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Efficacy and Safety of GRT9906 Tablets Compared to Placebo in Patients With Fibromyalgia

CompletedPhase 2NCT03783910
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The study was performed in participants suffering from fibromyalgia and investigated efficacy after treatment with several doses of GRT9906 versus placebo. Furthermore, it was to be found out if treatment with GRT9906 was safe and well-tolerated.

Study details

Official title
Cross-over Multiple Dose Study Assessing the Analgesic Efficacy and Safety of Oral GRT9906 Compared to Placebo in Subjects With Primary Fibromyalgia Syndrome
Conditions
  • Primary Fibromyalgia
Interventions
Sponsor
Grünenthal GmbH
Start date
2005-09-19
Primary completion
2006-10
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
6

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male or female ambulatory participants of any ethnic group, aged 18 to 75 years inclusive at enrollment. * Primary fibromyalgia syndrome (FMS) diagnosed according to the American College of Rheumatology (ACR) 1990 criteria, persistent for at least 6 months. * Average Pain Intensity of FMS pain over the last 3 days before randomization visit must be at least 4 points, using 11-point numerical rating scale (NRS). * Negative urine test for drugs of abuse at the Day 1 visit of each treatment period. * Women of childbearing potential must use an acceptable method of contraception (i.e., double barrier, hormonal or intra-uterine device method) during the study period and have a negative urine pregnancy test at the Enrollment Visit and at the Day 1 visit of each treatment period. * Compliance with use and completion of assessments by means of electronic diaries; 80 percent of entries must be available for the week before randomization. * Written informed consent for study participation given. Exclusion Criteria: * Participation in another study of IMPs or devices parallel to, or less than 1 month prior to enrollment, or previous participation in this study. * Known to or suspected of not being able to comply with the study protocol and the use of the IMPs. * Not able to communicate meaningfully with the Investigator and staff. * Evidence or history of alcohol, medication or drug dependency during the past 12 months. History of opiate dependency at any point in life. * Evidence or history of neurotic personality, psychiatric illness including anxiety disorder, severe senile dementia, Alzheimer's disease, history of seizures or pre-existing conditions that lower seizure threshold (e.g., head trauma), or suicide risk. * Current depression needing treatment with antidepressants. * Currently or previously diagnosed with malignancies except basal cell carcinoma; poor medical status (e.g., New York Heart Association \[NYHA\] class equal to or above 3; Child classification for hepatic impairment above A \[Pugh et al. 1973\]; decompensated chronic obstructive pulmonary disease) or, at the discretion of the Investigator, clinical signs that raise concerns about participant's suitability for the study. * Creatinine higher than 1.5-times of upper limit of normal (ULN) range. * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) higher than twice the ULN range. * Any chronic disease (e.g., hepatic, renal and/or gastrointestinal) that m…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03783910