Chemotherapy Induced Nausea and VomitingPhase 3NCT00642512
Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting
A Phase 3 study testing dronabinol, ondansetron and dronabinol/ondansetron in people with Chemotherapy Induced Nausea and Vomiting, run by Solvay Pharmaceuticals at 43 sites in United States.
Trial summary
The primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Nausea and Vomiting
- What is being tested?
- dronabinol, ondansetron and dronabinol/ondansetron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 43 sitesUnited States
- Study dates
- Jul 2003to Jul 2004
- Phase
- Phase 3
- 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
- Histological evidence of non-CNS malignancy (primary or metastatic disease) and lymphomas which are not involving the bone marrow.
- Undergoing single or multiple days of chemotherapy as long as Day 1 chemotherapy includes:
- a moderate-to-high emetogenic regimen, or
- oxaliplatin at doses employed for treatment of colon cancer, or
- the combination of AC [AdriamycinÒ (60 mg/m2) with cyclophosphamide (600 mg/m2)] as to be used for the chemotherapeutic drug regimen involving taxanes in the treatment of breast cancer.
Who cannot join
- Chemotherapy agents falling into the low (Level 1), moderate-to-low (Level 2), moderate (Level 3) unless used in combination with a Level 4 chemotherapy agent on Day 1 of the study.
- Chemotherapy agents falling into the high (Level 5) classification during study.
- Any combination of chemotherapy agents that does not fall into the moderate-to-high (Level 4) classification
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Site 950
Anaheim, California
Site 951
Arlington, Virginia
Site 902
Bismarck, North Dakota
Site 932
Boynton Beach, Florida
Site 948
Brooklyn, New York
Site 953
Brooklyn, New York
Site 918
Charleston, South Carolina
Site 917
Chattanooga, Tennessee
Site 939
Chattanooga, Tennessee
Site 944
Columbus, Ohio
Site 942
Fargo, North Dakota
Site 916
Fergus Falls, Minnesota
Site 925
Fountain Valley, California
Site 913
Greenbrae, California
Site 937
Greenwood, Mississippi
Site 928
Harvey, Illinois
Site 924
Hollywood, Florida
Site 940
Lakeland, Florida
Site 919
Little Silver, New Jersey
Site 909
Los Angeles, California
Site 922
Marietta, Georgia
Site 904
Missoula, Montana
Site 921
New Port Richey, Florida
Site 929
New Port Richey, Florida
Site 923
North Charleston, South Carolina
Site 934
Oklahoma City, Oklahoma
Site 914
Orland Park, Illinois
Site 933
Ormond Beach, Florida
Site 931
Philadelphia, Pennsylvania
Site 906
Pittsburgh, Pennsylvania
Site 908
Pomona, California
Site 943
Rancho Mirage, California
Site 926
Skokie, Illinois
Site 905
Southfield, Michigan
Site 946
Springfield, Illinois
Site 958
St Louis, Missouri
Site 956
Terre Haute, Indiana
Site 915
Texarkana, Texas
Site 910
The Bronx, New York
Site 970
Tucson, Arizona
Site 949
Valhalla, New York
Site 920
Voorhees Township, New Jersey
Site 947
Wilmington, North Carolina
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Efficacy Study of Oral Dronabinol Alone and in Combination With Ondansetron Versus Ondansetron Alone in Subjects With Delayed Chemotherapy-Induced Nausea and Vomiting
The primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following administration of moderate-to-high emetogenic chemotherapeutic agents.
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Being tested
- dronabinol, ondansetron, dronabinol/ondansetron, placebo
- Keywords
- CINV, chemotherapy, nausea, vomiting, retching
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dronabinolDrug
10 - 20 mg
ondansetronDrug
8 - 16 mg
dronabinol/ondansetronDrug
10 - 20 mg/8 - 16 mg
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: dronabinol |
| 2 | Active comparator | Not described Receives: Drug: ondansetron |
| 3 | Other | Not described Receives: Drug: dronabinol/ondansetron |
| 4 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total response of nausea and vomiting/retching was defined as no vomiting and/or retching, an intensity of nausea of < 5 mm on the visual analog scale (VAS) and no use of rescue medication.
Measured: 5 days
Secondary outcomes (4)
Complete responder rate (no vomiting/retching, intensity of nausea of ≤ 30 mm on the VAS and no use of rescue medication)
Measured: 5 days
Presence or absence of nausea
Measured: 5 days
Episodes of vomiting and/or retching
Measured: 5 days
Duration of nausea and vomiting and/or retching
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 posted25 Mar 2008 (estimated)
- Study startJul 2003
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Nausea and VomitingStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642512
- Sponsor's protocol ID
- S175.3.102
- Status last verified
- Mar 2008
- First submitted
- 21 Mar 2008
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Efficacy Study of Oral Dronabinol Alone and in Combination With Ondansetron Versus Ondansetron Alone in Subjects With Delayed Chemotherapy-Induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT00642512
- Acronym / sponsor ID
- S175.3.102
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Keywords
- CINV, chemotherapy, nausea, vomiting, retching
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 25 Mar 2008 (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.
The primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following administration of moderate-to-high emetogenic chemotherapeutic agents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: dronabinol |
| 2 | Active comparator | Drug: ondansetron |
| 3 | Other | Drug: dronabinol/ondansetron |
| 4 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological evidence of non-CNS malignancy (primary or metastatic disease) and lymphomas which are not involving the bone marrow.
- Undergoing single or multiple days of chemotherapy as long as Day 1 chemotherapy includes:
Key exclusion criteria (3 listed)
- Chemotherapy agents falling into the low (Level 1), moderate-to-low (Level 2), moderate (Level 3) unless used in combination with a Level 4 chemotherapy agent on Day 1 of the study.
- Chemotherapy agents falling into the high (Level 5) classification during study.
- Any combination of chemotherapy agents that does not fall into the moderate-to-high (Level 4) classification
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 |
|---|---|---|
| dronabinol10 - 20 mg | Drug | 1 |
| ondansetron8 - 16 mg | Drug | 2 |
| dronabinol/ondansetron10 - 20 mg/8 - 16 mg | Drug | 3 |
| placeboplacebo | Drug | 4 |
Primary outcome
Total response of nausea and vomiting/retching was defined as no vomiting and/or retching, an intensity of nausea of < 5 mm on the visual analog scale (VAS) and no use of rescue medication.
Time frame: 5 days
4 secondary outcomes
Complete responder rate (no vomiting/retching, intensity of nausea of ≤ 30 mm on the VAS and no use of rescue medication)
Time frame: 5 days
Presence or absence of nausea
Time frame: 5 days
Episodes of vomiting and/or retching
Time frame: 5 days
Duration of nausea and vomiting and/or retching
Time frame: 5 days
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 3 Apr 2008.
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dronabinol, ondansetron and dronabinol/ondansetron in people with Chemotherapy Induced Nausea and Vomiting, run by Solvay Pharmaceuticals at 43 sites in United States.
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 5 inclusion and 3 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 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Total response of nausea and vomiting/retching was defined as no vomiting and/or retching, an intensity of nausea of < 5 mm on the visual analog scale (VAS) and no use of rescue medication. (time frame: 5 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 3 Apr 2008.