PainPhase 2NCT01347671
Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
A Phase 2 study testing GRT6005 in people with Pain and Diabetic Neuropathies, run by Tris Pharma, Inc. at 22 sites in 3 countries.
Trial summary
The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Diabetic Neuropathies
- What is being tested?
- GRT6005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 22 sitesin 3 countries
- Study dates
- May 2011to Jan 2012
- 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
- Men and women, 18 to 75 years old.
- Type 1 or type 2 diabetes.
- Painful DPN symptoms and signs for at least 3 months.
- Blood glucose controlled with medication.
- Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent.
- Prior analgesic medication.
- Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization.
Who cannot join
- Impaired liver, cardiac or renal function.
- Breastfeeding and pregnancy.
- History of substance abuse, alcohol or medication.
- Chronic gastrointestinal disease.
- History of seizures and or epilepsy.
- History or presence of malignancy.
- Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
- Allergies to opioids, acetaminophen or excipients of the medications.
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
Germany16 sites
Site 4112
Aschaffenburg, 63739
Site 4109
Bad Oeynhausen, 32545
Site 4101
Berlin, 10117
Site 4110
Berlin, 13125
Site 4111
Dresden, 01307
Site 4107
Hamburg, 20253
Site 4117
Hamburg, 22587
Site 4108
Hanover, 30159
Site 4104
Hanover, 30167
Site 4115
Heidelberg, 69120
Site 4106
Kiel, 24119
Site 4102
Lübeck, 23562
Site 4103
Mainz, 55116
Site 4105
Münster, 48145
Site 4113
Schwerin, 19055
Site 4116
Wangen, 88239
Romania5 sites
Site 4405
Bucharest, 010496
Site 4402
Bucharest, 011025
Site 4407
Sibiu, 550166
Site 4401
Târgu Mureş, 540139
Site 4406
Timișoara, 300594
About this study
Official title: A Randomized 4-week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Pain Due to Diabetic Polyneuropathy.
The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.
- Conditions
- Pain, Diabetic Neuropathies
- Being tested
- GRT6005, Matching Placebo
- Keywords
- analgesia, analgesics, pain, chronic pain, neuropathic pain
- Medical subject headings
- Pain, Diabetic Neuropathies, Agnosia, Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT6005Drug
25µg/day once daily
GRT6005Drug
75 µg/day once daily
GRT6005Drug
200 µg/day once daily
Matching PlaceboDrug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| 25 µg GRT6005 | Active comparator | Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day Receives: Drug: GRT6005 |
| 75 µg GRT6005 | Active comparator | Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day Receives: Drug: GRT6005 |
| 200 µg GRT6005 | Active comparator | Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day Receives: Drug: GRT6005 |
| Matching Placebo | Placebo comparator | Participants allocated to this treatment arm will receive a dose of matched placebo once a day. Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean daily pain intensity score
Participants will be selected based on their medical history and clinical examination.
Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents "pain as bad as you can imagine".
Measured: Baseline to Week 4
Secondary outcomes (11)
Response measured in percentage change of pain intensity from baseline
Measured: End of 4 Weeks
Changes in Quantitative Sensory Testing from baseline
Measured: Baseline, week 1 and week 4
Neuropathic Pain Scale, changes from baseline
Measured: End of 4 weeks
Short Form of the Brief Pain Inventory, changes from baseline
Measured: End of 4 weeks
Leeds Sleep Evaluation Questionnaire
Measured: End of treatment
Quality of Life Index -Short-Form-12®, from baseline
Measured: End of treatment
Patient's Global Impression of Change
Measured: End of treatment
Quality of Life EuroQoL-5 Dimension score, change from baseline
Measured: End of 4 weeks
Rescue medication use
Measured: End of 4 weeks
Clinical Opioid Withdrawal Scale
Measured: End of 4 weeks
Plasma concentration
Measured: End of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2012
- Study completionJan 2012
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.
- 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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Thomas Forst, Prof. Dr., Principal investigator, ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347671
- Sponsor's protocol ID
- 430409
- Other IDs
- 2010-022557-42
- Status last verified
- Jul 2021
- First submitted
- 2 May 2011
- 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 4-week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Pain Due to Diabetic Polyneuropathy.
- ClinicalTrials.gov ID
- NCT01347671
- Acronym / sponsor ID
- 430409
- Conditions
- Pain, Diabetic Neuropathies
- Keywords
- analgesia, analgesics, pain, chronic pain, neuropathic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- May 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 May 2011 (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 investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 25 µg GRT6005 | Active comparator | Drug: GRT6005Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day |
| 75 µg GRT6005 | Active comparator | Drug: GRT6005Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day |
| 200 µg GRT6005 | Active comparator | Drug: GRT6005Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day |
| Matching Placebo | Placebo comparator | Drug: Matching PlaceboParticipants allocated to this treatment arm will receive a dose of matched placebo once a day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women, 18 to 75 years old.
- Type 1 or type 2 diabetes.
- Painful DPN symptoms and signs for at least 3 months.
- Blood glucose controlled with medication.
- Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent.
Key exclusion criteria (8 listed)
- Impaired liver, cardiac or renal function.
- Breastfeeding and pregnancy.
- History of substance abuse, alcohol or medication.
- Chronic gastrointestinal disease.
- History of seizures and or epilepsy.
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 |
|---|---|---|
| GRT600525µg/day once daily | Drug | 25 µg GRT6005 |
| GRT600575 µg/day once daily | Drug | 75 µg GRT6005 |
| GRT6005200 µg/day once daily | Drug | 200 µg GRT6005 |
| Matching PlaceboOnce daily | Drug | Matching Placebo |
Primary outcome
Change in mean daily pain intensity score
Time frame: Baseline to Week 4
Participants will be selected based on their medical history and clinical examination. Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents "pain as bad as you can imagine".
11 secondary outcomes
Response measured in percentage change of pain intensity from baseline
Time frame: End of 4 Weeks
Changes in Quantitative Sensory Testing from baseline
Time frame: Baseline, week 1 and week 4
Neuropathic Pain Scale, changes from baseline
Time frame: End of 4 weeks
Short Form of the Brief Pain Inventory, changes from baseline
Time frame: End of 4 weeks
Leeds Sleep Evaluation Questionnaire
Time frame: End of treatment
Quality of Life Index -Short-Form-12®, from baseline
Time frame: End of treatment
Patient's Global Impression of Change
Time frame: End of treatment
Quality of Life EuroQoL-5 Dimension score, change from baseline
Time frame: End of 4 weeks
Rescue medication use
Time frame: End of 4 weeks
Clinical Opioid Withdrawal Scale
Time frame: End of 4 weeks
Plasma concentration
Time frame: End of 4 weeks
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. principal investigator
ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRT6005 in people with Pain and Diabetic Neuropathies, run by Tris Pharma, Inc. at 22 sites in 3 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 7 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 22 sites in Germany, Romania, Bulgaria. 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 intensity score (time frame: Baseline to Week 4). 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.