Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose

NCT03568825 | Completed DMC

• 1 other identifier: GERD_III_2016-936
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Response Surface Pathway (RSP) design was previously developed for dose-finding studies with one interventional and one response variable, but RSP to higher dimensions is requested. The aim of this study is to introduce and evaluate the RSP design with two interventional and one response variable exemplified by estimating Minimum Efficacy Dose (MED) of Osteopathic Manual Therapy (OMT) in treatment of gastroesophageal reflux disease (GERD).

Conditions

GERD

Keywords

Two-dimensional randomized response surface pathway design; Osteopathic Manual Therapy; OMT in treatment of GERD; Dose-response

Outcome Measures

Primary Outcomes (1)

• Percent reduction in sum of the five GERD score from baseline.

  The five GERD variables recorded at baseline and one week after the last treatment were degrees of "Heartburn", "Chest pain", "Acid in mouth", "Epigastric pain" and "Thoracic pain", each recorded on a 10 cm VAS. The response variables were percent reduction in sum of the five GERD variables from baseline.

  One week after last OMT

Study Arms (2)

Number of Osteopatic Manual Therapy

EXPERIMENTAL

Intervention: OMT. Osteopatic Manual treatment consisting of Thoracic spine, Diaphragm mobilisation, Traction of the cardia and posture correction.

Procedure: Osteopatic Manual Therapy (OMT)

Interval in days between each OMT

EXPERIMENTAL

Intervention: OMT. The time between each OMT's is calculated by the study design. Each OMT intervantion consists of Thoracic spine and Diaphragm mobilisation, Traction of the cardia and Posture correction.

Procedure: Osteopatic Manual Therapy (OMT)

Interventions

Osteopatic Manual Therapy (OMT) PROCEDURE

OMT consisting of following interventions; thoracic spine and diaphragm mobilisation, traction of the cardia and posture correction.

Interval in days between each OMT; Number of Osteopatic Manual Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosed Gastroesophigual Reflux Disease
• Known effect of anti-reflux medication

You may not qualify if:

• Hiatus hernia ≥5 cm
• gastric ulcer
• cancer
• uncontrolled bacterial, viral, fungal or parasite infection.

Sponsors & Collaborators

• Meddoc: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Stig E Larsen, PhD

  Norwegian Univesity of Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study is a RSP designed multicenter study with two interventional- and one response variable. The two-interventional variable were Number of OMTs and Interval in days between each treatment. The GERD variables were degrees of Heartburn, Chest pain, Acid in mouth, Epigastric pain and "Thoracic pain". The response variable were percent reduction in sum of the GERD variables from baseline in 4 categories. Each of the two RSP designs consisted of three dose levels. Three GERD patients were allocated to the first design level given six OMT with five days' interval. Based on the results obtained from the first design level, five patients were subsequently included to the second design level. The number of OMT's and interval between each treatment was separately determined. Seven patients were included to the third design level and given number of OMT's and interval between treatments calculated based on results obtained from the second design level.

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 26, 2018
• Study Start: September 28, 2016
• Primary Completion: April 24, 2017
• Study Completion: October 14, 2017
• Last Updated: June 26, 2018

Record last verified: 2018-06