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

NCT03783910 | Completed Phase 2 FDA Drug

• 1 other identifier: KF9906/03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Primary Fibromyalgia

Keywords

Chronic pain

Outcome Measures

Primary Outcomes (1)

• Average Pain Intensity over last 3 days of treatment period

  Participants recorded their daily current pain intensity in an electronic diary from the Enrollment Visit until the day of the last visit in the second treatment period using an 11-point Numerical Rating scale (NRS) ranging from 0 = no pain to 10 = pain as bad as you can imagine. Each treatment period lasted for 6 weeks. For the primary endpoint, the average daily current pain intensity over the last 3 days prior to the last visit per treatment period was calculated.

  Last 3 days of treatment period

Secondary Outcomes (19)

• Changes from baseline/period baseline in Average Pain Intensity over last 3 days per treatment period

  At baseline, at period baseline, and for last 3 days of each treatment period

• Average Pain Intensity after initial washout and over Weeks 1 to 6 per treatment period

  Last 3 days of the initial washout period; Week 1, 2, 3, 4, 5 and 6 per treatment period

• Fibromyalgia Impact Questionnaire (FIQ)

  At Enrollment Visit (Visit 1), on Day 1, Day 22, and Day 42 per treatment period, and at Final Visit (14 days after last dose in treatment period 2)

• Tender Point Index (TPI)

  At Enrollment Visit (Visit 1), on Day 1, Day 22, and Day 42 per treatment period, and at Final Visit (14 days after last dose in treatment period 2)

• Average Pain Threshold (APT)

  At Enrollment Visit (Visit 1), on Day 1, Day 22, and Day 42 per treatment period, and at Final Visit (14 days after last dose in treatment period 2)

Study Arms (2)

GRT9906

EXPERIMENTAL

Participants received 80-240 mg of GRT9906 oral for up to 6 weeks (1 week of titration, 5 weeks of maintenance treatment). Participants started with 40 mg of GRT9906 on the first and 80 mg (40 mg twice daily) on the second day. They could increase the dose every day by 1 tablet (i.e., GRT9906 40 mg), up to a maximum daily dose of 240 mg (120 mg twice daily). Participants experiencing adverse events could reduce the dose to the next lower, better tolerated daily dose (but not lower than 80 mg \[40 mg twice daily\]). By Day 8, every participant had reached their optimal daily dose and was asked to continue on the identified dosing regimen for the following 5 weeks.

Drug: GRT9906

Placebo

PLACEBO COMPARATOR

Participants received Placebo (2-6 tablets daily) oral for up to 6 weeks.

Drug: Placebo

Interventions

GRT9906 DRUG

One prolonged-release tablet containing 40 mg of GRT9906

GRT9906

Placebo DRUG

Placebo matching GRT9906 tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 might affect drug absorption, metabolism or excretion.
• Nursing mother.
• Causes of chronic pain other than FMS and mild osteoarthritis of the hand.
• Proven rheumatoid disease with positive rheumatoid factor or antinuclear antibody (ANA) at screening.
• History of marked repolarization abnormality (e.g., suspicion of or definite congenital long QT syndrome).
• QT values of: corrected QT Bazett (QTcB) females equal to or above 450 milliseconds (ms), QTcB males equal to or above 430 ms, uncorrected QT equal to or above 500 ms at Enrollment Visit.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (6)

006 Research Facility

DeLand, Florida, 32720, United States

Location

005 Research Facility

Charlotte, North Carolina, 28210, United States

Location

004 Research Facility

Medford, Oregon, 97504, United States

Location

002 Research Facility

Portland, Oregon, 97239, United States

Location

001 Research Facility

San Antonio, Texas, 78213, United States

Location

003 Research Facility

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973 Aug;60(8):646-9. doi: 10.1002/bjs.1800600817. No abstract available.

  PMID: 4541913 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

3-(2-dimethylaminomethylcyclohexyl)phenol

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Grünenthal Study Director

  Grünenthal GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This dose-titration study was conducted with randomized, multi-center, double-blind, placebo-controlled, crossover design and multiple administrations in 2 treatment sequences in treatment periods 1 and 2: Sequence GRT9906-Placebo and sequence Placebo-GRT9906.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 21, 2018
• Study Start: September 19, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 20, 2006
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)