EmesisPhase 2COMFORTNCT01148264
Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis
A Phase 2 study testing olanzapine and metoclopramide in people with Emesis, run by Karin Jordan at 1 site in Germany.
Trial summary
This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emesis
- What is being tested?
- olanzapine and metoclopramide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Oct 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea>25mm on VAS
- signed IC
Who cannot join
- psychiatric disorders
- drug abuse
- pregnancy
- high dose chemotherapy
- treatment with other antiemetic drugs
Trial locations and contacts
1 site in 1 country.
Germany1 site
Martin-Luther-University Halle-Wittenberg, Department for Oncology and Hematology, Ernst-Grube-Strasse 40
Halle, Saxony-Anhalt, 06097
About this study
Official title: Efficacy of Olanzapine in Break-through Emesis After Prophylaxis With Dexamethasone, 5-HT3 Receptor Antagonists and Aprepitant Compared to Metoclopramide
This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.
- Conditions
- Emesis
- Being tested
- olanzapine, metoclopramide
- Keywords
- break-through, emesis, break through emesis after prophylaxis with dexamethasone, 5-HT 3RA and aprepitant
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
Also called Zyprexa
1x10mg per day for three days
metoclopramideDrug
Also called Paspertin
3x10mg per day for three days
| Study group | Role | What they receive |
|---|---|---|
| olanzapine | Experimental | Not described Receives: Drug: olanzapine |
| metoclopramide | Active comparator | Not described Receives: Drug: metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate
no vomitus, no further rescue medication, nausea < 25mm on the visual analog scale (VAS) or reduction on the VAS of >50%
Measured: three days
Secondary outcomes (3)
safety
according to NCI-CTC-AE version4.0
Measured: five days
Quality of life
using EORTC-QLQ-C30
Measured: 5 days
change in urinary excretion of 5 hydroxy indole acetic acid
measurement in 24 hours urine samples
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2013
- Study completionOct 2014
Why it stopped: poor enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmesisStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karin Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karin Jordan, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Karin Jordan, MD, Principal investigator, Martin-Luther-University Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148264
- Sponsor's protocol ID
- KKSH 079
- Other IDs
- 2010-018665-30
- Acronym
- COMFORT
- Status last verified
- May 2016
- First submitted
- 21 Jun 2010
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Olanzapine in Break-through Emesis After Prophylaxis With Dexamethasone, 5-HT3 Receptor Antagonists and Aprepitant Compared to Metoclopramide
- ClinicalTrials.gov ID
- NCT01148264
- Acronym / sponsor ID
- COMFORT / KKSH 079
- Conditions
- Emesis
- Keywords
- break-through, emesis, break through emesis after prophylaxis with dexamethasone, 5-HT 3RA and aprepitant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrolment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Karin JordanUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Jun 2010 (estimated)
- 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.
This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olanzapine | Experimental | Drug: olanzapine |
| metoclopramide | Active comparator | Drug: metoclopramide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea>25mm on VAS
- signed IC
Key exclusion criteria (5 listed)
- psychiatric disorders
- drug abuse
- pregnancy
- high dose chemotherapy
- treatment with other antiemetic drugs
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 |
|---|---|---|
| olanzapineAlso: Zyprexa1x10mg per day for three days | Drug | olanzapine |
| metoclopramideAlso: Paspertin3x10mg per day for three days | Drug | metoclopramide |
Primary outcome
Clinical benefit rate
Time frame: three days
no vomitus, no further rescue medication, nausea < 25mm on the visual analog scale (VAS) or reduction on the VAS of >50%
3 secondary outcomes
safety
Time frame: five days
Quality of life
Time frame: 5 days
change in urinary excretion of 5 hydroxy indole acetic acid
Time frame: 5 days
Results and safety
The study was stopped early (reason given: poor enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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Nausea, Vomiting
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.
Karin Jordan, MD principal investigator
Martin-Luther-University Halle-Wittenberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing olanzapine and metoclopramide in people with Emesis, run by Karin Jordan at 1 site in Germany.
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 5 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: stopped early, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor enrolment). Results are not available in the source record.
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?
Clinical benefit rate (time frame: three days). 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 11 May 2016.