Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops is an antihistaminic, antitussive, and decongestant drop for oral administration.
Each dropperful (1 mL) contains:
Chlorpheniramine Maleate, USP.............. 0.8 mg
Dextromethorphan HBr, USP..................... 3 mg
Pseudoephedrine HCl, USP........................ 9 mg
Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops is indicated for symptomatic relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Clinical Trials Related to Chlorphen Mal Dex HBr Pseudoeph (Chlorpheniramine / Pseudoephedrine / Dextromethorphan)
Study of AHIST in Seasonal Allergic Rhinitis Patients [Not yet recruiting]
A) To gather pharmacodynamic measurements and assess blood levels of the active ingredients
in AHIST over the dosage interval period of 12 hours.
Hypothesis: Hysteresis curves plotting each active ingredient's blood levels over a 12-hour
dosage interval will substantiate S5 Symptom Diary scores (IE: evidentiary therapeutic
B) To report subjective scores by subjects rating the efficacy of a single dose AHIST in
relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over a
12-hour dosage interval.
Hypothesis: Greater than 66% of subjects will document clinically significant relief over a
12-hour period from one dose of AHIST;
C) Report any side effects or adverse drug reactions and rate the severity of any incidence.
Hypothesis: Not more than one patient will have an adverse event significant enough to
warrant withdrawal; side effects will be mild with the most frequently reported side effect
occurring in less than 10% of patients—drowsiness.
Evaluation of Efficacy and Safety of Oral Solution Resfenol in Reducing Symptoms of Common Cold And Flu [Not yet recruiting]
This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol,
chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the
common cold. There will be a randomized, double-blind, placebo-controlled trial. Will be
included 216 subjects, male or female, aged greater than 12 and less than or equal to 60
years, irrespective of color and / or race with symptoms of recent onset, for more than 6
hours and less than 48 hours length, characterizing Common Cold and / or Influenza.
After clinical evaluation and laboratory research subjects will be randomized to receive
active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. The follow-up visits
will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first
The outcomes to assess the effectiveness so far consist of the scores of symptoms and to
assess the safety of the drug will be accompanied by the emergence of adverse events.
Efficacy and Safety Assessment of an Anti-Cold Preparation in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome [Recruiting]
The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza. [Not yet recruiting]
This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group,
single-dose study will assess the efficacy and tolerability of the active tablets versus
placebo in participants suffering from cold and influenza. Eligible participants will be
randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a
four-hour (hr) treatment phase. Each participant will be administered only once during each
study period. Participants will use a questionnaire to record the symptom severity scores as
described, as well as time.
Mechanisms of N-acetylcysteine Mediated Vascular Adverse Effects [Recruiting]
Paracetamol overdose is the leading cause of acute liver failure in the Western World.
N-acetylcysteine (NAC) has been the antidote of choice for over 30 years but its use is
associated with adverse effects in 40% of cases. Patients characteristically experience
nausea, vomiting and an anaphylactoid ('pseudo-allergic') syndrome. This reaction is
clinically similar to true anaphylaxis (allergic reaction) including flushing, rash,
constriction of airways, and a fall in blood pressure, but occurs via a different mechanism.
Although treatable, these reactions lead to patient distress, commonly cause confusion among
treating physicians, and lead to significant delays in antidote administration. The
aetiology of these adverse reactions to NAC remains unclear. We hypothesise: i) these
reactions result from a dose-dependent release of the chemical histamine, causing dilatation
of blood vessels (vasodilatation) and the anaphylactoid syndrome; ii) paracetamol conversely
exerts a protective effect on the reaction, with a less severe reaction observed in the
presence of higher paracetamol concentrations. We will investigate the mechanisms underlying
adverse reactions to NAC in the human forearm model, examining the role of histamine and
other markers involved in the inflammatory process. The wider significance is an improved
understanding of this poorly delineated phenomenon, with implications for other medications
associated with similar reactions, such as non-steroidal anti-inflammatory drugs and opioids
such as morphine.
Page last updated: 2010-01-21