Recent Updates
Recently added Catalysts

Immediate release morphine

Phase 2

Cancer | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Nov 19, 2020

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Immediate release morphine · 1 trial · 2 indications

Phase 2 1
NCT04635852Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Cancer PatientsCancer
COMPLETED10 Analytics
PHASE2COMPLETED
Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Cancer Patients
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to onset of meaningful breathlessness relief
minutes (by stop watch) from drug application of FBT/IRM up to breathlessness relief

To determine the time to onset of meaningful breathlessness relief of fentanyl buccal tablet (FBT) in comparison to immediate-release morphine (IRM)

Secondary Endpoints

Breathlessness intensity
at 0, 3, 5, 10, 15, 20, 30, 45 and 60 minutes after application of FBT/IRM
Numbers of rescue medication doses
Numbers of rescue medication doses through study completion, assessed at day 10 (final visit)
Patient's & investigator's satisfaction
through study completion, day 10 (e.g. final visit)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FentanylEXPERIMENTALFentanyl buccal tablet Dosage: 100µg - 600 µg Fentanyl (to be determined by titration) Administration: buccal administration (tablet)
Immediate release morphineACTIVE_COMPARATORImmediate release morphine, solution Dosage: Start with a minimum of 5mg (to be determined by titration)

Interventions

NameTypeDescription
FentanylDRUG -
Immediate release morphineDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: 1. Histologically or cytologically proven cancer of any entity which is non-curable as judged by the referring physician or investigator 2. To be an inpatient during the study 3. Refractory breathlessness - this study applies only to 'refractory breathlessness ' and is defined: ...

Countries:Germany
Unlock Eligibility Criteria

Frequently asked questions about Immediate release morphine

What is immediate release morphine used for in cancer?

Immediate release morphine is an investigational small molecule being studied for the relief of episodic breathlessness, also known as paroxysmal dyspnea, in cancer patients. It is currently in Phase 2 clinical development for this oncology-related condition.

Who makes immediate release morphine?

Immediate release morphine is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 2 clinical trials for cancer-related episodic breathlessness.

What phase is immediate release morphine in?

Immediate release morphine is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating episodic breathlessness in cancer patients.

What clinical trials is immediate release morphine in?

Immediate release morphine has one completed clinical trial, identified as NCT04635852. This Phase 2 study, titled 'Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Cancer Patients,' enrolled 10 participants in Germany and was an active-controlled, randomized trial.

Is immediate release morphine the same as fentanyl buccal tablet?

No, immediate release morphine is not the same as fentanyl buccal tablet. The clinical trial NCT04635852, which studied immediate release morphine, compared it against a fentanyl buccal tablet as an active control. These are two distinct drug products.