lansoprazole and Arthritis studies

Lansoprazole: A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.

Research Excerpts

Excerpt	Relevance	Reference
"Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain."	9.16	Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial. ( Asaka, M; Ashida, K; Hiraishi, H; Hiramatsu, N; Kanto, T; Katsuo, S; Kontani, T; Matsui, S; Mizokami, Y; Sakaki, N; Soen, S; Sugano, K; Takei, Y; Takeuchi, T, 2012)
"Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain."	5.16	Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial. ( Asaka, M; Ashida, K; Hiraishi, H; Hiramatsu, N; Kanto, T; Katsuo, S; Kontani, T; Matsui, S; Mizokami, Y; Sakaki, N; Soen, S; Sugano, K; Takei, Y; Takeuchi, T, 2012)
"A combination package containing delayed-release capsules of the proton pump inhibitor lansoprazole (15 mg once daily) and tablets of the NSAID naproxen (375 or 500 mg twice daily) has been approved for reducing the risk of NSAID-associated gastric ulcers in NSAID-requiring patients with a documented history of gastric ulcer."	4.82	Delayed-release lansoprazole plus naproxen. ( Curran, MP; Wellington, K, 2004)

Research

Studies (3)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Hamilton Depression Rating Scale (HAM-D-24)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	2 (66.67)	29.6817
2010's	1 (33.33)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Sugano, K	1
Kontani, T	1
Katsuo, S	1
Takei, Y	1
Sakaki, N	1
Ashida, K	1
Mizokami, Y	1
Asaka, M	1
Matsui, S	1
Kanto, T	1
Soen, S	1
Takeuchi, T	1
Hiraishi, H	1
Hiramatsu, N	1
Curran, MP	1
Wellington, K	1
Spiegel, BM	1
Chiou, CF	1
Ofman, JJ	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis[NCT05005910]	Early Phase 1	194 participants (Actual)	Interventional	2021-09-01	Completed
Double-blind, Placebo-controlled Study of the Safety and Efficacy of Eszopiclone in the Treatment of Insomnia in Patients With Chronic Low Back Pain[NCT00365976]	Phase 4	58 participants (Actual)	Interventional	2006-08-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. (NCT00365976)
Timeframe: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4

Insomnia Severity Index (ISI)

Intervention	units on a scale (Mean)
	prenaprosyn Baseline	postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	6.45	6.38	4.54	4.14	2.62
Placebo	7.10	6.57	5.53	5.07	6.21

The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0-28: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). (NCT00365976)
Timeframe: Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4

Mean Sleep Onset Latency (SOL)

Mean Subjective Sleep Diary Derived Total Sleep Time (TST)

Intervention	units on a scale (Mean)
	Prenaprosyn Baseline	Postnaprosyn baseline	Week 1	Week 2	Week 4
Eszopiclone	18.85	18.00	11.28	10.61	8.38
Placebo	20.26	16.78	12.85	12.74	13.75

Intervention	minutes (Mean)
	Postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	38.28	22.36	17.50	15.28
Placebo	34.11	27.00	23.10	19.91

Nightly total sleep time was averaged from diary entries. (NCT00365976)
Timeframe: Postnaprosyn baseline, Week 1, week 2, week 4

Number of Awakenings

Patient Global Impression of Pain Ratings

Intervention	Minutes (Mean)
	postnaprosyn baseline	week 1	week 2	Week 4
Eszopiclone	316.96	403.47	421.97	411.97
Placebo	380.45	375.56	382.11	388.96

Intervention	awakenings (Mean)
	Postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	2.29	1.31	1.35	1.33
Placebo	2.08	1.98	2.13	2.34

Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain) (NCT00365976)
Timeframe: postnaprosyn Baseline, Week 1, Week 2 week 4

Roland Morris Low Back Pain Inventory (RMLBPI)

Intervention	units on a scale (Mean)
	postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	4.02	3.54	3.30	3.08
Placebo	3.90	3.82	4.01	3.80

"The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 yes-no items assessing potential disabilities.~Scores range from 0 (no disability) to 24 (severe disability)." (NCT00365976)
Timeframe: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4

Sleep Quality Ratings

Intervention	units on a scale (Mean)
	prenaprosyn Baseline	postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	12.27	9.97	9.10	7.63	6.59
Placebo	11.33	10.30	9.05	9.32	7.94

Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep (NCT00365976)
Timeframe: Postnaprosyn Baseline, Week 1, Week 2 week 4

Visual Analog Scale Pain Ratings (VAS)

Intervention	units on a scale (Mean)
	Postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	4.52	5.99	6.18	6.38
Placebo	4.44	4.90	5.33	5.29

Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain (NCT00365976)
Timeframe: Postnaprosyn baseline, Week 1, Week 2, Week 4

Article	Year
Delayed-release lansoprazole plus naproxen. Drugs, 2004, Volume: 64, Issue:17 Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents;	2004
Minimizing complications from nonsteroidal antiinflammatory drugs: cost-effectiveness of competing strategies in varying risk groups. Arthritis and rheumatism, 2005, Apr-15, Volume: 53, Issue:2 Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Aspirin	2005

lansoprazole and Arthritis