Phase II Study of CG100649 for Primary Osteoarthritis in Male Subjects

NCT00530452 | Unknown Phase 2

• 2 other identifiers: CG100649-2-01EudraCT number: 2007-001197-93
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the safety and efficacy of 3 loading and maintenance dose levels of CG100649 administered for 21 days in the treatment of osteoarthritis pain.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

COX-2; carbonic anhydrase; osteoarthritis; anti-inflammatory; Cyclooxygenase Inhibitors

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be the change in the sum of the WOMAC OA index at Day 21 vs. Baseline (Day 0). The primary analysis will be via repeated measures using mixed effects ANOVA with baseline and subject as random variables.

  21 days

Secondary Outcomes (1)

• Change in av. Daily Pain Intensity (DPI) during last 7 days & entire 21 days); • Change in worst DPI (last 7 days; entire 21 days); • Change in WOMAC OA index on Days 7, 14, 28, and 35 vs. baseline; • Subject's Global Assessment • Safety

  35 days

Study Arms (4)

A

EXPERIMENTAL

2.0 mg (loading dose, Day 0) followed by 0.3 mg/day (Days 1-20)

Drug: CG100649

B

EXPERIMENTAL

4.0 mg (loading dose, Day 0) followed by 0.6 mg/day (Days 1-20)

Drug: CG100649

C

EXPERIMENTAL

8.0 mg (loading dose, Day 0) followed by 1.2 mg/day (Days 1-20)

Drug: CG100649

D

PLACEBO COMPARATOR

Placebo (identical number of capsules to active drug groups) (Days 0-20)

Drug: Silicified microcrystalline cellulose + talc

Interventions

CG100649 DRUG

Dual-acting COX-2 inhibitor \& carbonic anhydrase inhibitor in gelatin capsules. Oral loading doses (2, 4, or 8 mg vs. placebo) followed by daily oral maintenance doses (0.3, 0.6, or 1.2 mg vs. placebo) for 20 days (total 21 days therapy).

A; B; C

Silicified microcrystalline cellulose + talc DRUG

Gelatin capsules containing cellulose/talc matched for weight and color to experimental medication. Placebo administered orally 1x/day.

D

Eligibility Criteria

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

You may qualify if:

• Males, age 18-75 years old;
• BMI 19-35 kg/m2;
• Good health;
• Systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, resting HR 45-90 bpm without medication;
• Clinical chemistry profile within 2x normal range without medication;
• Urinalysis including urinary creatinine within 2x normal limits;
• OA confirmed by radiographs obtained within the past 20 years and diagnosed according to ACR guidelines; subjects must qualify as ACR global functional status I, II, or III (excluding IV) and Kellgren-Lawrence grade 1, 2 or 3 (excluding grades 0 and 4);
• Subjects must have had chronic pain for ≥3 months from OA;
• Subjects must have been receiving stable oral doses of NSAIDs or COX-2 inhibitors at least 3 days per week for one month or longer;
• Subjects may take paracetamol ≤2g/day) for breakthrough pain;
• During the washout period, the average daily pain intensity (DPI) score must be between 4 and 8 on a 0-10 numerical rating scale for at least 3 days, and no greater than 9 for more than 1 day, in the last 5 days prior to randomization per Baseline pain diary;
• Subjects must be able to read, understand and follow the study instructions;
• Subjects and their sexual partners must agree to use double barrier contraception during the study period and for 2 months afterward.

You may not qualify if:

• Use of any analgesics except the study medication or paracetamol;
• Presence or history of peripheral edema within the past 5 years;
• History of congestive heart failure;
• Use of chemotherapy agents or history of cancer within five years prior to the screening visit;
• History of bacterial or viral infection requiring treatment with antibiotics, antivirals, or anti-retrovirals within 3 months of study;
• Use of drugs which are P450 3A4 inducers or inhibitors within the past 30 days;
• Use of prescribed systemic or topical medications or any dietary aids or foods that are known to modulate drug metabolizing enzymes within 14 days of dose administration;
• Difficulty in swallowing oral medications;
• Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease;
• Subjects requiring knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study;
• Subjects who have had surgery on the affected joint within one year prior to the study and subjects with a prosthesis at the index joint;
• Use of systemic corticosteroids within 2 months of screening, or intra-articular viscosupplementation within the past 6 months;
• History of seizure disorder;
• Use of antidepressants or anticonvulsants for any reason including for chronic pain within 2 months of screening;
• Serious psychosocial co-morbidities;

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Orthopaedische Praxis

Bad Dürrheim, Baden-Wurttemberg, BW 78073, Germany

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis

Interventions

CG100649; Talc

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Magnesium Silicates; Magnesium Compounds; Inorganic Chemicals; Silicates; Minerals; Silicic Acid; Silicon Dioxide; Silicon Compounds

Study Officials

• William K Schmidt, PhD

  CrystalGenomics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Stefania Di Credico

CONTACT

+39 02 95794.1; stefania.decredico@quintiles.com

Bernard Chung

CONTACT

510-594-8200; bernard@cgpharma.com

Study Design

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

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 13, 2008

Record last verified: 2008-06

Locations

DE (1)