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

NCT ID: NCT03568825

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-28
• Study Completion Date: 2017-10-14

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.

Conditions

GERD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Number of Osteopatic Manual Therapy

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

Group Type: EXPERIMENTAL

Osteopatic Manual Therapy (OMT)

Intervention Type: PROCEDURE

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

Interval in days between each 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.

Group Type: EXPERIMENTAL

Osteopatic Manual Therapy (OMT)

Intervention Type: PROCEDURE

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

Interventions

Osteopatic Manual Therapy (OMT)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meddoc

OTHER

Sponsor Role: lead

Responsible Party

Prof Stig Larsen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stig E Larsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Univesity of Life Sciences

Other Identifiers

GERD_III_2016-936

Identifier Type: -

Identifier Source: org_study_id