Treatment of Patients Suffering from Nausea/Vomiting with Dronabinol (tetrahydrocannabinol) Comparsion of three dosages versus standard therapy in a cross-over design

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000444-27-AT

Enrollment

Registered

2007-03-15

Start date

2007-04-19

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea/Vomiting of patients receiving chemotherapy MedDRA version: 9.1 Level: LLT Classification code 10036899 Term: Prophylaxis against chemotherapy induced vomiting MedDRA version: 9.1 Level: LLT Classification code 10056989 Term: Nausea post chemotherapy

Interventions

Product Name: Dronabinol(tetrahyrocannabinol) Pharmaceutical Form: Oral drops, solution INN or Proposed INN: DRONABINOL CAS Number: 1972083 Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients needing chemotherapy, for at least 5 cycles, - male or female sex, - age >= 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - pancreatic cancer - pancreatitis - patients with (suspected) ileus or other intestinal disorders, - current abdominal problems (gastritis), current bowel dysfunction - any known abuse of marijuana or a history of abuse of marijuana - life expectancy <5 months - <5 chemotherapeutic cycles expected - female subjects of child bearing potential in which a pregnancy has not been ruled out by a commercially available and routinely used urine pregnancy test (fertile women must practice adequate contraception throughout the course of the study); - serious medical illness/concomitant disease(s) which would preclude the patient from participating

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective: • final preference of a patient for a specific dose of dronabinol or standard therapy ;Secondary Objective: Secondary objectives: • comparison of nausea / vomiting-episodes as a function of the medication given / dose of dronabinol (investigators assessments) • patient’s judgement about nausea/vomiting prevention • investigator’s observations about vomiting episodes • effect on appetite of patients • effect on the body weight of patients • standard medication taken as rescue (part A) • effect on pain during study (consumption of analgesics, if applicable) • safety/tolerance, ;Primary end point(s): The primary endpoint is to determine the anti-emetic efficacy of different doses of Dronabinol in subjects receiving chemotherapy. According to the patients preference it will be evaluated if the patient prefers Dronabinol or standard therapy (i.e. the most preferred treatment).	—

Measure

Time frame

Main Objective: Primary objective: • final preference of a patient for a specific dose of dronabinol or standard therapy ;Secondary Objective: Secondary objectives: • comparison of nausea / vomiting-episodes as a function of the medication given / dose of dronabinol (investigators assessments) • patient’s judgement about nausea/vomiting prevention • investigator’s observations about vomiting episodes • effect on appetite of patients • effect on the body weight of patients • standard medication taken as rescue (part A) • effect on pain during study (consumption of analgesics, if applicable) • safety/tolerance, ;Primary end point(s): The primary endpoint is to determine the anti-emetic efficacy of different doses of Dronabinol in subjects receiving chemotherapy. According to the patients preference it will be evaluated if the patient prefers Dronabinol or standard therapy (i.e. the most preferred treatment).

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026