labeling restrictions
  • Back-of-pack dosing convenience and adherence

What is the most likely market-entry scenario for generics or reformulations?

Featured snippet: Entry scenarios cannot be projected without the reference product(s), patent expiry dates, and ANDA filing patterns.

Scenario mechanics

  • If formulation patents remain: generics face reformulation or design-around requirements
  • If method-of-use claims remain: labeling carve-outs and Paragraph IV strategy affect launch timing
  • If exclusivity expires: standard bioequivalence pathway reduces launch friction

Key Takeaways

  • A clinical-trials update and market projection for dyclonine hydrochloride cannot be completed to a decision-grade standard from the provided information.
  • A defensible answer requires verified trial status records and verified FDA/Orange Book and patent listing data for specific dyclonine hydrochloride products and dosage forms.

FAQs

  1. Which dyclonine hydrochloride formulations are most common globally (spray, lozenge, gel), and how do they differ in clinical endpoints?
  2. Are there any active dyclonine hydrochloride clinical trials registered on ClinicalTrials.gov, and what endpoints do they use?
  3. What Orange Book entries exist for dyclonine hydrochloride products in the U.S., and what are their expiration dates?
  4. Do dyclonine hydrochloride products face Paragraph IV litigation, and what settlement patterns apply?
  5. How do dyclonine hydrochloride products perform vs other local anesthetics on pain-relief and tolerability outcomes?

References

(No sources were provided in the input to cite.)

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