GLYCINE SUMMARY
1.5% Glycine Irrigation, USP is a sterile, nonpyrogenic, nonhemolytic, nonelectrolytic or very weakly ionized solution in single dose UROMATIC containers for use as a urologic irrigating solution. Each liter contains 15 g Glycine, USP (NH2CH2COOH) in water for injection. pH 6.0 (4.5 to 6.5). Osmolarity 200 mOsmol/L (calc.). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. No antimicrobial agent has been added.
The UROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
1.5% Glycine Irrigation, USP is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. It may be used for lavage of an indwelling catheter to maintain patency.
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NEWS HIGHLIGHTS
Published Studies Related to Glycine (Glycine Urethral)
Randomized proof of concept trial of GLYX-13, an N-methyl-D-aspartate receptor
glycine site partial agonist, in major depressive disorder nonresponsive to a
previous antidepressant agent. [2015] CONCLUSION: In this early POC study, GLYX-13 reduced depressive symptoms within 2
The beneficial effect of soybean (Glycine max (L.) Merr.) leaf extracts in adults
with prediabetes: a randomized placebo controlled trial. [2014] The present study investigated the effects of soybean leaf extracts (SLEs) on
blood glucose, insulin resistance, body fat and dyslipidemia in prediabetes
subjects, and compared them with the effects of banaba extracts (BE) which is
known to ameliorate diabetes in several animals and clinical studies...
Inhibition of glycine transporter-I as a novel mechanism for the treatment of
depression. [2013] a treatment for depression... CONCLUSIONS: Our preliminary findings suggest that enhancing NMDA function can
Evaluation of the glycine transporter inhibitor Org 25935 as augmentation to
cognitive-behavioral therapy for panic disorder: a multicenter, randomized,
double-blind, placebo-controlled trial. [2012] CONCLUSIONS: Org 25935 demonstrated no benefit over placebo in augmenting CBT for
A double-blind, placebo-controlled trial of the NMDA glycine site antagonist, GW468816, for prevention of relapse to smoking in females. [2011.10] Relapse to smoking is common after initial abstinence with pharmacotherapy and behavioral support and represents a major clinical challenge... There was no effect of treatment on abstinence rates at the end of treatment (chi(2) [1, n = 96] = 0.168, P = 0.838), on the rates of relapse (chi(2) [1, n = 98] = 0.031, P = 1.000) or lapse (chi(2) [1, n = 62] = 0.802, P = 0.423), or on time to relapse (chi(2) [1, n = 98) = 0.001, P = 0.972).
Clinical Trials Related to Glycine (Glycine Urethral)
Acute Glycine Pharmacodynamic Study [Completed]
The purpose of this study is to use proton magnetic resonance spectroscopy (MRS) at 4 Tesla
to measure brain glycine levels noninvasively at baseline and for 2 hours after a single
oral dose of a concentrated glycine-containing beverage, and to compare MRS glycine
measurements to glycine blood levels in samples obtained after each MRS spectrum.
The investigators hypothesize that they will observe a high correlation between the
magnitude increases in brain and plasma glycine levels over this time frame.
The investigators also hypothesize that we will observe large intersubject variability in
glycine uptake rates into brain and blood.
The investigators also hypothesize that subjects with a glycine decarboxylase (GLDC)
mutation (triplication) will have lower baseline plasma and brain glycine levels and will
experience smaller brain and plasma glycine increases after glycine consumption than
controls or family members without the GLDC mutation.
Effect of Glycine in Cystic Fibrosis [Terminated]
The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0. 5
g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic
fibrosis, as compared with placebo. During all of the study children will receive their
usual treatment for cystic fibrosis.
Glycine and Oral D-Cycloserine in Alcoholic Patients and Healthy Subjects [Completed]
Question #1: Will glycine ameliorate cognitive deficits? Hypothesis #1: Based on positive
findings conducted with glycine and milacemide, a glycine prodrug, in schizophrenia and
dementia, we expect that glycine will ameliorate cognitive deficits.
Question #2: Will alcoholic patients show enhanced endocrinal effects to glycine? Hypothesis
#2: Based on the dose-related effects of glycine in healthy subjects, we expect that glycine
will increase the endocrinal response to glycine in alcoholic patients with, supposedly,
dysregulated NMDA receptor function.
Question #3: Will D-cycloserine have ethanol-like effects? Hypothesis #3: If inhibition of
NMDA receptor function is fundamental to the subjective effects of ethanol, then the NMDA
antagonist properties of D-cycloserine should be recognized as ethanol-like (relative to
placebo) in recently detoxified alcoholics and healthy subjects.
Question #4: Will D-cycloserine reverse cognitive benefits of glycine? Hypothesis 4: Based
on the dose related NMDA antagonist activity of D-cycloserine, we expect that D-cycloserine
will compete with the agonist activity of glycine and therefore it will reverse the
cognitive benefits of glycine.
Question #5: Will D-cycloserine inhibit endocrinal effects of glycine? Hypothesis #5: If the
agonist activity of glycine is necessary to determine endocrine response, then the
dose-related NMDA antagonist properties of D-cycloserine should block these effects.
Glycine and D-Cycloserine in Schizophrenia [Withdrawn]
The purpose of this study is to compare the effects of D-cycloserine and glycine for
treating negative symptoms (such as loss of interest, loss of energy, loss of warmth, and
loss of humor) which occur between phases of positive symptoms (marked by hallucinations,
delusions, and thought confusions) in schizophrenics.
Clozapine is currently the most effective treatment for negative symptoms of schizophrenia.
Two other drugs, D-cycloserine and glycine, are being investigated as new treatments.
D-cycloserine improves negative symptoms when added to some drugs, but may worsen these
symptoms when given with clozapine. Glycine also improves negative symptoms and may still
be able to improve these symptoms when given with clozapine. This study gives either
D-cycloserine or glycine (or an inactive placebo) with clozapine to determine which is the
best combination.
Patients will be assigned to 1 of 3 groups. Group 1 will receive D-cycloserine plus
clozapine. Group 2 will receive glycine plus clozapine. Group 3 will receive an inactive
placebo plus clozapine. Patients will receive these medications for 8 weeks. Negative
symptoms of schizophrenia will be monitored through the Scale for the Assessment of Negative
Symptoms, Positive symptoms will be monitored through the Positive and Negative Syndrome
Scale, and additionally subjects will complete the Brief Psychiatric Rating Scale and the
Global Assessment Scale.
An individual may be eligible for this study if he/she is 18 to 65 years old and has been
diagnosed with schizophrenia.
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Page last updated: 2015-08-10
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