Diabetic Neuropathy, PainfulPhase 2NCT00381719
Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy
A Phase 2 study testing AGN 203818 in people with Diabetic Neuropathy, Painful, run by Allergan at 1 site in United States.
Trial summary
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating pain in patients with painful diabetic peripheral neuropathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- AGN 203818
- 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
- 1 siteUnited States
- Study dates
- Oct 2006to Nov 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 diabetic peripheral neuropathy
- Moderate to severe neuropathic pain
Who cannot join
- Any other uncontrolled disease
- Pregnant or nursing females
Trial locations and contacts
1 site in 1 country.
About this study
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating pain in patients with painful diabetic peripheral neuropathy
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- AGN 203818, placebo capsule
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN 203818Drug
3 mg Capsule twice daily for 4 weeks
AGN 203818Drug
20 mg Capsule twice daily for 4 weeks
AGN 203818Drug
60 mg Capsule twice daily for 4 weeks
placebo capsuleDrug
Capsule twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3 mg Receives: Drug: AGN 203818 |
| 2 | Experimental | 20 mg Receives: Drug: AGN 203818 |
| 3 | Experimental | 60 mg Receives: Drug: AGN 203818 |
| 4 | Placebo comparator | Placebo Receives: Drug: placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Daily Pain Score
Measured: 1 Month
Secondary outcomes (3)
Changes in sleep interference score
Measured: Week 4
Beck depression inventory
Measured: Week 4
Quality of Life questionnaires
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy, PainfulStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381719
- Sponsor's protocol ID
- 203818-004
- Status last verified
- Dec 2007
- First submitted
- 26 Sep 2006
- Last updated
- 7 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00381719
- Acronym / sponsor ID
- 203818-004
- Conditions
- Diabetic Neuropathy, Painful
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Sep 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.
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating pain in patients with painful diabetic peripheral neuropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AGN 2038183 mg |
| 2 | Experimental | Drug: AGN 20381820 mg |
| 3 | Experimental | Drug: AGN 20381860 mg |
| 4 | Placebo comparator | Drug: placebo capsulePlacebo |
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 diabetic peripheral neuropathy
- Moderate to severe neuropathic pain
Key exclusion criteria (2 listed)
- Any other uncontrolled disease
- Pregnant or nursing females
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 |
|---|---|---|
| AGN 2038183 mg Capsule twice daily for 4 weeks | Drug | 1 |
| AGN 20381820 mg Capsule twice daily for 4 weeks | Drug | 2 |
| AGN 20381860 mg Capsule twice daily for 4 weeks | Drug | 3 |
| placebo capsuleCapsule twice daily for 4 weeks | Drug | 4 |
Primary outcome
Reduction in Daily Pain Score
Time frame: 1 Month
3 secondary outcomes
Changes in sleep interference score
Time frame: Week 4
Beck depression inventory
Time frame: Week 4
Quality of Life questionnaires
Time frame: Week 4
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 7 Jan 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGN 203818 in people with Diabetic Neuropathy, Painful, run by Allergan at 1 site 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: finished, as of the sponsor's last update on 7 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Reduction in Daily Pain Score (time frame: 1 Month). 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 7 Jan 2008.