Clinical trial NCT03568825: Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD
Keywords: Two-dimensional randomized response surface pathway design
Osteopathic Manual Therapy
OMT in treatment of GERD
Dose-response
Lead sponsor: Meddoc
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Percent reduction in sum of the five GERD score from baseline.
timeFrame: One week after last OMT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian Univesity of Life Sciences
name: Stig E Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: