Diabetic Peripheral Neuropathic PainPhase 2NCT00838799
Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
A Phase 2 study testing RGH-896 and pregabalin in people with Diabetic Peripheral Neuropathic Pain, run by Forest Laboratories at 54 sites in United States.
Trial summary
This study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- RGH-896 and pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 458 participants
- Where
- 54 sitesUnited States
- Study dates
- Feb 2009to Apr 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients 18 to 75 years of age
- A diagnosis of painful diabetic neuropathy
- Controlled blood glucose
- Willingness to wash out all analgesic medications used for DPNP
- Female patients either postmenopausal, surgically sterile, or practicing a medically acceptable method of contraception
- Female patients who are not pregnant
Who cannot join
- Acute infections or cardiac problems
- Past use of pregabalin
- History of severe psychiatric disorder
- History of any amputation due to diabetes
- History of seizure disorder
- Active diabetic foot ulcers
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
Forest Investigative Site
Albuquerque, New Mexico, 87108
Forest Investigative Site
Anaheim, California, 92801
Forest Investigative Site
Birmingham, Alabama, 35242
Forest Investigative Site
Boise, Idaho, 83642
Forest Investigative Site
Boulder, Colorado, 80304
Forest Investigative Site
Bradenton, Florida, 34203
Forest Investigative Site
Brandon, Florida, 33511
Forest Investigative Site
Burbank, California, 91505
Forest Investigative Site
Charlotte, North Carolina, 28211
Forest Investigative Site
Cleveland, Ohio, 44122
Forest Investigative Site
Columbia, South Carolina, 29201
Forest Investigative Site
Covington, Louisiana, 70433
Forest Investigative Site
Dallas, Texas, 75246
Forest Investigative Site
DeLand, Florida, 32720
Forest Investigative Site
Duncansville, Pennsylvania, 16635
Forest Investigative Site
Greenville, North Carolina, 27834
Forest Investigative Site
Hollywood, Florida, 33023
Forest Investigative Site
Honolulu, Hawaii, 96814
Forest Investigative Site
Jacksonville, Florida, 32216
Forest Investigative Site
Jonesboro, Arkansas, 72401
Forest Investigative Site
Kettering, Ohio, 45429
Forest Investigative Site
Lake Jackson, Texas, 77566
Forest Investigative Site
Lakewood, California, 90712
Forest Investigative Site
Little Rock, Arkansas, 72205
Forest Investigative Site
Memphis, Tennessee, 38119
Forest Investigative Site
Mesa, Arizona, 85210
Forest Investigative Site
Miami, Florida, 33108
Forest Investigative Site
National City, California, 91950
Forest Investigative Site
New Britain, Connecticut, 06050
Forest Investigative Site
New York, New York, 10004
Forest Investigative Site
North Little Rock, Arkansas, 72114
Forest Investigative Site
Orlando, Florida, 32806
Forest Investigative Site
Owings Mills, Maryland, 21117
Forest Investigative Site
Pembroke Pines, Florida, 33024
Forest Investigative Site
Philadelphia, Pennsylvania, 19139
Forest Investigative Site
Riverside, California, 92506
Forest Investigative Site
Sacramento, California, 95821
Forest Investigative Site
Salt Lake City, Utah, 84106
Forest Investigative Site
San Antonio, Texas, 78229
Forest Investigative Site
San Diego, California, 92117
Forest Investigative Site
Santa Monica, California, 90404
Forest Investigative Site
St Louis, Missouri, 63141
Forest Investigative Site
Tacoma, Washington, 98405
Forest Investigative Site
Tampa, Florida, 33606
Forest Investigative Site
Tempe, Arizona, 85282
Forest Investigative Site
Tulsa, Oklahoma, 74104
Forest Investigative Site
Tustin, California, 92780
Forest Investigative Site
Virginia Beach, Virginia, 23454
Forest Investigative Site
Walnut Creek, California, 94598
Forest Investigative Site
West Caldwell, New Jersey, 07006
Forest Investigative Site
West Palm Beach, Florida, 33401
Forest Investigative Site
Westlake Village, California, 91361
Forest Investigative Site
Wichita, Kansas, 67203
Forest Investigative Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
This study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- RGH-896, pregabalin, placebo
- Keywords
- diabetic, peripheral, neuropathic, pain, chronic, diabetes
- Medical subject headings
- Pain, Bronchiolitis Obliterans Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGH-896Drug
45 mg TID, capsules, 14 weeks.
RGH-896Drug
30 mg TID, capsules, 14 weeks.
RGH-896Drug
15 mg TID, capsules, 14 weeks.
pregabalinDrug
Also called Lyrica
100 mg, TID, capsules, 14 weeks.
placeboDrug
TID, capsules, 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RGH-896 |
| 2 | Experimental | Not described Receives: Drug: RGH-896 |
| 3 | Experimental | Not described Receives: Drug: RGH-896 |
| 4 | Active comparator | Not described Receives: Drug: pregabalin |
| 5 | 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 daily pain rating
Measured: Baseline to Week 14
Secondary outcomes (1)
50% reduction in pain
Measured: Baseline to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Ltd.
- Investigators
- Allyson Gage, PhD, Study director, Forest Research Institute, a subsidiary of Forest Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838799
- Sponsor's protocol ID
- RG8-MD-02
- Status last verified
- Jul 2011
- First submitted
- 5 Feb 2009
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00838799
- Acronym / sponsor ID
- RG8-MD-02
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Keywords
- diabetic, peripheral, neuropathic, pain, chronic, diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Ltd.
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (actual)
- First posted
- 6 Feb 2009 (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 study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RGH-896 |
| 2 | Experimental | Drug: RGH-896 |
| 3 | Experimental | Drug: RGH-896 |
| 4 | Active comparator | Drug: pregabalin |
| 5 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female outpatients 18 to 75 years of age
- A diagnosis of painful diabetic neuropathy
- Controlled blood glucose
- Willingness to wash out all analgesic medications used for DPNP
- Female patients either postmenopausal, surgically sterile, or practicing a medically acceptable method of contraception
Key exclusion criteria (6 listed)
- Acute infections or cardiac problems
- Past use of pregabalin
- History of severe psychiatric disorder
- History of any amputation due to diabetes
- History of seizure disorder
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 |
|---|---|---|
| RGH-89645 mg TID, capsules, 14 weeks. | Drug | 1 |
| RGH-89630 mg TID, capsules, 14 weeks. | Drug | 2 |
| RGH-89615 mg TID, capsules, 14 weeks. | Drug | 3 |
| pregabalinAlso: Lyrica100 mg, TID, capsules, 14 weeks. | Drug | 4 |
| placeboTID, capsules, 14 weeks. | Drug | 5 |
Primary outcome
Change in mean daily pain rating
Time frame: Baseline to Week 14
1 secondary outcome
50% reduction in pain
Time frame: Baseline to Week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
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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.
Allyson Gage, PhD study director
Forest Research Institute, a subsidiary of Forest Laboratories Inc.
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RGH-896 and pregabalin in people with Diabetic Peripheral Neuropathic Pain, run by Forest Laboratories at 54 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 daily pain rating (time frame: Baseline to Week 14). 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 14 Jul 2011.