CLINICAL TRIALS PROFILE FOR SORBITOL 3% IN PLASTIC CONTAINER

All Clinical Trials for Sorbitol 3% In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000159 ↗	Sorbinil Retinopathy Trial (SRT)	Completed	National Eye Institute (NEI)	Phase 3	1983-08-01	To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons with insulin-dependent diabetes.
NCT00121433 ↗	Leptin and Endothelial Function	Completed	Amgen	Phase 4	2004-09-01	The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.
NCT00121433 ↗	Leptin and Endothelial Function	Completed	University of Michigan	Phase 4	2004-09-01	The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	Thrasher Research Fund	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	World Bank	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.

Clinical Trial Conditions for Sorbitol 3% In Plastic Container

Condition Name

Condition Name for Sorbitol 3% In Plastic Container
Intervention	Trials
Intoxication	2
Severe Mental Illness	2
Constipation	2
Diabetic Retinopathy	1

Condition MeSH

Condition MeSH for Sorbitol 3% In Plastic Container
Intervention	Trials
Charcot-Marie-Tooth Disease	3
Tooth Diseases	3
Nerve Compression Syndromes	3
Hereditary Sensory and Motor Neuropathy	3

Clinical Trial Locations for Sorbitol 3% In Plastic Container

Trials by Country

Trials by Country for Sorbitol 3% In Plastic Container
Location	Trials
United States	27
China	5
Uzbekistan	4
Ukraine	4
Turkey	4

Trials by US State

Trials by US State for Sorbitol 3% In Plastic Container
Location	Trials
New York	3
Kansas	3
California	3
Washington	2
Ohio	2

Clinical Trial Progress for Sorbitol 3% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Sorbitol 3% In Plastic Container
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	6
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Sorbitol 3% In Plastic Container
Clinical Trial Phase	Trials
Completed	16
Recruiting	9
Unknown status	4

Clinical Trial Sponsors for Sorbitol 3% In Plastic Container

Sponsor Name

Sponsor Name for Sorbitol 3% In Plastic Container
Sponsor	Trials
Yuria-Pharm	4
Sahlgrenska University Hospital, Sweden	3
ScandiBio Therapeutics AB	3

Sponsor Type

Sponsor Type for Sorbitol 3% In Plastic Container
Sponsor	Trials
Other	48
Industry	19
NIH	1

Sorbitol: Clinical Trials, Market Analysis, and Projections

Introduction to Sorbitol

Sorbitol, also known as D-sorbitol or D-glucitol, is a sugar alcohol widely used in various industries, including food, beverages, pharmaceuticals, and personal care. This article will delve into the clinical trials related to a specific application of sorbitol, its market analysis, and future projections.

Clinical Trials Update: Sorbitol Dehydrogenase (SORD) Deficiency

One of the significant clinical trials involving sorbitol is the Phase III INSPIRE trial conducted by Applied Therapeutics. This trial focuses on treating sorbitol dehydrogenase (SORD) deficiency, a genetic condition where the body lacks the enzyme needed to break down sorbitol.

Key Findings of the INSPIRE Trial

• The trial evaluates the efficacy of Govorestat (AT-007), an oral drug, in patients with SORD deficiency. The interim results showed a statistically significant improvement in the primary endpoint at 12 months, which is the correlation of sorbitol with the Charcot Marie Tooth functional outcome measure (CMT-FOM)[1][3].
• The treatment resulted in a mean reduction of sorbitol by 52% over a 90-day period, which was highly statistically significant compared to the placebo group[3].
• Secondary endpoints also showed significant improvements, including lower limb function, mobility, fatigue, pain, sensory function, and upper limb function[1].
• The drug demonstrated a favorable safety profile with no adverse events reported[1].

Future Steps for Govorestat

Applied Therapeutics is planning to discuss a potential new drug application (NDA) submission with the FDA’s neurology division, given the positive results. Govorestat has both orphan drug and fast track designations, which could expedite its approval process[1].

Market Analysis of Sorbitol

Global Sorbitol Market Size and Growth

The global sorbitol market is experiencing substantial growth, driven by several factors:

• Market Size and CAGR: The market is expected to grow from approximately USD 1,771.2 million in 2023 to USD 3,387.8 million by 2033, at a compound annual growth rate (CAGR) of 6.7%[2].
• Segmentation: Liquid sorbitol dominates the market, holding over 76.0% of the market share in 2023, primarily used in low-calorie foods and pharmaceuticals. Crystal sorbitol is also significant, particularly in frozen food production, cosmetics, and pharmaceuticals[2].

Applications and Drivers

• Food and Beverage Industry: Sorbitol is widely used as a sugar substitute, humectant, and stabilizer. The rising demand for sugar-free and low-calorie products is a primary driver of this market growth[2][5].
• Personal Care and Cosmetics: The growing demand in the personal care and cosmetics industry, where sorbitol is used as a moisturizer and stabilizer, is another significant driver[5].
• Geographical Dominance: The Asia Pacific region dominates the sorbitol market, accounting for more than 56.2% of global revenue in 2023[2].

Sorbitol in Urologic Irrigation

Clinical Use

Sorbitol is also used in a 3% solution as a urologic irrigating fluid during transurethral surgical procedures. This solution is nonhemolytic, electrically nonconductive, and provides high visibility for endoscopic procedures. It helps in removing blood and tissue fragments and maintaining the patency of indwelling catheters[4].

Mechanism and Safety

• Mechanism of Action: The sorbitol solution acts as a lavage and is metabolized to carbon dioxide and water if absorbed, or excreted by the kidneys[4].
• Safety Profile: The solution is sterile, nonpyrogenic, and nonhemolytic, with no antimicrobial agents added. It is safe for use in urologic procedures, although it may leach small amounts of chemical components from the plastic container[4].

Market Projections

Growth Drivers

• Health and Wellness Trends: Increasing consumer focus on health and wellness, along with a preference for natural and plant-based ingredients, is boosting the adoption of sorbitol as an alternative to traditional sugars[2][5].
• Expanding Applications: Sorbitol’s versatility extends to various industries, including the production of bio-based ethanol and propylene glycol, which will continue to drive market growth[2].

Challenges and Opportunities

• Raw Material Volatility: The market faces challenges such as volatility in raw material prices, particularly for crops like corn used in sorbitol production. However, this also presents opportunities for innovation in sourcing and production methods[2].
• Regulatory Environment: The regulatory environment, especially with regards to food and pharmaceutical applications, will play a crucial role in shaping the market’s future growth[2].

Key Takeaways

• Clinical Trials: The INSPIRE trial for SORD deficiency has shown promising results with Govorestat, paving the way for potential FDA approval.
• Market Growth: The global sorbitol market is expected to grow significantly, driven by demand in the food, beverage, and personal care industries.
• Applications: Sorbitol is versatile, used in various forms and applications, including urologic irrigation.
• Geographical Dominance: The Asia Pacific region is the largest market for sorbitol.

Frequently Asked Questions (FAQs)

What is the current status of the INSPIRE trial for SORD deficiency?

The INSPIRE trial has shown positive interim results, with statistically significant improvements in primary and secondary endpoints. The trial is ongoing, with plans for a potential NDA submission to the FDA[1][3].

What are the primary applications of sorbitol in the market?

Sorbitol is primarily used as a sugar substitute, humectant, and stabilizer in the food and beverage industry. It is also used in pharmaceuticals, personal care products, and as a urologic irrigating fluid[2][5].

What are the growth drivers for the sorbitol market?

The growth drivers include increasing demand for sugar-free and low-calorie products, rising consumer focus on health and wellness, and expanding applications in various industries[2][5].

What are the challenges faced by the sorbitol market?

The market faces challenges such as volatility in raw material prices and potential regulatory hurdles, but these also present opportunities for innovation and growth[2].

Which region dominates the global sorbitol market?

The Asia Pacific region dominates the global sorbitol market, accounting for more than 56.2% of global revenue in 2023[2].

Cited Sources

1. Applied aims for approval post-Phase III win with SORD deficiency drug - Clinical Trials Arena
2. Sorbitol Market to Reach USD 3387.8 Million by 2033, CAGR 6.7% - News Market
3. Applied Therapeutics Announces Positive Sorbitol Reduction Data From the Ongoing Phase 3 INSPIRE Trial in Sorbitol Dehydrogenase (SORD) Deficiency - Applied Therapeutics
4. Sorbitol (irrigation) - Wikidoc
5. Sorbitol Market Size Report, 2022-2027 - IndustryARC

Last updated: 2025-01-02