➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Harvard Business School
Johnson and Johnson
Medtronic
Merck

Last Updated: September 26, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR IRON SUCROSE

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

505(b)(2) Clinical Trials for Iron Sucrose

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00262145 ↗ Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption Completed NatureGen Phase 1 2005-10-01 Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by the intestinal mucosa). There has been some study of the ability of these products to reduce the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol levels in chronic studies. The purpose of the present study is to objectively determine if one cup of “tea” made from a combination of three types of tea leaves (mulberry, black and green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea. Research Design - The study will consist of a double blind, placebo controlled crossover study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon. On one of the test days the subjects (randomly) will concurrently consume the active preparation, a tea containing extracts of the three types of tea leave described above plus the meal, and on the other test day they will consume the meal with a liquid placebo preparation (warm water, sugar and food coloring). Subjects will provide a breath sample before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate malabsorption will be determined by the hydrogen concentration in the breath samples and fat malabsorption by the concentration of 13-CO2 in the breath samples. Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption and a low 13-CO2 indicates lipid malabsorption. Objective evidence that the tea leaf extract actually induces carbohydrate and/or fat malabsorption could provide the basis for further studies.
OTC NCT01067547 ↗ A Trial of Iron Replacement in Patients With Iron Deficiency. Completed Richard Fedorak Phase 4 2010-03-01 Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or intravenous route in Inflammatory Bowel Disease patients. Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD) and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor quality of life, poor concentration span and low energy level. Blood transfusion may improve symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born infection transmission. Moreover, packed cells are scarce resource therefore its use needs to be carefully prioritized. Oral iron supplement has been widely used and it can be purchased over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly tolerated with side effects include altered bowel habit, nausea and darken stools, making it difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has been supported by its post marketing surveillance. Limitations with intravenous iron replacement include the need for medical supervision in the setting of limited healthcare resources; the need for patients to take multiple days off work and the cost of Venofer®. Currently it is uncertain which method of iron replacement is better. The purpose of this study is to compare the efficacy and the cost of oral and intravenous iron replacement in the setting of iron deficiency anaemia.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Iron Sucrose

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00111956 ↗ Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A 2004-04-01 Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00125996 ↗ Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure Unknown status 4th Military Hospital, Poland Phase 1/Phase 2 2004-07-01 This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.
NCT00125996 ↗ Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure Unknown status Wexham Park Hospital Phase 1/Phase 2 2004-07-01 This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Iron Sucrose

Condition Name

Condition Name for Iron Sucrose
Intervention Trials
Anemia 20
Pain 14
Iron Deficiency Anemia 10
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Iron Sucrose
Intervention Trials
Anemia, Iron-Deficiency 36
Anemia 30
Kidney Diseases 16
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Iron Sucrose

Trials by Country

Trials by Country for Iron Sucrose
Location Trials
United States 68
Canada 16
United Kingdom 7
India 6
Austria 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Iron Sucrose
Location Trials
Pennsylvania 9
Florida 7
Massachusetts 6
Maryland 5
Colorado 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Iron Sucrose

Clinical Trial Phase

Clinical Trial Phase for Iron Sucrose
Clinical Trial Phase Trials
Phase 4 32
Phase 3 33
Phase 2/Phase 3 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Iron Sucrose
Clinical Trial Phase Trials
Completed 65
Recruiting 26
Not yet recruiting 19
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Iron Sucrose

Sponsor Name

Sponsor Name for Iron Sucrose
Sponsor Trials
Luitpold Pharmaceuticals 12
AMAG Pharmaceuticals, Inc. 4
Vifor Inc. 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Iron Sucrose
Sponsor Trials
Other 122
Industry 55
NIH 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Colorcon
AstraZeneca
Boehringer Ingelheim
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.