Participant will receive a blueberry drink containing 18 g of fructose and 14 g of glucose.

Participant will receive a blueberry drink and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)

Participant will receive a Soft beverage (Coca-cola containing 17,5 g fructose and 17,5 g glucose)

Participant will receive a Soft beverage and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)

Participant will receive a drink containing 35 g of fructose

Participant will receive a drink containing 35 g of fructose and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)

Chronic Kidney Diseases

Diabetes Mellitus, Type 2

Blueberry drink

Participant receive blueberry drink and a slice of pizza

Blueberry and pizza

Participant receive a soft beverage drink

Soft beverage

Participant receive a soft beverage drink and a slice of pizza

Soft beverage and pizza

Participant receive a drink containing fructose

Fructose

Participant receive a fructose drink and a slice of pizza

Fructose and pizza

Karolinska University Hospital

Effect of Acute Fructose Load in Human

The Effect of Acute Fructose Load in Patients With Chronic Kidney Disease and Patients With Type 2 Diabetes Compared to Healthy Subjects

Change in uric acid after intervention compared to the levels Before the intervention

Neda Rajamand Ekberg

M.D.,Ph.D

Interventional study. Participant will on sex different occasions receive drinks containing fructose (fructose drink, coca-cola or blueberry drink) with and without the addition of a high-fat meal

Sjogren's Syndrome

National Institute of Dental And Craniofacial Research (NIDCR)

The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers

Basal and Stimulated Somatostatin Plasma Levels in Patients With Primary Sjogren's Syndrome and in Control Subjects

National Institute of Dental and Craniofacial Research (NIDCR)

GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)

GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)

GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)

Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)

GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water

GIC-1001 Low Dose

GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water

GIC-1001 Mid-dose

GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water

GIC-1001 , High Dose

Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water

GIC-1001 Matching Placebo

Total

Sex: Female, Male

Race/Ethnicity, Customized

The Primary Outcomes Measure was the pain VAS 100-mm AUC (0mm = no pain; 100mm = worst pain), constructed from serial pain VAS measurements performed during colonoscopy. At least 8 pain VAS measurements were made, and the length of the colonoscope inserted (or removed on the way out) was recorded at every measurement. The X-axis of the VAS versus anatomical locations was defined accordingly: each VAS value corresponded to a relative length of inserted colonoscope (d/2Lc) of the X axis, where d was the actual length of the inserted colonoscope and 2Lc represented twice the total length of the colon examined (Lc). Before scope insertion the X value equaled zero. Once the caecum was reached, the X value was 0.5. Upon complete removal of the endoscope, the X value was 1. This allowed standardization of colonic length between study subjects. Visceral pain AUC (mm) was calculated from all serial measurements, where the length of inserted colonoscope determined the VAS measurement's location

Measurements of Visceral Pain, Using a 100-mm Visual Analog Scale (VAS)

Time to Caecum is the time taken by the physician to reach the caecum with the colonoscope, from the insertion in the anus. Time to Caecum was measured during colonoscopy, for which total duration of colonoscopy ranged between a minimum of 5.00 and a maximum of 50.10 minutes.

Time to Caecum

Qualitative outcome: colonoscopy completion is defined as a procedure performed entirely, from initial anal insertion, reaching of caecum, and complete removal of the scope. Completion rate is then the number of patient (%) with a complete colonoscopy (up to the caecum) divided by the number of trial participants.

Colonoscopy Completion Rate (%)

A pharmacokinetic (PK) analysis was carried out on the first 24 patients randomized, equally distributed between treatment groups; 18 patients were assigned to active treatment

Safety-Plasma Concentrations of Trimebutine and N-Desmethyl-Trimebutine

Defined as the time from endoscope insertion to complete removal of the endoscope; measured in minutes

Total Examination Time (Colonoscopy)

Endoscopist's perception of the adequacy of analgesia, difficulty of insertion and withdrawal measured on a five-point Likert scale: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree

Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal

Endoscopist's perception of the amount of colonic spasm on insertion and withdrawal measured on five-point Likert scale according to the following: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree

Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal

Patients' willingness for repeat colonoscopy, was assessed with the Patient Willingness to Repeat Experience (P.W.R.E.) questionnaire (1 question), asking patients to rate their willingness to repeat the procedure according to a 5-point Likert scale: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree. The P.W.R.E was administered after the colonoscopy during subject recovery.

Patient's Willingness to Repeat Experience

Subject satisfaction and acceptability of the colonic analgesia modality offered by GIC-1001 was assessed with the Patient Global Impression of Abdominal Pain (P.G.I.A.P.) (1 question), asking patients to rate their pain during the procedure according to a 5-point Likert scale: Absent, Mild, Moderate, Severe, Intolerable. The P.G.I.A.P was administered after the colonoscopy during subject recovery.

Subject Satisfaction and Acceptability of the Colonic Analgesia - Patient's Global Impression of Abdominal Pain

Overall Study

Patrick Colin

Pain

Cancer

Colonic Diseases

GIC-1001 oral tablet, white-coated, to be taken with water

GIC-1001

Mayo Clinic

Anaheim Clinical Trials

Precision Research Institute

Avail Clinical Research LLC

The Center for GI Disorders

Mid-Atlantic Medical Research Centers

Mayo Clinic Rochester

PharmaTrials

Montefiore Medical Center

Gastroenterology Associates of Orangeburg

GIRI (GI Research Institute)

Toronto Digestive Disease Associates

Clinique 1037

Spécialistes MD Specialists

A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Proof-of-Concept Study of GIC-1001 for the Management of Visceral Pain in Subjects Undergoing Sedation-Free, Full Colonoscopy

gicare Pharma Inc.

JSS Medical Research Inc.

Algorithme Pharma Inc

25 patients after elective colorectal surgery will be given 100 mg caffeine citrate orally diluted in 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

25 patients after elective colorectal surgery will be given 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

Postoperative Ileus

Caffeine Citrate

Water

Ref 11. Mayo Clinic staff. Caffeine content for coffee, tea, soda and more. [Accessed March 14, 2017]

Hadassah Medical Organization

Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

The time in hours from end of surgery to first flatus.

The time in hours from end of surgery to first bowel movement.

The time in hours from end of surgery to first solid meal tolerated (the first time the patient is able to eat any food requiring chewing, without vomiting or going back to liquid diet)

The postoperative hospital stay is the number of hours from surgery until discharge. The criteria for hospital discharge include stable vital signs with no febrile morbidity for ≥24 hours, passage of stool, toleration of a solid diet and the absence of other complications.

cola/抗炎症薬

Effect of Acute Fructose Load in Human

The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers

A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy

Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

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