GERDNCT03568825
Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose
A study testing Osteopatic Manual Therapy (OMT) in people with GERD, run by Meddoc.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GERD
- What is being tested?
- Osteopatic Manual Therapy (OMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2016to 14 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosed Gastroesophigual Reflux Disease
- Known effect of anti-reflux medication
Who cannot join
- Hiatus hernia ≥5 cm
- gastric ulcer
- cancer
- uncontrolled bacterial, viral, fungal or parasite infection.
About this study
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
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).
Read the 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
- Being tested
- Osteopatic Manual Therapy (OMT)
- Keywords
- Two-dimensional randomized response surface pathway design, Osteopathic Manual Therapy, OMT in treatment of GERD, Dose-response
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopatic Manual Therapy (OMT)Procedure or surgery
OMT consisting of following interventions; thoracic spine and diaphragm mobilisation, traction of the cardia and posture correction.
| Study group | Role | What they receive |
|---|---|---|
| Number of Osteopatic Manual Therapy | Experimental | Intervention: OMT. Osteopatic Manual treatment consisting of Thoracic spine, Diaphragm mobilisation, Traction of the cardia and posture correction. Receives: 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. Receives: Procedure: Osteopatic Manual Therapy (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week after last OMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start28 Sep 2016
- Primary completion24 Apr 2017
- Study completion14 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meddoc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Stig Larsen, Meddoc
- Investigators
- Stig E Larsen, PhD, Principal investigator, Norwegian Univesity of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568825
- Sponsor's protocol ID
- GERD_III_2016-936
- Status last verified
- Jun 2018
- First submitted
- 13 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03568825
- Acronym / sponsor ID
- GERD_III_2016-936
- Conditions
- GERD
- Keywords
- Two-dimensional randomized response surface pathway design, Osteopathic Manual Therapy, OMT in treatment of GERD, Dose-response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MeddocUniversity, hospital or other
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 14 Oct 2017 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Number of Osteopatic Manual Therapy | Experimental | Procedure: 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 | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosed Gastroesophigual Reflux Disease
- Known effect of anti-reflux medication
Key exclusion criteria (4 listed)
- Hiatus hernia ≥5 cm
- gastric ulcer
- cancer
- uncontrolled bacterial, viral, fungal or parasite infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopatic Manual Therapy (OMT)OMT consisting of following interventions; thoracic spine and diaphragm mobilisation, traction of the cardia and posture correction. | Procedure or surgery | Interval in days between each OMT, Number of Osteopatic Manual Therapy |
Primary outcome
Percent reduction in sum of the five GERD score from baseline.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stig E Larsen, PhD principal investigator
Norwegian Univesity of Life Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Osteopatic Manual Therapy (OMT) in people with GERD, run by Meddoc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in sum of the five GERD score from baseline. (time frame: One week after last OMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.