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Completed

NCT Number: NCT00642512

Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset 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.

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Key information

Conditions

Chemotherapy Induced Nausea and Vomiting Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 970, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Dronabinol

Drug

10 - 20 mg

ondansetron

Drug

8 - 16 mg

dronabinol/ondansetron

Drug

10 - 20 mg/8 - 16 mg

Placebo

Drug

placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Presence or absence of nausea

    Time frame: 5 days

  3. Episodes of vomiting and/or retching

    Time frame: 5 days

  4. Duration of nausea and vomiting and/or retching

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Mar 25, 2008
Registry last updated
Apr 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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