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

Not Applicable

Completed

• Conditions: GERD
• Interventions: Procedure: Osteopatic Manual Therapy (OMT)

• Registration Number: NCT03568825
• Lead Sponsor: Meddoc

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).

Detailed Description

15 GERD patients, divided in three design-level with three, five and seven patients. The study was performed as a two-dimensional randomized, between-patient RSP designed multicenter study with two interventional- and one response variable. The interventional variables "Number of OMT's" and "Treatment Interval" with common response variable formed two independent one-dimensional randomized between-patient RSP studies. The response variable was the percent reduction in sum of the five GERD score from baseline. Three GERD patients were allocated on the first design level given six OMT with five days' interval. Based on results obtained in the first and second design level, five patients were included to the second design level and seven to the third.

Study Timeline

• Study Start: 2016-09-28
• Primary Completion: 2017-04-24
• Study Completion: 2017-10-14
• Status Verified: 2018-06
• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-22
• Last Update Submitted: 2018-06-22
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Number of Osteopatic Manual Therapy	Osteopatic Manual Therapy (OMT)	Intervention: OMT. Osteopatic Manual treatment consisting of Thoracic spine, Diaphragm mobilisation, Traction of the cardia and posture correction.
Interval in days between each OMT	Osteopatic Manual Therapy (OMT)	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.

Primary Outcome Measures

Name	Time	Method
Percent reduction in sum of the five GERD score from baseline.	One week after last OMT	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.