PainPhase 2NCT00348894
[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.
A Phase 2 study testing [S,S]-Reboxetine and Any in people with Pain, run by Pfizer at 93 sites in 14 countries.
Trial summary
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- [S,S]-Reboxetine and Any
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 93 sitesin 14 countries
- Study dates
- Jul 2006to Oct 2007
- 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
- Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy
- Patients at screening must have a score >/=40 mm on the pain visual analogue scale
Who cannot join
- Patients with significant hepatic impairment
- Patients with other severe pain, that may impair the self-assessment of the pain due to DPN
Trial locations and contacts
93 sites in 14 countries.
93 sites in 14 countries
United States24 sites
Pfizer Investigational Site
Auburn, California, 95602
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Columbia, Missouri, 65212
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Greensboro, North Carolina, 27408
Pfizer Investigational Site
Honululu, Hawaii, 96814
Pfizer Investigational Site
Huntington Beach, California, 92648
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Las Vegas, Nevada, 89148
Pfizer Investigational Site
Naples, Florida, 34102
Pfizer Investigational Site
Nashua, New Hampshire, 03063
Pfizer Investigational Site
Omaha, Nebraska, 68105
Pfizer Investigational Site
Orangevale, California, 95662
Pfizer Investigational Site
Phoenix, Arizona, 85050
Pfizer Investigational Site
Reno, Nevada, 89509
Pfizer Investigational Site
Richmond, Virginia, 23225
Pfizer Investigational Site
Scottsdale, Arizona, 85254
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Winter Park, Florida, 32789
South Africa9 sites
Pfizer Investigational Site
Durban, KwaZulu-Natal, 4000
Pfizer Investigational Site
Durban, Overport, 4091
Pfizer Investigational Site
Durban, 4001
Pfizer Investigational Site
Durban, 4091
Pfizer Investigational Site
Houghton, Johannesburg, 2198
Pfizer Investigational Site
Johannesburg, Gauteng, 1827
Pfizer Investigational Site
Parktown, Gauteng, 2193
Pfizer Investigational Site
Pretoria, 0001
Pfizer Investigational Site
Soweto, 6201
Germany7 sites
Pfizer Investigational Site
Bad Mergentheim, 97980
Pfizer Investigational Site
Mainz, 55116
Pfizer Investigational Site
Meissen, 01662
Pfizer Investigational Site
Münster, 48145
Pfizer Investigational Site
St.Ingbert, 66386
Pfizer Investigational Site
Tann I.d. Rhoen, 36142
Pfizer Investigational Site
Würzburg, 97072
Canada6 sites
Pfizer Investigational Site
Laval, Quebec, H7T 2P5
Pfizer Investigational Site
Montreal, Quebec, H3A 1A1
Pfizer Investigational Site
Ottawa, Ontario, K1H 1A2
Pfizer Investigational Site
Toronto, Ontario, M3H 5S4
Pfizer Investigational Site
Toronto, Ontario, M5G 2N2
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4
India6 sites
Pfizer Investigational Site
Ansārinagar, New Delhi, 110 029
Pfizer Investigational Site
Bangalore, Karnataka, 560 054
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 033
Pfizer Investigational Site
Ludhiana, 141 001
Pfizer Investigational Site
Maharashtra, Mumbai, 400 007
Pfizer Investigational Site
Vellore, 632 004
Poland6 sites
Pfizer Investigational Site
Bytom, 41-902
Pfizer Investigational Site
Łask, 98-100
Pfizer Investigational Site
Lodz, 93-338
Pfizer Investigational Site
Lublin, 20-536
Pfizer Investigational Site
Otwock, 05-400
Pfizer Investigational Site
Wroclaw, 50-088
Argentina5 sites
Pfizer Investigational Site
Buenos Aires, C1034ACO
Pfizer Investigational Site
Buenos Aires, C1181ACH
Pfizer Investigational Site
Buenos Aires, C1280AEB
Pfizer Investigational Site
Buenos Aires, C1405CWB
Pfizer Investigational Site
Buenos Aires, C1426ABP
Estonia5 sites
Pfizer Investigational Site
Pärnu, 80018
Pfizer Investigational Site
Tallinn, 13419
Pfizer Investigational Site
Tartu, 50406
Pfizer Investigational Site
Tartu, 51014
Pfizer Investigational Site
Viljandi Mk., 71024
Sweden5 sites
Pfizer Investigational Site
Gothenburg, 40014
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Gothenburg, 417 17
Pfizer Investigational Site
Stockholm, 115 22
Pfizer Investigational Site
Umeå, S-901 85
Ukraine5 sites
Pfizer Investigational Site
Dnipropetrovsk, 49600
Pfizer Investigational Site
Donetsk, 84003
Pfizer Investigational Site
Kharkiv, 61070
Pfizer Investigational Site
Kyiv, 02091
Pfizer Investigational Site
Odesa, 65009
United Kingdom5 sites
Pfizer Investigational Site
Bath, BA1 3NG
Pfizer Investigational Site
Carshalton, Surrey, SM5 1AA
Pfizer Investigational Site
Dundee, DD1 9SY
Pfizer Investigational Site
London, SE5 9RS
Pfizer Investigational Site
Manchester, M13 9WL
Finland4 sites
Pfizer Investigational Site
Helsinki, 00150
Pfizer Investigational Site
Oulu, 90100
Pfizer Investigational Site
Seinäjoki, 60220
Pfizer Investigational Site
Tampere, 33520
Russia4 sites
Pfizer Investigational Site
Moscow, 119021
Pfizer Investigational Site
Moscow, 123423
Pfizer Investigational Site
Saint Petersburg, 194354
Pfizer Investigational Site
Saint Petersburg, 197022
Croatia2 sites
Pfizer Investigational Site
Osijek, 31000
Pfizer Investigational Site
Split, 21000
About this study
Official title: A Phase 2b Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Chronic Painful Diabetic Peripheral Neuropathy (DPN).
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy
- Conditions
- Pain
- Being tested
- [S,S]-Reboxetine, Any
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[S,S]-ReboxetineDrug
[S,S]-reboxetine
AnyDrug
Any standard of care treatment for DPN
| Study group | Role | What they receive |
|---|---|---|
| Open Treatment | Experimental | [S,S]-reboxetine Receives: Drug: [S,S]-Reboxetine |
| Standard Care | Other | Standard Care Receives: Drug: Any |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs
Measured: duration of study
Physical examination
Measured: duration of study
12-lead ECG
Measured: duration of study
Hematology/Biochemistry
Measured: duration of study
Adverse events
Measured: duration of study
Secondary outcomes (8)
Pain Visual Analogue Scale
Measured: duration of study
Neuropathic Pain Symptom Inventory
Measured: duration of study
Modified Brief Pain Inventory-Short Form
Measured: duration of study
Patient Global Impression of Change
Measured: duration of study
SF-12 Health Survey
Measured: duration of study
EQ-5D
Measured: duration of study
Analgesic Treatment Satisfaction Scale
Measured: duration of study
Pain-related Medication Utilization
Measured: duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: \- Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348894
- Sponsor's protocol ID
- A6061031
- Status last verified
- May 2011
- First submitted
- 4 Jul 2006
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Chronic Painful Diabetic Peripheral Neuropathy (DPN).
- ClinicalTrials.gov ID
- NCT00348894
- Acronym / sponsor ID
- A6061031
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \- Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia.
- Enrolment
- 136 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 6 Jul 2006 (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.
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Treatment | Experimental | Drug: [S,S]-Reboxetine[S,S]-reboxetine |
| Standard Care | Other | Drug: AnyStandard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy
- Patients at screening must have a score >/=40 mm on the pain visual analogue scale
Key exclusion criteria (2 listed)
- Patients with significant hepatic impairment
- Patients with other severe pain, that may impair the self-assessment of the pain due to DPN
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 |
|---|---|---|
| [S,S]-Reboxetine[S,S]-reboxetine | Drug | Open Treatment |
| AnyAny standard of care treatment for DPN | Drug | Standard Care |
Primary outcome
Vital signs
Time frame: duration of study
Physical examination
Time frame: duration of study
12-lead ECG
Time frame: duration of study
Hematology/Biochemistry
Time frame: duration of study
Adverse events
Time frame: duration of study
8 secondary outcomes
Pain Visual Analogue Scale
Time frame: duration of study
Neuropathic Pain Symptom Inventory
Time frame: duration of study
Modified Brief Pain Inventory-Short Form
Time frame: duration of study
Patient Global Impression of Change
Time frame: duration of study
SF-12 Health Survey
Time frame: duration of study
EQ-5D
Time frame: duration of study
Analgesic Treatment Satisfaction Scale
Time frame: duration of study
Pain-related Medication Utilization
Time frame: duration of study
Results and safety
The study was stopped early (reason given: \- Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
93 sites in 14 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 and Any in people with Pain, run by Pfizer at 93 sites in 14 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 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 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, South Africa, Germany, Canada, India and 9 more countries. 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. 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 due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia.). 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?
Vital signs (time frame: duration of study). The study lists 5 primary outcomes in all. 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 1 Jun 2011.