Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
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|ClinicalTrials.gov Identifier: NCT01347671|
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : July 15, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Pain Diabetic Neuropathies||Drug: GRT6005 Drug: Matching Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Active Comparator: 25 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day
25µg/day once daily
Active Comparator: 75 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day
75 µg/day once daily
Active Comparator: 200 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day
200 µg/day once daily
Placebo Comparator: Matching Placebo
Participants allocated to this treatment arm will receive a dose of matched placebo once a day.
Drug: Matching Placebo
- 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".
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347671
|Principal Investigator:||Thomas Forst, Prof. Dr.||ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany|
|Responsible Party:||Tris Pharma, Inc.|
|Other Study ID Numbers:||
2010-022557-42 ( EudraCT Number )
|First Posted:||May 4, 2011 Key Record Dates|
|Last Update Posted:||July 15, 2021|
|Last Verified:||July 2021|
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