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

GERD Clinical Trial

Official title:

Randomized Two-dimensional Between-patient Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose of Osteopathic Manual Therapy in Treatment of Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568825
• Other study ID #: GERD_III_2016-936
• Status: Completed
• Phase: N/A
• Start date: September 28, 2016
• Est. completion date: October 14, 2017

Study information

• Verified date: June 2018
• Source: Meddoc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 14, 2017
• Est. primary completion date: April 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• GERD

Intervention

Procedure:
• Osteopatic Manual Therapy (OMT)
OMT consisting of following interventions; thoracic spine and diaphragm mobilisation, traction of the cardia and posture correction.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meddoc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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