Glycine (Glycine Urethral) - Summary

GLYCINE SUMMARY

1.5% Glycine Irrigation, USP is a sterile, nonpyrogenic, hypotonic, aqueous solution of glycine intended only for urologic irrigation during transurethral surgical procedures.Each 100 mL contains 1.5 g of glycine in water for injection. The solution is nonelectrolytic, hypotonic and has an osmolarity of 200 mOsmol/liter (calc.); pH 6.0 (4.5 to 6.5).The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose irrigation. When smaller volumes are required, the unused portion should be discarded.1.5% Glycine Irrigation is a urologic nonelectrolyte irrigant.Glycine, USP is chemically designated aminoacetic acid (C₂H₅NO₂), a white crystalline powder freely soluble in water. It has the following structural formula:NH₂CH₂COOHWater for Injection, USP is chemically designated H₂0.The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration.The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

1.5% Glycine Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.

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NEWS HIGHLIGHTS

Published Studies Related to Glycine (Glycine Urethral)

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).

The impact of anesthesia on glycine absorption in operative hysteroscopy: a randomized controlled trial. [2011.10]
BACKGROUND: Operative hysteroscopy requires the use of a distension medium and its absorption can lead to serious consequences from intravascular volume overload and water intoxication. We compared the impact of 2 types of anesthesia (general anesthesia and local anesthesia with sedation) on the absorption of glycine solution in operative hysteroscopy... CONCLUSION: Compared with general anesthesia, local anesthesia with sedation is associated with less glycine absorption and should be considered the preferred method of anesthesia for operative hysteroscopy.

Randomized Controlled Trial Assessing Efficacy and Safety of Glycine Powder Air Polishing in Moderate to Deep Periodontal Pockets. [2011.08.23]
Background: Supragingivally applied glycine powder air polishing (Supra-GPAP) has been shown to remove biofilms in shallow periodontal pockets. This study assessed efficacy and safety of subgingivally applied glycine powder air polishing (Sub-GPAP) in moderate to deep periodontal pockets... Furthermore, Full-mouth GPAP may result in a beneficial shift of the oral microbiota and appears to be well tolerated.

Effects of glycine supplementation at varying levels of methionine and cystine on the growth performance of broilers fed reduced crude protein diets. [2011.05]
Two experiments were conducted to investigate Gly addition to reduced crude protein corn-soybean meal (C-SBM) diets with varying levels of TSAA achieved by varying Met and Cys. The experiments were conducted with female Ross 708 broilers in brooder batteries from 0 to 18 d posthatching...

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Clinical Trials Related to Glycine (Glycine Urethral)

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 to Treat Psychotic Disorders in Children [Completed]
This study will test the safety and effectiveness of the amino acid glycine in treating psychotic disorders in children. The drug will be given as an adjunct (in addition) to the patient's current antipsychotic medication.

Children age nine to 18 with schizophrenia or schizoaffective disorder whose symptoms began before age 13 may be eligible for this 10-week study. Patients will be hospitalized during the course of the trial. Weekend visits home may be permitted.

Children enrolled in the study will be evaluated during a two-week pre-treatment period with written tests for IQ and academic functioning and with a magnetic resonance imaging (MRI) scan of the brain. For the MRI, the child lies on a table that slides into a large donut-shaped machine with a strong magnetic field. This procedure produces images of the brain that may help identify brain abnormalities in schizophrenia that develop in childhood.

During the eight-week treatment phase, patients will receive glycine powder dissolved in water once a day, in addition to their other antipsychotic medications. They will undergo the following additional procedures during the course of treatment:

1. Comprehensive psychiatric examination

2. Blood pressure and pulse monitoring once a week

3. Blood tests every other week - About one ounce of blood is drawn per week to measure

glycine levels

4. Eye movement study at week eight - Using a technique called infrared oculography,

special detectors measure infrared light reflected off the child's eyes while he or she watches a moving square on a video monitor.

5. Lumbar puncture (spinal tap) once during the study - About one-half ounce of

cerebrospinal fluid (the fluid surrounding the brain and spinal cord) is withdrawn through a needle placed in the lower part of the spine for analysis of brain chemicals.

Patients who respond well may continue to receive glycine treatment through their referring physician after the study is completed.

NIMH will follow patients by phone every six months and with visits at two-year intervals.

A Study of the Effects of Sarcosine on Symptoms and Brain Glycine Levels in People With Schizophrenia [Recruiting]
The purpose of this study is to evaluate the effect of a dietary supplement on the concentration of a small protein called glycine that is found in the brain in people with schizophrenia. The dietary supplement is called sarcosine. We want to see how taking sarcosine for 6 weeks affects levels of glycine in the brain. Sarcosine and glycine are both part of the proteins that occur naturally in our bodies. The study involves 6 weeks of taking sarcosine or placebo added to your regular drugs. A placebo looks exactly like sarcosine, but does not contain active drug. In this study, the placebo will not contain any dietary supplement.

Sarcosine is a dietary supplement which is not FDA approved for treatment of any specific medical or nutritional use.

It is thought that increasing concentrations of the protein, glycine, in brain will improve some symptoms of schizophrenia. This study tests whether taking sarcosine will increase brain concentration of glycine and whether this is correlated with any change in symptoms.

We are asking you to take part in this study because you have been diagnosed with schizophrenia or schizoaffective disorder and because you smoke cigarettes.

If you decide to take part in this study, we will use a magnetic resonance brain scan (MRS) to measure the glycine levels in your brain. We hope that this study will help us to better understand the brains of people with schizophrenia.

The brain scans will be done at McLean Hospital in Belmont, MA. We will provide transportation to and from McLean.

Sarcosine is a naturally occurring substance. It is found in muscles and other body tissues. It is also found in food such as egg yolk, ham, turkey, and vegetables. Sarcosine has been studied in 2 other studies that involved a total of 38 people with schizophrenia who took sarcosine. It was shown to improve some symptoms of schizophrenia. No study has looked at whether sarcosine changes brain glycine levels. We expect that about 70 people will enroll in this study at the Massachusetts General Hospital (MGH).

This is an early study, called a 'pilot' study that is being conducted to learn how the compound sarcosine affects brain glycine levels.

Effect of Glycine in Cystic Fibrosis [Recruiting]
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.

Adjunctive Glycine for Obsessive Compulsive Disorder [Completed]
The purpose of this study is to determine whether individuals with obsessive compulsive disorder who will take a preparation of the amino acid glycine in addition to their current treatment, may experience improvement in their symptoms.

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