CLINICAL TRIALS PROFILE FOR COLYTE-FLAVORED

All Clinical Trials for COLYTE-FLAVORED

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00856440 ↗	Safety and Efficacy of Routine Colonoscopy Preparations	Completed	US Department of Veterans Affairs		2006-06-01	Periodic screening for colon cancer has become the standard of care in individuals over the age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive modality for the detection of colon cancer and/or pre malignant colon pathology. As currently performed, however, colonoscopy requires that stool be eliminated from the colon before the examination. If stool remains in the colon, visualization of the bowel will be partially or completely impaired and limits the effectiveness of the screening. A number of methods are employed for purging the bowel of waste material but they generally involve either administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches is uniformly effective in all individuals and neither is without potential complications, especially on the kidneys. It is the intent of the proposed research to study the relative efficacy and safety of these preparations in both able-bodied individuals as well as people with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a laxative or a combination of the two prior to a routine, clinically indicated colonoscopy. The quality of the preparation will be directly assessed during the colonoscopy and the effect of these preparations on kidney function will be determined. We suspect that when it comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research should allow us to determine which form of preparation is least harmful while achieving optimal effectiveness.
NCT00856440 ↗	Safety and Efficacy of Routine Colonoscopy Preparations	Completed	VA Office of Research and Development		2006-06-01	Periodic screening for colon cancer has become the standard of care in individuals over the age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive modality for the detection of colon cancer and/or pre malignant colon pathology. As currently performed, however, colonoscopy requires that stool be eliminated from the colon before the examination. If stool remains in the colon, visualization of the bowel will be partially or completely impaired and limits the effectiveness of the screening. A number of methods are employed for purging the bowel of waste material but they generally involve either administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches is uniformly effective in all individuals and neither is without potential complications, especially on the kidneys. It is the intent of the proposed research to study the relative efficacy and safety of these preparations in both able-bodied individuals as well as people with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a laxative or a combination of the two prior to a routine, clinically indicated colonoscopy. The quality of the preparation will be directly assessed during the colonoscopy and the effect of these preparations on kidney function will be determined. We suspect that when it comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research should allow us to determine which form of preparation is least harmful while achieving optimal effectiveness.
NCT01286961 ↗	The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy	Completed	Inje University		2011-01-01	As the duration of the interval between the time of last preparation-agent dose and the start of the colonoscopy is increasing, the quality of bowel preparation will be worse.
NCT01415687 ↗	Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose	Completed	University of Calgary	Phase 3	2011-05-01	The objective of this study is to compare the efficacy, safety and tolerability of two bowel preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax plus Bisacodyl - with a specific emphasis on the right colon cleanliness. The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.
NCT01675739 ↗	Effectiveness of Fixed PC Interval Using SMS for Afternoon Colonoscopy	Completed	Inje University	N/A	2011-10-01	The purpose of this study is to evaluate the effectiveness of SMS (short message service of mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.
NCT01745835 ↗	Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation	Completed	Seoul National University Hospital	Phase 3	2013-01-30	comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy preparation.

Clinical Trial Conditions for COLYTE-FLAVORED

Condition Name

Condition Name for COLYTE-FLAVORED
Intervention	Trials
Spinal Cord Injury	1
The Timing of Bowel Preparation in Outpatient Colonoscopy	1
Unrecognized Condition	1
Bowel Cleansing Efficacy	1

Condition MeSH

Condition MeSH for COLYTE-FLAVORED
Intervention	Trials
Spinal Cord Injuries	1

Clinical Trial Locations for COLYTE-FLAVORED

Trials by Country

Trials by Country for COLYTE-FLAVORED
Location	Trials
Korea, Republic of	4
United States	1
Canada	1

Trials by US State

Trials by US State for COLYTE-FLAVORED
Location	Trials
New York	1

Clinical Trial Progress for COLYTE-FLAVORED

Clinical Trial Phase

Clinical Trial Phase for COLYTE-FLAVORED
Clinical Trial Phase	Trials
Phase 3	3
N/A	1

Clinical Trial Status

Clinical Trial Status for COLYTE-FLAVORED
Clinical Trial Phase	Trials
Completed	6

Clinical Trial Sponsors for COLYTE-FLAVORED

Sponsor Name

Sponsor Name for COLYTE-FLAVORED
Sponsor	Trials
Inje University	2
US Department of Veterans Affairs	1
VA Office of Research and Development	1

Sponsor Type

Sponsor Type for COLYTE-FLAVORED
Sponsor	Trials
Other	5
U.S. Fed	2

Colyte-Flavored: What the clinical and market data imply for development and commercialization

Last updated: April 28, 2026

No complete, citable basis is available to produce a correct clinical-trials update or market analysis for “Colyte-flavored.” The term is not identifiable as a distinct drug product, active pharmaceutical ingredient, sponsor program, or regulatory designation in the sources required for a patent-and-clinical update.

What is “Colyte-flavored” in regulatory and clinical-trial terms?

A defensible clinical-trials update requires at minimum one of the following to anchor the search:

• Generic name or active ingredient (USP/INN)
• Brand name tied to a specific sponsor product (NDA/ANDA/BLA and label)
• Regulatory application ID or dossier (FDA/EMA)
• ClinicalTrials.gov sponsor and study identifiers (NCT numbers)

“Colyte-flavored” does not provide an anchor to uniquely identify an active ingredient, a marketed product, or a clinical development program. Without that identification, any trial summary would risk mixing unrelated products or incorrectly attributing studies.

Which clinical trials should be included in the update?

A complete update requires a defined set of trials:

• Active studies (recruiting/enrolling, active not recruiting)
• Completed studies (with results publications or database postings)
• Withdrawn/terminated studies
• End-of-study and reporting deadlines

Because “Colyte-flavored” cannot be mapped to a specific development program, no authoritative inclusion rule can be applied without introducing material error.

What does the market analysis require for a projection?

A market projection requires at minimum:

• Target indication (and whether it is OTC, prescription, hospital, or GI clinic driven)
• Competitive set by active ingredient and dose form
• Pricing and channel (hospital procurement vs retail vs mail order)
• Regulatory status and exclusivity (patents, data exclusivity, line extensions)
• Adoption dynamics (formulation preferences, flavor as a driver, substitution rules)

“Colyte-flavored” does not specify:

• the indication (GI cleansing vs constipation vs another)
• whether it is a formulation variation of an existing bowel-prep product or a distinct therapeutic entity
• the underlying active ingredient and whether it is generic and substitution-eligible

Without those anchors, any numerical projection (market size, share, CAGR, or revenue timing) would be fabricated.

Business-relevant implications (only what can be stated from identification constraints)

• Flavor alone is not a therapeutic differentiation in most reimbursement and guideline contexts for bowel-prep or laxative indications, unless it is tied to a distinct patentable formulation or a new regulatory submission. A projection requires knowing whether “Colyte-flavored” is:
  • a mere organoleptic change of an existing approved product, or
  • a separately authorized formulation with labeling differences.
• Clinical-trials updates are program-specific. A flavor variant can have no dedicated efficacy trials if it relies on bridging and comparability; other cases require taste acceptance and adherence endpoints. The update depends on what the regulatory strategy was for the specific product.

Key Takeaways

• “Colyte-flavored” is not identifiable as a specific drug product or clinical development program in a way that supports a data-backed clinical trials update, market analysis, or forecast.
• A correct update and projection require an unambiguous mapping to active ingredient, sponsor program, and trial identifiers.
• Without that mapping, any reported trial activity or commercial numbers would not meet standards for patent-and-clinical decision support.

FAQs

1. Can a “flavor” product name be used to update clinical trial timelines?
   No. Timelines must tie to specific program identifiers (NCT numbers, sponsor, and protocol) and a defined product label or active ingredient.

2. Do flavor changes usually create separate patent estates?
   Sometimes, if the formulation is novel and patentable (e.g., composition, stability, or process). A projection depends on whether the flavor variant is protected and separately commercialized.

3. What is typically required for a defensible market forecast for bowel-prep or GI agents?
   Indication, active ingredient, dosage form, pricing/channel, competitive set by active ingredient, and regulatory status.

4. Why can’t the clinical trial update be inferred from product naming?
   Names like “Colyte-flavored” do not uniquely identify active ingredients, sponsors, or regulatory submissions and can conflate unrelated products.

5. What would make the next update actionable?
   A concrete regulatory or clinical anchor (active ingredient plus product label/NDA or NCT-linked program).

References

[1] ClinicalTrials.gov. (n.d.). Database search and record retrieval (requires program identifiers such as NCT numbers). https://clinicaltrials.gov/
[2] FDA Drug Databases. (n.d.). Drug product and application lookup (requires NDA/ANDA/BLA or exact product identifiers). https://www.fda.gov/drugs/drug-approvals-and-databases/