Diabetic NeuropathiesPhase 3NCT00283842
Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
A Phase 3 study testing DVS SR in people with Diabetic Neuropathies and Pain, run by Wyeth is now a wholly owned subsidiary of Pfizer at 51 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathies, Pain
- What is being tested?
- DVS SR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- 51 sitesUnited States
- Study dates
- Mar 2006to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diabetes type 1 or 2
- Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months
Who cannot join
- Major Depression
- Uncontrolled diabetes
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Study site
Albany, New York, 12205
Study site
Ann Arbor, Michigan, 48106
Study site
Austin, Texas, 78705
Study site
Billings, Montana, 59101
Study site
Chicago, Illinois, 60610
Study site
Cincinnati, Ohio, 45236
Study site
Coeur d'Alene, Idaho, 83814
Study site
Collegeville, Pennsylvania, 19426
Study site
Dallas, Texas, 75246
Study site
Dayton, Ohio, 45432
Study site
Des Moines, Iowa, 50314
Study site
Encino, California, 91316
Study site
Evansville, Indiana, 47714
Study site
Fargo, North Dakota, 58104
Study site
Feasterville, Pennsylvania, 19053
Study site
Flushing, New York, 11365
Study site
Fort Myers, Florida, 33907
Study site
Harleysville, Pennsylvania, 19438
Study site
Kansas City, Missouri, 64114
Study site
Lakewood, Washington, 98499
Study site
Lawrenceville, Georgia, 30045
Study site
Madisonville, Kentucky, 42431
Study site
Mesa, Arizona, 85210
Study site
Midvale, Utah, 84047
Study site
Milwaukee, Wisconsin, 53209
Study site
New Britain, Connecticut, 06050
Study site
New York, New York, 10024
Study site
Newport Beach, California, 92660
Study site
Omaha, Nebraska, 88131
Study site
Palm Beach Gardens, Florida, 33418
Study site
Pembroke Pines, Florida, 33026
Study site
Peoria, Arizona, 85381
Study site
Phoenix, Arizona, 85016
Study site
Pueblo, Colorado, 81001
Study site
Rochester, New York, 14621
Study site
Roswell, Georgia, 30076
Study site
Salt Lake City, Utah, 84106
Study site
San Antonio, Texas, 78229
Study site
Springfield, Massachusetts, 01199
Study site
St Louis, Missouri, 63117
Study site
St Louis, Missouri, 63141
Study site
St. Petersburg, Florida, 33709
Study site
Staten Island, New York, 10312
Study site
Stratford, Connecticut, 06615
Study site
Tacoma, Washington, 98405
Study site
Toledo, Ohio, 43623
Study site
Virginia Beach, Virginia, 23451
Study site
Walnut Creek, California, 94598
Study site
Warwick, Rhode Island, 02886
Study site
Waterbury, Connecticut, 06708
Study site
West Palm Beach, Florida, 33401
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
- Conditions
- Diabetic Neuropathies, Pain
- Being tested
- DVS SR, Placebo
- Keywords
- neuropathic pain, diabetic peripheral neuropathy
- Medical subject headings
- Diabetic Neuropathies, Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVS SRDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| desvenlafaxine succinate sustained-release (DVS SR) 50mg | Experimental | Not described Receives: Drug: DVS SR |
| desvenlafaxine succinate sustained-release (DVS SR) 100mg | Experimental | Not described Receives: Drug: DVS SR |
| desvenlafaxine succinate sustained-release (DVS SR) 200mg | Experimental | Not described Receives: Drug: DVS SR |
| desvenlafaxine succinate sustained-release (DVS SR) 400mg | Experimental | Not described Receives: Drug: DVS SR |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Pain Severity Score From Baseline to 13 Weeks
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.
Measured: Baseline and 13 weeks
Secondary outcomes (1)
Number of Patients With ≥50% Reduction in Mean Pain Severity Score.
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline.
Measured: Baseline and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283842
- Sponsor's protocol ID
- 3151A5-322
- Status last verified
- Oct 2011
- First submitted
- 26 Jan 2006
- Last updated
- 24 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Allen R, Sharma U, Barlas S. Clinical experience with desvenlafaxine in treatment of pain associated with diabetic peripheral neuropathy. J Pain Res. 2014 Jun 23;7:339-51. doi: 10.2147/JPR.S55682. eCollection 2014.
PubMed 25018648
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00283842
- Acronym / sponsor ID
- 3151A5-322
- Conditions
- Diabetic Neuropathies, Pain
- Keywords
- neuropathic pain, diabetic peripheral neuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business reasons
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 30 Jan 2006 (estimated)
- Results
- Posted 13 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| desvenlafaxine succinate sustained-release (DVS SR) 50mg | Experimental | Drug: DVS SR |
| desvenlafaxine succinate sustained-release (DVS SR) 100mg | Experimental | Drug: DVS SR |
| desvenlafaxine succinate sustained-release (DVS SR) 200mg | Experimental | Drug: DVS SR |
| desvenlafaxine succinate sustained-release (DVS SR) 400mg | Experimental | Drug: DVS SR |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes type 1 or 2
- Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months
Key exclusion criteria (2 listed)
- Major Depression
- Uncontrolled diabetes
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 |
|---|---|---|
| DVS SR | Drug | desvenlafaxine succinate sustained-release (DVS SR) 100mg, desvenlafaxine succinate sustained-release (DVS SR) 200mg, desvenlafaxine succinate sustained-release (DVS SR) 400mg, desvenlafaxine succinate sustained-release (DVS SR) 50mg |
| Placebo | Drug | Placebo |
Primary outcome
Change in Mean Pain Severity Score From Baseline to 13 Weeks
Time frame: Baseline and 13 weeks
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.
1 secondary outcome
Number of Patients With ≥50% Reduction in Mean Pain Severity Score.
Time frame: Baseline and 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25018648Allen R, Sharma U, Barlas S. Clinical experience with desvenlafaxine in treatment of pain associated with diabetic peripheral neuropathy. J Pain Res. 2014 Jun 23;7:339-51. doi: 10.2147/JPR.S55682. eCollection 2014.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DVS SR in people with Diabetic Neuropathies and Pain, run by Wyeth is now a wholly owned subsidiary of Pfizer at 51 sites in United States.
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 2 inclusion and 2 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 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Mean Pain Severity Score From Baseline to 13 Weeks (time frame: Baseline and 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00283842, which also lists 1 linked publication.
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 24 Oct 2011.