Diabetic PolyneuropathyPhase 2NCT00878293
Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
A Phase 2 study testing GRT6005 and MS Continus® in people with Diabetic Polyneuropathy, run by Tris Pharma, Inc. at 4 sites in 2 countries.
Trial summary
The purpose of this trial is to determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- GRT6005 and MS Continus®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2009to May 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
- Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.
Who cannot join
- Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
- non Caucasian or Hispanic.
- Concomitant painful disease.
- Life-long history of seizure disorder or epilepsy.
- Subjects with clinical relevant cardiac and vascular diseases.
- Subjects with impaired renal function
- Subjects with impaired hepatic function
- Female subjects who are pregnant or breastfeeding.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Investigator 3
Bad Oeynhausen
Investigator 1
Mainz
Investigator 2
Münster
About this study
Official title: A Randomized Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Pain Due to Diabetic Polyneuropathy
The purpose of this trial is to determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- GRT6005, MS Continus®, Placebo
- Keywords
- analgesic, diabetes mellitus, chronic neuropathic pain, painful polyneuropathy caused by diabetes mellitus type I or II
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT6005Drug
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
MS Continus®Drug
60 mg, capsule, once daily
PlaceboDrug
liquid formulation and capsule, once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Dose 1, 40 µg Receives: Drug: GRT6005 |
| B | Experimental | Dose 2, 120 µg Receives: Drug: GRT6005 |
| C | Experimental | Dose 3 Receives: Drug: GRT6005 |
| D | Experimental | Dose 4 Receives: Drug: GRT6005 |
| E | Experimental | Dose 5 Receives: Drug: GRT6005 |
| F | Experimental | Dose 6 Receives: Drug: GRT6005 |
| G | Experimental | Dose 7 Receives: Drug: GRT6005 |
| H | Active comparator | Morphin Receives: Drug: MS Continus® |
| I | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily pain intensity
Measured: 5 days
Secondary outcomes (1)
Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Forst, Prof. Dr. med, Principal investigator, IKFE, Parcusstr. 8, 55116 Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878293
- Sponsor's protocol ID
- 449723
- Status last verified
- Jul 2021
- First submitted
- 3 Apr 2009
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Pain Due to Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT00878293
- Acronym / sponsor ID
- 449723
- Conditions
- Diabetic Polyneuropathy
- Keywords
- analgesic, diabetes mellitus, chronic neuropathic pain, painful polyneuropathy caused by diabetes mellitus type I or II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Apr 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 trial is to determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GRT6005Dose 1, 40 µg |
| B | Experimental | Drug: GRT6005Dose 2, 120 µg |
| C | Experimental | Drug: GRT6005Dose 3 |
| D | Experimental | Drug: GRT6005Dose 4 |
| E | Experimental | Drug: GRT6005Dose 5 |
| F | Experimental | Drug: GRT6005Dose 6 |
| G | Experimental | Drug: GRT6005Dose 7 |
| H | Active comparator | Drug: MS Continus®Morphin |
| I | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.
Key exclusion criteria (8 listed)
- Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
- non Caucasian or Hispanic.
- Concomitant painful disease.
- Life-long history of seizure disorder or epilepsy.
- Subjects with clinical relevant cardiac and vascular diseases.
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 |
|---|---|---|
| GRT6005liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days | Drug | A, B, C, D, E, F, G |
| MS Continus®60 mg, capsule, once daily | Drug | H |
| Placeboliquid formulation and capsule, once daily | Drug | I |
Primary outcome
Average daily pain intensity
Time frame: 5 days
1 secondary outcome
Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values
Time frame: 5 days
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 15 Jul 2021.
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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.
Thomas Forst, Prof. Dr. med principal investigator
IKFE, Parcusstr. 8, 55116 Mainz
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRT6005 and MS Continus® in people with Diabetic Polyneuropathy, run by Tris Pharma, Inc. at 4 sites in 2 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 1 inclusion and 8 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 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, United Kingdom. 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?
Average daily pain intensity (time frame: 5 days). 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 15 Jul 2021.