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Reboxetine

Phase 3

Fibromyalgia | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Dec 12, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment1,129

FDA Designations

No designations recorded

Clinical trial landscape

Reboxetine · 4 trials · 2 indications

Phase 3 1Phase 2 3
NCT00612170A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.Fibromyalgia
COMPLETED1,129 Analytics
PHASE3COMPLETED
A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.
FibromyalgiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in the endpoint mean pain score
14 weeks
Fibromyalgia Impact Questionnaire
14 weeks
Weekly Average Pain Score from the Daily Pain Diary.
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 5 will be calculated.

Secondary Endpoints

Change from baseline in the endpoint mean sleep interference score
14 weeks
Patient Global Impression of Change
14 weeks
Multidimensional Assessment of Fatigue
14 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
3EXPERIMENTAL -
4SHAM_COMPARATOR -
1EXPERIMENTAL -
2EXPERIMENTAL -

Interventions

NameTypeDescription
[S,S]-ReboxetineDRUG10 mg oral tablet once a day dosing
PlaceboDRUG0 mg oral tablet once a day dosing
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites145

Inclusion Criteria: * Male or female of any race, at least 18 years of age * Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) Exclusion Criteria: * Patients with other severe pain (e...

Countries:United StatesCanada
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Competitive Landscape -Fibromyalgia 5 trials

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Frequently asked questions about Reboxetine

What is Reboxetine used for?

Reboxetine is an investigational small molecule being studied for the treatment of fibromyalgia, pain, and major depressive disorder. It is being developed by Pfizer, Inc. (NYSE: PFE). The drug has completed clinical trials in these indications, including a Phase 3 study in fibromyalgia.

What does Reboxetine target?

Reboxetine is a selective norepinephrine reuptake inhibitor, meaning it works by blocking the reuptake of norepinephrine in the brain, which increases its levels. This mechanism is thought to help modulate pain pathways and improve mood, which is why it is being studied for pain conditions and depression.

Who makes Reboxetine?

Reboxetine is being developed by Pfizer, Inc., a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer has conducted multiple clinical trials of Reboxetine for pain-related conditions and fibromyalgia.

What phase is Reboxetine in?

Reboxetine has completed Phase 3 clinical development for fibromyalgia, with a large study involving 1,129 patients. It has also completed Phase 2 trials for pain conditions. However, it is not FDA approved and remains an investigational drug, as no approval status has been reported.

What clinical trials is Reboxetine in?

Reboxetine has been studied in several completed trials, including NCT00143442 for postherpetic neuralgia, NCT00288652 for pain, NCT00357825 for fibromyalgia, and NCT00612170, a Phase 3 study in fibromyalgia. All trials are completed, with no active trials currently listed.

Is Reboxetine the same as [S,S]-Reboxetine?

Yes, Reboxetine is also known as [S,S]-Reboxetine, which is the specific enantiomer used in the clinical trials. The trials listed under NCT numbers refer to [S,S]-Reboxetine, and this form is the one being investigated for pain and fibromyalgia indications.