Diabetic NeuropathiesPhase 2NCT00625833
A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
A Phase 2 study testing [S,S]-Reboxetine in people with Diabetic Neuropathies, run by Pfizer at 56 sites in 6 countries.
Trial summary
This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- [S,S]-Reboxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 56 sitesin 6 countries
- Study dates
- Dec 2007to Nov 2008
- Phase
- Phase 2
- 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
- Male or female of any race at least 18 years of age
- Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year
- Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale
Who cannot join
- Patients with significant hepatic impairment
- Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
- Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
- Amputations other than toes
- A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
- History of transient ischemic attack or stroke
- Myocardial infarction or unstable angina within the past three months
Trial locations and contacts
56 sites in 6 countries.
56 sites in 6 countries
United States32 sites
Pfizer Investigational Site
Anniston, Alabama, 36207
Pfizer Investigational Site
Bartlett, Tennessee, 38133
Pfizer Investigational Site
Beaumont, Texas, 77701
Pfizer Investigational Site
Beaumont, Texas, 77706
Pfizer Investigational Site
Birmingham, Alabama, 35235
Pfizer Investigational Site
Buffalo, New York, 14209
Pfizer Investigational Site
Cranston, Rhode Island, 02920
Pfizer Investigational Site
Cumberland, Rhode Island, 02864
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Dallas, Texas, 75390-8858
Pfizer Investigational Site
Denver, Colorado, 80209
Pfizer Investigational Site
Elizabeth, New Jersey, 07207
Pfizer Investigational Site
Hamilton, New Jersey, 08690
Pfizer Investigational Site
Houston, Texas, 77079
Pfizer Investigational Site
Houston, Texas, 77081
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Lexington, Kentucky, 40503
Pfizer Investigational Site
Louisville, Kentucky, 40213
Pfizer Investigational Site
Marionville, Missouri, 65705
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Mission Viejo, California, 92691
Pfizer Investigational Site
Myrtle Beach, South Carolina, 29572
Pfizer Investigational Site
New Britain, Connecticut, 06050
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
New York, New York, 10024
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
Tampa, Florida, 33609
Pfizer Investigational Site
Tupelo, Mississippi, 38801
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
Winter Haven, Florida, 33880
South Africa7 sites
Pfizer Investigational Site
Bloemfontein, Free State, 9301
Pfizer Investigational Site
Cape Town, 7130
Pfizer Investigational Site
Durban, KwaZulu-Natal, 4000
Pfizer Investigational Site
Ennerdale, Gauteng, 1820
Pfizer Investigational Site
KwaDukuza, KwaZulu-Natal, 4450
Pfizer Investigational Site
Pretoria, Gauteng, 0204
Pfizer Investigational Site
Worcester, Cape Town, 6850
Spain6 sites
Pfizer Investigational Site
Barcelona, 08035
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, 28040
Pfizer Investigational Site
Pontevedra, 36071
Pfizer Investigational Site
Santiago de Compostela, LA Coruña, 15706
Pfizer Investigational Site
Valencia, 46014
Czechia4 sites
Pfizer Investigational Site
Brno, 636 00
Pfizer Investigational Site
České Budějovice, 370 87
Pfizer Investigational Site
Ostrava, 702 00
Pfizer Investigational Site
Zlín, 760 01
Finland4 sites
Pfizer Investigational Site
Helsinki, 00290
Pfizer Investigational Site
Kokkola, 67100
Pfizer Investigational Site
Lahti, 15110
Pfizer Investigational Site
Lohja, 08200
Netherlands3 sites
Pfizer Investigational Site
Almere Stad, 1311 RL
Pfizer Investigational Site
Amsterdam, 1105 AZ
Pfizer Investigational Site
Venlo, 5912 BL
About this study
Official title: A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.
- Conditions
- Diabetic Neuropathies
- Being tested
- Placebo, [S,S]-Reboxetine
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral tablet once a day dosing for 10 weeks.
[S,S]-ReboxetineDrug
Oral tablet once a day dosing for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: [S,S]-Reboxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weekly average pain score
Measured: 8 weeks
Secondary outcomes (4)
Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score)
Measured: 8 weeks
Change from baseline in weekly average sleep interference scale
Measured: 8 weeks
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory
Measured: 8 weeks
Modified Brief Pain Inventory-Short Form
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Study was terminated for futility following the planned interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625833
- Sponsor's protocol ID
- A6061037
- Status last verified
- Dec 2019
- First submitted
- 14 Feb 2008
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
- ClinicalTrials.gov ID
- NCT00625833
- Acronym / sponsor ID
- A6061037
- Conditions
- Diabetic Neuropathies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated for futility following the planned interim analysis.
- Enrolment
- 330 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 28 Feb 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.
This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: [S,S]-Reboxetine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female of any race at least 18 years of age
- Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year
- Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale
Key exclusion criteria (7 listed)
- Patients with significant hepatic impairment
- Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
- Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
- Amputations other than toes
- A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
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 |
|---|---|---|
| PlaceboOral tablet once a day dosing for 10 weeks. | Drug | Placebo |
| [S,S]-ReboxetineOral tablet once a day dosing for 10 weeks. | Drug | 2 |
Primary outcome
Change from baseline in weekly average pain score
Time frame: 8 weeks
4 secondary outcomes
Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score)
Time frame: 8 weeks
Change from baseline in weekly average sleep interference scale
Time frame: 8 weeks
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory
Time frame: 8 weeks
Modified Brief Pain Inventory-Short Form
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Study was terminated for futility following the planned interim analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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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.
Pfizer CT.gov Call Center study director
Pfizer
56 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [S,S]-Reboxetine in people with Diabetic Neuropathies, run by Pfizer at 56 sites in 6 countries.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, South Africa, Spain, Czechia, Finland and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Study was terminated for futility following the planned interim analysis.). Results are not available in the source record.
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?
Change from baseline in weekly average pain score (time frame: 8 weeks). 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 13 Dec 2019.