Painful Diabetic NeuropathyPhase 2NCT00837941
A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)
A Phase 2 study testing Comparator: A: Pregabalin, Comparator: B: Duloxetine and Comparator: C: Diphenhydramine hydrochloride in people with Painful Diabetic Neuropathy, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- Comparator: A: Pregabalin, Comparator: B: Duloxetine and Comparator: C: Diphenhydramine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Sep 2009
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin
- Patient has pain in both feet that occurred after onset of diabetes
- Patient agrees to maintain a consistent activity level throughout the study
- Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy
- Female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study
- Patients taking a pain medication must be on a stable dose at least 1 month prior to participating in study
Who cannot join
- Patient has a history of congestive heart failure
- Patient has/had a seizure disorder
- Patient has tried and failed 3 or more drugs to treat neuropathic pain
- Patient is currently taking pregabalin or duloxetine hydrochloride
- Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma)
- Patient has history of hepatitis B or C or HIV infection
- Patient has skin-condition that may decrease sensitivity in area of neuropathic pain
About this study
Official title: Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy
The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Comparator: A: Pregabalin, Comparator: B: Duloxetine, Comparator: C: Diphenhydramine hydrochloride
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: A: PregabalinDrug
1 Pregabalin 300 mg capsule
Comparator: B: DuloxetineDrug
1 Duloxetine hydrochloride 60 mg capsule
Comparator: C: Diphenhydramine hydrochlorideDrug
1 Diphenhydramine hydrochloride 25mg capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | sequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride Receives: Drug: Comparator: A: Pregabalin; Drug: Comparator: B: Duloxetine; Drug: Comparator: C: Diphenhydramine hydrochloride |
| 2 | Experimental | sequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride Receives: Drug: Comparator: A: Pregabalin; Drug: Comparator: B: Duloxetine; Drug: Comparator: C: Diphenhydramine hydrochloride |
| 3 | Experimental | sequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin Receives: Drug: Comparator: A: Pregabalin; Drug: Comparator: B: Duloxetine; Drug: Comparator: C: Diphenhydramine hydrochloride |
| 4 | Experimental | sequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride Receives: Drug: Comparator: A: Pregabalin; Drug: Comparator: B: Duloxetine; Drug: Comparator: C: Diphenhydramine hydrochloride |
| 5 | Experimental | sequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin Receives: Drug: Comparator: A: Pregabalin; Drug: Comparator: B: Duloxetine; Drug: Comparator: C: Diphenhydramine hydrochloride |
| 6 | Experimental | sequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride Receives: Drug: Comparator: A: Pregabalin; Drug: Comparator: B: Duloxetine; Drug: Comparator: C: Diphenhydramine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic efficacy measured by patients self reported pain level after single dose administration
Measured: 5-11 hours after single dose is administered
Secondary outcomes (1)
The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo
Measured: 24 hours after single dose is administered
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 startApr 2009
- Primary completionAug 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837941
- Sponsor's protocol ID
- 0000-115
- Other IDs
- 2009_515
- Status last verified
- Jul 2015
- First submitted
- 5 Feb 2009
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00837941
- Acronym / sponsor ID
- 0000-115
- Conditions
- Painful Diabetic Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- 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.
The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Comparator: A: Pregabalin, Drug: Comparator: B: Duloxetine, Drug: Comparator: C: Diphenhydramine hydrochloridesequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride |
| 2 | Experimental | Drug: Comparator: A: Pregabalin, Drug: Comparator: B: Duloxetine, Drug: Comparator: C: Diphenhydramine hydrochloridesequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride |
| 3 | Experimental | Drug: Comparator: A: Pregabalin, Drug: Comparator: B: Duloxetine, Drug: Comparator: C: Diphenhydramine hydrochloridesequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin |
| 4 | Experimental | Drug: Comparator: A: Pregabalin, Drug: Comparator: B: Duloxetine, Drug: Comparator: C: Diphenhydramine hydrochloridesequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride |
| 5 | Experimental | Drug: Comparator: A: Pregabalin, Drug: Comparator: B: Duloxetine, Drug: Comparator: C: Diphenhydramine hydrochloridesequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin |
| 6 | Experimental | Drug: Comparator: A: Pregabalin, Drug: Comparator: B: Duloxetine, Drug: Comparator: C: Diphenhydramine hydrochloridesequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin
- Patient has pain in both feet that occurred after onset of diabetes
- Patient agrees to maintain a consistent activity level throughout the study
- Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy
- Female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study
Key exclusion criteria (7 listed)
- Patient has a history of congestive heart failure
- Patient has/had a seizure disorder
- Patient has tried and failed 3 or more drugs to treat neuropathic pain
- Patient is currently taking pregabalin or duloxetine hydrochloride
- Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma)
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 |
|---|---|---|
| Comparator: A: Pregabalin1 Pregabalin 300 mg capsule | Drug | 1, 2, 3, 4, 5, 6 |
| Comparator: B: Duloxetine1 Duloxetine hydrochloride 60 mg capsule | Drug | 1, 2, 3, 4, 5, 6 |
| Comparator: C: Diphenhydramine hydrochloride1 Diphenhydramine hydrochloride 25mg capsule | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
analgesic efficacy measured by patients self reported pain level after single dose administration
Time frame: 5-11 hours after single dose is administered
1 secondary outcome
The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo
Time frame: 24 hours after single dose is administered
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
Related trials for Painful Diabetic Neuropathy
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Painful Diabetic Peripheral Neuropathy, Diabetes Complication
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Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
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Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
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SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
Painful Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain (DPN)
Recruiting
Neurofeedback for the Management of Neuropathic Pain in People With Diabetes
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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
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comparator: A: Pregabalin, Comparator: B: Duloxetine and Comparator: C: Diphenhydramine hydrochloride in people with Painful Diabetic Neuropathy, run by Merck Sharp & Dohme LLC.
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 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: withdrawn, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
analgesic efficacy measured by patients self reported pain level after single dose administration (time frame: 5-11 hours after single dose is administered). 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 27 Jul 2015.