Advertisement

Topics

Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients

2014-08-27 03:16:22 | BioPortfolio

Summary

This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of ROSE-010 on gastric, intestinal and colonic transit and gastric volumes in female patients with C- IBS.

Description

Methodology

Female patients with C-IBS will be screened for eligibility and informed about the study at the initial screening visit Visit 1. Within two weeks of Visit 1, eligible patients will be randomized to study medication, either 30 mcg, 100 mcg or 300 mcg ROSE-010 or placebo administered via abdominal s.c injection for a total of four days, three consecutive days during transit scintigraphy and once prior to SPECT imaging. The allocation to treatment group will be concealed.

Study medication will be administered at the Charlton 7 Clinical Research Unit (CRU) at Visits 2, 3, and 4, the days of scintigraphic assessment of gastric, small bowel and colonic transit of solids performed over a 48 hour period.

Within two to seven days of Visit 4, patients will be instructed to return to the Charlton 7 CRU for administration of a final injection of study medication followed by SPECT gastric accommodation measurements (Visit 5). Within seven to ten days of Visit 5, patients will return for Visit 6, final safety monitoring and an exit interview with study staff.

Investigational product, dosage and mode of administration

Patients will receive placebo or 30 mcg, 100 mcg or 300 mcg ROSE-010 administered s.c. in the abdomen once on Visit 2, immediately before the standardized breakfast meal, fifteen minutes before the first camera image is obtained. Study medication will be administered fifteen minutes before camera images obtained on Visits 3 and 4. Study medication will be administered immediately after the first fasting scan is obtained and before the second fasting scan during SPECT at Visit 5. Study medication will be administered at Charlton 7 CRU by CRU nurses.

Duration of treatment

ROSE-010 or matching placebo will be administered via abdominal s.c injection once daily for three consecutive days and one final day two to seven days later, over a ten-day interval.

Duration of patients involvement in the study

Each patient will attend six visits at the clinic during a period of two to four weeks.

Efficacy assessments

1. Scintigraphic gastrointestinal and colonic transit

2. 99mTc SPECT measurement of gastric volumes

3. Assessment of stool frequency and consistency made by the patient using the Bowel Pattern Diary

Safety assessments

The following safety assessments will be performed:

1. Laboratory safety tests, including a complete blood count (CBC), a comprehensive metabolic panel (CMP), and urinalysis (UA) at Visit 1 (study entry) and Visit 6 (study exit)

2. A physical examination by a study physician at Visit 1

3. Weight and vital signs (including temperature, pulse, blood pressure and respiration rate) at every visit

4. Urine pregnancy tests performed at Visit 1 and within 48 hours prior to receipt of radiation at Visit 2 transit test and Visit 5 SPECT test

5. Interview for concomitant medications and adverse events at every visit

Statistical methods

An analysis of covariance (ANCOVA) will be used to compare transit parameters and gastric volumes among the treatment groups. If necessary a suitable transformation for potential skewness in the distributions of measured volumes may be used (e.g., ANCOVA on ranks or log volumes). If ANCOVA shows a p value less than or equal to 0.10, then both the 100 mcg and 300 mcg doses will be compared to placebo (p value less than or equal to 0.25). Dunnett's Test will be used to compare each dose group with placebo. Since each of the primary endpoints assesses a separate hypothesis regarding the effects of ROSE-010, no adjustment in the alpha level for testing multiple types of endpoints is anticipated, and a two-sided significance level of 0.05 will be used in each ANCOVA model.

Analysis data sets

The primary analyses will follow the intent to treat (ITT) paradigm with all patients randomized included in the analyses. Those patients with missing response values will have their missing values imputed via the overall (patients with non-missing data) mean and a corresponding adjustment in the ANCOVA residual error variance degrees of freedom (subtracting one for each missing value imputed). Safety data will be presented for all patients receiving investigational product.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Irritable Bowel Syndrome Constipation Predominant

Intervention

ROSE-010, ROSE-010, ROSE-010, Placebo

Location

Mayo Clinic Rochester
Rochester
Minnesota
United States
55905

Status

Recruiting

Source

Mayo Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:22-0400

Clinical Trials [2167 Associated Clinical Trials listed on BioPortfolio]

EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses

The objective of this paired cohort study is to evaluate the diagnostic accuracy of Endoscopic Ultrasound-fine needle aspiration (EUS-FNA) with rapid onsite evaluation (ROSE) compared to E...

Conventional Bronchoscopy Plus Rose Versus Electromagnetic Navigation (EMN) Plus Rose in Small Peripheral Lesions

The aim of this study is to evaluate if Electromagnetic navigation (ENB) in combination with rapid on site evaluation (ROSE) can improve diagnostic accuracy in those patients who fail to...

A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method

This trial compares the yield of cTBNA (conventional Transbronchial Needle Aspiration) versus the EBUS-TBNA (Endobronchial Ultrasound guided TBNA) for obtaining cytology when they are comb...

Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate (TBNA)

Purpose: Previous studies suggested an increased diagnostic yield for bronchoscopic (FB) transbronchial needle aspirate (TBNA) specimens from mediastinal lymph nodes when using rapid on-si...

Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy p...

PubMed Articles [6619 Associated PubMed Articles listed on BioPortfolio]

Factors Associated With Response to Placebo in Patients With Irritable Bowel Syndrome and Constipation.

A high proportion of patients with irritable bowel syndrome (IBS) respond to placebo in clinical trials (estimated at about 40%). We aimed to identify factors that contribute to the high placebo respo...

Rapid On-Site Evaluation of Fine-Needle Aspiration by Non-Cytopathologists: A Systematic Review and Meta-Analysis of Diagnostic Accuracy Studies for Adequacy Assessment.

Rapid on-site evaluation (ROSE) has been shown to improve adequacy rates and reduce needle passes. ROSE is often performed by cytopathologists who have limited availability and may be costlier than al...

Cloning and expression of a non-ribosomal peptide synthetase to generate blue rose.

Rose has been entwined with human culture and history. "Blue rose" in English signifies unattainable hope or impossible mission as it does not exist naturally and is not breedable regardless of centur...

Efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in a real‑world setting - results from a German noninterventional study.

 Linaclotide is a minimally absorbed peptide guanylate cyclase-C agonist approved for the treatment of irritable bowel syndrome with constipation (IBS-C). This study assessed the efficacy and tolera...

Comparison of Electroacupuncture and Mild-Warm Moxibustion on Brain-Gut Function in Patients with Constipation-Predominant Irritable Bowel Syndrome: A Randomized Controlled Trial.

To compare the effects of electroacupuncture (EA) and mild-warm moxibustion (Mox) therapies for constipation-predominant irritable bowel syndrome (C-IBS) patients.

Medical and Biotech [MESH] Definitions

A bright bluish pink compound that has been used as a dye, biological stain, and diagnostic aid.

A genus in the family PSITTACIDAE containing three species of PARAKEETS: the Derbyan, the Alexandrine, and the rose-ringed.

A plant family of the order Violales, subclass Dilleniidae, class Magnoliopsida. The common name of rock rose is used with several plants of this family.

A plant genus of the family BRASSICACEAE that is low-growing in damp meadows of the Northern Hemisphere and has pinnately divided leaves and small white to rose flowers.

The rose plant family in the order ROSALES and class Magnoliopsida. They are generally woody plants. A number of the species of this family contain cyanogenic compounds.

More From BioPortfolio on "Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Irritable Bowel Syndrome IBS
Irritable bowel syndrome (IBS) is a common but poorly understood chronic (long-term) condition where the normal functions of the bowel are disrupted. Symptoms of IBS include abdominal pain or discomfort, changes in bowel habits and bloated feelings. ...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial